[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atherosclerotic-cardiovascular-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atherosclerotic-cardiovascular-disease":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,15,0,[8,51,83,110,131,155,184,213,241,272,295,317,340,399,431],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":31,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100578595","early-phase-1-placebo-controlled-study-of-single-and-multiple-ascending-doses-of-udp-003-in-healthy-human-participants-and-followed-by-an-open-label-patient-cohort-100578595",false,"NCT06813339","Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Followed by an Open-label Patient Cohort","A Double Blind, Placebo-controlled Study in Healthy Participants to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of UDP-003 and Followed by an Open-label Multiple-dose Patient Cohort","CTx-001","Inclusion Criteria\n\nAll Participants:\n\n1. Participant understands study procedures and provides written informed consent for the trial.\n2. Participant is able to comply with the protocol and the assessments therein.\n\nHealthy Participants (SAD and MAD cohorts):\n\n1. Healthy adult males and females, 18 to 65 years of age (inclusive) at the time of screening.\n2. Adult males and females of body mass index (BMI) ≥ 18 and ≤ 32 kg\u002Fm² and body weight ≥ 50 and ≤ 120 kg.\n3. Social smoking of less than 10 nicotine-containing products per month is acceptable. Absence of tobacco or nicotine containing product (including smoking cessation products) use, for a minimum of 2 weeks prior to dosing is required and will be confirmed by a negative cotinine test at check-in (one retest allowed at the discretion of the investigator).\n4. Medically healthy with relevant renal parameters tests not exceeding 1.5 X the upper limits and no clinically significant screening results (e.g., laboratory profiles, medical history, vital signs, ECGs, physical examination) as deemed by the Principal Investigator; one retest is permitted at investigator discretion.\n\nParticipants with ACS (MD Patient cohort):\n\n1. Adult males and females, 40 to 79 years of age (inclusive) at the time of screening, diagnosed with acute coronary syndrome (ACS), at least 12 months post event (NSTEMI or unstable angina).\n2. Adult males and females of body mass index (BMI) ≥ 18\n3. Medically stable with no clinically significant screening results (e.g., laboratory profiles including relevant renal parameters and liver function tests, medical history, vital signs, ECGs, physical examination) as deemed by the Principal Investigator.\n4. Participants on a stable regimen and dose of ACS treatment including statins, anticoagulants, blood thinners, anti-platelets or other standard of care for 3 months prior to screening and for whom no change in this treatment is planned during the participation in the study.",true,"ALL","18 Years","79 Years",{"count":22,"type":23},84,"ESTIMATED","INTERVENTIONAL",[26],"EARLY_PHASE1","The goal of this clinical trial is to learn if UDP-003 is safe in healthy human participants and patients, assess the pharmacokinetics (PK)\u002Fpharmacodynamics (PD) of UDP-003 in healthy human participants and patients and its potential efficacy in patients.\n\nResearchers will compare UDP-003 to a placebo in a blinded manner.\n\nThis first in human, randomised, double-blind, placebo-controlled, prospective, single-centre trial with a modular dose-finding design will be conducted in 3 parts:\n\n* Part 1: 6 cohorts of 6 healthy participants receiving Single Ascending Doses (SADs),\n* Part 2: 3 cohorts of 12 healthy participants receiving Multiple Ascending Doses (MADs) (6 doses over 16 days),\n* Part 3: 1 cohort of up to 9 evaluable participants diagnosed with acute coronary syndrome (ACS; non-ST elevation myocardial infarction \\[NSTEMI\\] or unstable angina) at least 12 months post-event receiving multiple doses (6 administrations of the 25 mg\u002Fkg dose over 6 weeks).\n\nThe planned duration of the study for each participant will be:\n\n* 4 weeks for SAD Participants (1-day treatment period, 4-week safety follow-up)\n* 6 weeks for MAD Participants (16-day treatment period,4-week safety follow-up)\n* 180 Days for MD Patients (6-week treatment period, 6-month safety follow-up) Prior to participants being randomised to panels of increasing doses, all safety data will be reviewed for completed panels.",[29,30],"Atherosclerotic Cardiovascular Disease","Acute Coronary Syndromes",[32,33,34,35,36,37],"Atherosclerosis","7-ketocholesterol (7KC)","Cyclodextrin","Plaque burden reduction","Healthy Participants","Acute coronary syndrome","RECRUITING","2026-06-26",{"date":41,"type":42},"2026-06-30","ACTUAL",{"date":44,"type":42},"2025-02-25",{"date":46,"type":23},"2027-12-30",{"name":48,"class":49},"Cyclarity Therapeutics, Inc.","INDUSTRY",1,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":18,"minAge":59,"maxAge":60,"enrollmentInfo":61,"targetDuration":4,"studyType":24,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":82},"100595821","phase-3-evaluating-the-impact-of-maridebart-cafraglutide-on-cardiovascular-outcomes-in-participants-with-atherosclerotic-cardiovascular-disease-and-overweight-or-obesity-100595821","NCT07037433","Evaluating the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Impact of Maridebart Cafraglutide on Cardiovascular Outcomes in Participants With Atherosclerotic Cardiovascular Disease and Overweight or Obesity","MARITIME-CV","Inclusion Criteria\n\n* Age ≥ 45 years at screening.\n* BMI of ≥ 27.0 kg\u002Fm\\^2 at screening.\n* History of Atherosclerotic Cardiovascular Disease (ASCVD) with a documented history of at least one of the following:\n\n  * Prior MI (presumed atherothrombotic event due to plaque rupture\u002Ferosion).\n  * Prior ischemic stroke (presumed due to atherosclerosis; may include ischemic stroke with hemorrhagic transformation).\n  * Symptomatic peripheral arterial disease (PAD), as evidenced by intermittent claudication with ankle-brachial index (ABI) \\\u003C 0.9 (at rest), or peripheral arterial revascularization procedure, or amputation due to atherosclerotic disease.\n\nExclusion Criteria\n\n* History of any of the following within 60 days before screening or between screening and randomization: MI, hospitalization for unstable angina, arterial revascularization (eg, coronary, cerebrovascular or peripheral) major cardiovascular surgery, stroke, or transient ischemic attack (TIA).\n* New York Heart Association (NYHA) class IV HF during screening or hospitalization for HF within 60 days before screening or between screening and randomization.\n* Type 1 DM, or any other type of diabetes with the exception of T2DM or prior gestational diabetes. Participants with a history of gestational diabetes should be stratified according to their current diabetes classification.\n* For participants with T2DM (including those without a prior history of T2DM but with a HbA1c ≥ 6.5% during screening):\n\n  * HbA1c \\> 10.0% (86 mmol\u002Fmol) at screening.\n  * History of diabetic ketoacidosis or hyperosmolar state\u002Fcoma within 12 months before randomization.\n  * One or more episodes of severe hypoglycemia within 6 months before randomization and\u002For history of hypoglycemia unawareness.\n  * History of proliferative diabetic retinopathy, diabetic maculopathy, severe non-proliferative diabetic retinopathy, or currently receiving or planning to receive treatment for diabetic retinopathy and\u002For diabetic macular edema.\n* Use of any glucagon-like peptide-1 receptor agonist (GLP-1 RA), glucose-dependent insulinotropic polypeptide (GIP) agonists or antagonists, or amylin analogs within 90 days before randomization or planned use during the conduct of the trial.\n* History of chronic pancreatitis or history of acute pancreatitis in the 180 days before screening or between screening and randomization.\n* Family (first-degree relative\\[s\\]), or personal history of medullary thyroid carcinoma (MTC), or multiple endocrine neoplasia syndrome type 2 (MEN-2).\n* Calcitonin ≥ 50 ng\u002FL (pg\u002FmL) at screening.\n* Acute or chronic hepatitis; signs and symptoms of any liver disease other than metabolic dysfunction-associated steatotic liver disease, or alanine aminotransferase (ALT) \\> 3.0 x the upper limit of normal (ULN) during screening, or total bilirubin (TBL) \\> 1.8 x ULN during screening (for participants with a known diagnosis of Gilbert syndrome, direct bilirubin should be used instead of TBL).\n* History of malignancy within the last 5 years before screening or between screening and randomization (except for the following treated with curative intent: non-melanoma skin cancer, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ).\n* Participants of childbearing potential planning to become pregnant while on study or unwilling to use protocol-specified methods of contraception during treatment.","45 Years","99 Years",{"count":62,"type":23},12800,[64],"PHASE3","The primary objective of this trial is to demonstrate that maridebart cafraglutide is superior to placebo when given as an adjunct to standard of care with respect to reducing cardiovascular (CV) morbidity and mortality.",[29,67,68],"Overweight","Obesity",[29,67,68,70,71,72],"Maridebart cafraglutide","AMG 133","MariTide","2026-06-17",{"date":75,"type":42},"2026-06-18",{"date":77,"type":42},"2025-07-25",{"date":79,"type":23},"2030-09-29",{"name":81,"class":49},"Amgen",774,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":90,"enrollmentInfo":91,"targetDuration":4,"studyType":24,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":109},"100583411","phase-3-pelacarsen-roll-over-extension-program-100583411","NCT06875973","Pelacarsen Roll-over Extension Program","A Rollover Extension Program (REP) to Evaluate the Long-term Safety and Tolerability of Open-Label Pelacarsen in Participants With Elevated Lp(a) and Established ASCVD","Inclusion Criteria:\n\n* Participants who have provided informed consent prior to initiation of any study-specific activities\u002Fprocedures.\n* Participants who have completed the parent study and received the assigned study treatment at the time of its completion\n\nExclusion Criteria:\n\n* Participants who permanently discontinued the study treatment as mandated per protocol or due to adverse events in the parent study\n* Any medical condition(s) in the investigator's opinion that may put the participant at risk or interfere with the study participation\n* Participants who are receiving another investigational drug or device before the open-label treatment period\n* Participants who have a known sensitivity to the study drug and are deemed as unsuited for the study by the investigator\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.","100 Years",{"count":92,"type":23},599,[64],"This non-randomized, rollover extension study will provide post-trial access to pelacarsen (TQJ230) to participants who have successfully completed either of the double-blind parent studies (CTQJ230A12303 or CTQJ230A12304).",[29],[97,98,99],"TQJ230","Lp(a)","ASCVD","2026-06-09",{"date":102,"type":42},"2026-06-11",{"date":104,"type":42},"2025-05-19",{"date":106,"type":23},"2030-12-08",{"name":108,"class":49},"Novartis Pharmaceuticals",97,{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":4,"eligibilityCriteria":116,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":117,"targetDuration":4,"studyType":24,"phases":119,"briefSummary":120,"conditions":121,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":50},"100635346","phase-3-a-phase-iii-study-to-evaluate-the-efficacy-and-safety-of-hrs9531-in-participants-with-atherosclerotic-cardiovascular-disease-100635346","NCT07551492","A Phase III Study To Evaluate the Efficacy And Safety Of HRS9531 In Participants With Atherosclerotic Cardiovascular Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of HRS9531 Injection in Participants With Atherosclerotic Cardiovascular Disease (ASCVD)","Inclusion Criteria:\n\n1. Diagnosed with atherosclerotic cardiovascular disease (ASCVD), and the course of the disease exceeds 3 months\n2. The body mass index (BMI) at the time of screening was ≥24.0 kg\u002Fm ². Patients with type 2 diabetes have a BMI of ≥22.0 kg\u002Fm ²\n\nExclusion Criteria:\n\n1. Screening for myocardial infarction, acute decompensated heart failure, hospitalization due to heart failure, unstable angina pectoris, stroke or transient ischemic attack, coronary revascularization, atrial flutter\u002Ffibrillation ablation, valve repair\u002Freplacement, carotid or peripheral artery recanalization within 30 days prior to the screening\n2. Severe hypoglycemic events or recurrent hypoglycemic events occurred within one month before screening\n3. When screening, there are proliferative retinopathy or macular degeneration requiring acute treatment, painful diabetic neuropathy, diabetic foot ulcers, and intermittent claudication\n4. Coronary revascularization, atrial flutter\u002Ffibrillation ablation, valve repair\u002Freplacement, and carotid or peripheral artery recanalization are planned to be performed during the trial\n5. Those with a history of acute or chronic pancreatitis, acute cholecystitis, or symptomatic or treatment-requiring gallbladder diseases\n6. Any malignant tumor of the organ system has occurred within the past five years, regardless of whether there is evidence of local recurrence or metastasis, except for cured local cutaneous basal cell carcinoma and cervical carcinoma in situ\n7. Pregnant or lactating women, or participants with fertility who are unwilling to take effective contraceptive measures\n8. Those who have had any previous conditions that affected gastric emptying or have undergone gastrointestinal surgery\n9. Diagnosed or suspected as type 1 diabetes, special type diabetes or secondary diabetes\n10. Acute complications of diabetes occurred within one month before screening\n11. There are endocrine diseases that may significantly affect weight",{"count":118,"type":23},9262,[64],"The purpose of the study is to evaluate the impact of HRS9531 on major adverse cardiovascular events (MACE) in patients with atherosclerotic cardiovascular disease. This study adopts an event-driven design and ends when the target number of the primary endpoint event is reached.",[29],"2026-06-04",{"date":124,"type":42},"2026-06-05",{"date":126,"type":42},"2026-05-29",{"date":128,"type":23},"2031-06",{"name":130,"class":49},"Fujian Shengdi Pharmaceutical Co., Ltd.",{"id":132,"slug":133,"hasResults":11,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":4,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":146,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":151,"leadSponsor":152,"locationsCount":50},"100640608","clinical-assessment-and-targeted-imaging-to-characterize-high-risk-atherosclerotic-cardiovascular-disease-of-survivors-in-sjlife-100640608","NCT07594392","Clinical Assessment and Targeted Imaging to Characterize High-Risk Atherosclerotic Cardiovascular Disease of Survivors in SJLIFE","Clinical Assessment and Targeted Imaging to Characterize High-Risk Atherosclerotic Cardiovascular Disease of Survivors in the St. Jude Lifetime Cohort (SJLIFE)","Inclusion Criteria:\n\n\\- SJLIFE Survivor or Control\n\n* Age ≥18 years\n* Enrolled in the St. Jude Lifetime Cohort (SJLIFE)\n* Participant or legal guardian\u002Frepresentative is able and willing to give informed consent.\n\nSJLIFE Survivor only\n\n* Participant has been treated with at least one of the following cancer therapies:\n\nplatinum chemotherapy, neck radiation exposure of at least 1000 centigray (cGy), or chest radiation exposure of at least 1000 cGy (with potential exposure to the heart).\n\nExclusion Criteria:\n\nSJLIFE Survivor or Control\n\n* Previous stroke or intervention for severe carotid arterial disease including carotid endarterectomy or carotid angioplasty and stent placement.\n* Previous myocardial infarction or intervention for severe cardiovascular disease including Coronary Artery Bypass Graft (CABG), coronary stent placement or coronary angioplasty.\n* History of aortic valve replacement\n* Inability or unwillingness of research participant or legal guardian\u002Frepresentative to give written informed consent.\n\nControl Only\n\n* First degree relative of SJLIFE Survivor\n* History of cancer",{"count":139,"type":23},650,"OBSERVATIONAL","Childhood cancer survivors are at increased risk for premature atherosclerotic cardiovascular disease (ASCVD) due to cancer treatment-related exposures, including radiation therapy and platinum-based chemotherapy. Current ASCVD risk assessment tools may underestimate cardiovascular risk in younger survivors. This observational study performs detailed cardiovascular phenotyping using imaging, blood-based biomarkers, and vascular function testing among adult survivors enrolled in the St. Jude Lifetime Cohort (SJLIFE), with comparison to community controls, to better characterize subclinical ASCVD risk and inform survivor-specific prevention strategies.\n\nPrimary Objective:\n\nPerform deeper phenotyping of SJLIFE participants at treatment-related risk of atherosclerotic cardiovascular disease \\[ASCVD\\] to facilitate early detection of pathophysiological targets appropriate for remediation.\n\nSecondary Objectives:\n\nDetermine the distribution of lipoprotein (a) levels and prevalence of elevated levels among survivors with any treatment related exposure-based risk for ASCVD overall and then compared to community controls.\n\nEvaluate prevalence of clinical and imaging markers of ASCVD risk among survivors exposed only to platinum chemotherapy and compare that to community controls.",[29],[144,99],"Childhood Cancer Survivors","NOT_YET_RECRUITING","2026-05-19",{"date":148,"type":42},"2026-05-22",{"date":150,"type":23},"2026-06",{"date":128,"type":23},{"name":153,"class":154},"St. Jude Children's Research Hospital","OTHER",{"id":156,"slug":157,"hasResults":11,"nctId":158,"briefTitle":159,"officialTitle":160,"acronym":161,"eligibilityCriteria":162,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":90,"enrollmentInfo":163,"targetDuration":4,"studyType":24,"phases":165,"briefSummary":167,"conditions":168,"keywords":169,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":179,"completionDateStruct":181,"leadSponsor":183,"locationsCount":50},"100595610","phase-4-study-to-evaluate-the-impact-of-a-targeted-lipid-optimization-program-on-ldl-c-control-in-at-risk-adult-patients-with-dyslipidemia-100595610","NCT07034690","Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia","A Prospective, Type I Hybrid Effectiveness-implementation, Open Label, Randomized Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in at- Risk Adult Patients From Abu Dhabi, United Arab Emirates (UAE) With Dyslipidemia","OPTIMA","Inclusion Criteria:\n\n* Diagnosis of ASCVD (coronary heart disease, peripheral arterial disease and\u002For cerebrovascular disease)\n* High risk or very high risk for cardiovascular events (as per the 2019 ESC\u002FEAS guidelines \\[1\\] for the management of dyslipidemias)\n* Lipid levels:\n\n  * High risk: LDL-C ≥70 mg\u002Fdl (or \\> 1.8 mmol\u002FL) or non-HDL-C ≥100 mg\u002Fdl\n  * Very high risk: LDL-C ≥55 mg\u002Fdl (or \\> 1.4 mmol\u002FL) or non-HDL-C ≥85 mg\u002Fdl\n* Male or Female\n* 18 years or older\n* Seen by a specialist who is prescribing advanced lipid lowering treatments (LLTs) (cardiologist, endocrinologist or any other relevant specialist)\n* Currently taking maximum-tolerated statins\n* Ability to participate in educational program (must be able to watch online videos)\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* Any surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his\u002Fher participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.\n* Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits).\n* Participation in any other interventional study.\n* Inability to travel to study sites for in-person clinic visits.\n* Responsible physician clinical decision not to engage the identified patient.\n* Refusal of the potential participant to sign the consent and be included in the model.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply",{"count":164,"type":23},326,[166],"PHASE4","This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with dyslipidemia who are at high risk or very high risk of cardiovascular events.",[29],[170,171,172,173,174,175],"Dyslipidemia,","ASCVD,","lipid optimization program,","LDL-C target,","educational intervention,","hybrid effectiveness-implementation study","2026-04-28",{"date":178,"type":42},"2026-05-04",{"date":180,"type":42},"2025-11-26",{"date":182,"type":23},"2028-05-31",{"name":108,"class":49},{"id":185,"slug":186,"hasResults":11,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":60,"enrollmentInfo":192,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":194,"conditions":195,"keywords":198,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":4},"100634749","a-real-world-study-of-long-term-adherence-and-persistence-to-inclisiran-evolocumab-and-alirocumab-100634749","NCT07543731","A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab","Real-World Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and Alirocumab in Italy","VICTORION-LEAP","Inclusion criteria:\n\n* A first ever prescription of injection of inclisiran, evolocumab, or alirocumab during the identification period.\n* Age ≥18 years at index date.\n* With at least 12 months data availability prior to index date.\n\nExclusion criteria:\n\n• Patients who received either evolocumab or alirocumab as their index study drug and who were dispensed the other anti-PCSK9-mAb (alirocumab and evolocumab respectively) before the identification period.",{"count":193,"type":23},5995,"This study aims to evaluate the long-term adherence and persistence to inclisiran and anti-proprotein convertase subtilisin\u002Fkexin type 9 (PCSK9) monoclonal antibodies (mAbs) in real-world clinical practice.",[196,29,197],"Cardiovascular Diseases","Hypercholesterolemia, Familial",[199,200,201,202,203,204],"Real-world","Retrospective","Adherence","Persistence","Long-term","PCSK9i","2026-04-14",{"date":207,"type":42},"2026-04-22",{"date":209,"type":23},"2026-04-21",{"date":211,"type":23},"2026-09-30",{"name":108,"class":49},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":4,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":220,"minAge":221,"maxAge":59,"enrollmentInfo":222,"targetDuration":4,"studyType":24,"phases":224,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":232,"lastUpdatePostDateStruct":233,"startDateStruct":235,"completionDateStruct":237,"leadSponsor":238,"locationsCount":240},"100548735","phase-1-fish-oil-metformin-and-heart-health-in-pcos-100548735","NCT06424860","Fish Oil, Metformin and Heart Health in PCOS","Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS","Inclusion Criteria:\n\n* diagnosis of PCOS\n* overweight-obese (BMI \\>25 kg\u002Fm2)\n* elevated fasting plasma TG (\\>150 mg\u002FdL)\n* and\u002For apoB48-remnant cholesterol lipoproteins (\\>20 ug\u002Fml)\n* impaired insulin sensitivity (glucose 100-125 mg\u002FdL and\u002For insulin \\>15 (uM\u002Fml), and may be diagnosed with T2D (blood glucose \\>126 mg\u002FdL).\n\nExclusion Criteria:\n\n-pregnancy, lactation","FEMALE","25 Years",{"count":223,"type":23},146,[225],"PHASE1","Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.",[228,229,29,230,231],"PCOS","Cardiovascular Disease","Atherosclerotic Plaque","Cardiac Hypertrophy","2025-12-04",{"date":234,"type":42},"2025-12-12",{"date":236,"type":42},"2025-11-01",{"date":46,"type":23},{"name":239,"class":154},"University of Alberta",3,{"id":242,"slug":243,"hasResults":11,"nctId":244,"briefTitle":245,"officialTitle":246,"acronym":247,"eligibilityCriteria":248,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":249,"enrollmentInfo":250,"targetDuration":4,"studyType":24,"phases":252,"briefSummary":254,"conditions":255,"keywords":257,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":50},"100590059","polygenic-risk-score-implementation-and-stratification-for-managing-blood-pressure-100590059","NCT06962488","Polygenic Risk Score Implementation and Stratification for Managing Blood Pressure","Clinical Implementation of Blood Pressure Polygenic Risk Score","PRISM-BP","Inclusion Criteria:\n\n* Age 18 to 55 years (inclusive) at the time of screening.\n* Diagnosis of hypertension defined by 2017 ACC\u002FAHA guidelines, as evidenced by Resting office systolic blood pressure (SBP) of 130-160 mm Hg or Resting office diastolic blood pressure (DBP) of 80-100 mm Hg or Current use of antihypertensive medication.\n* Poor cardiovascular health, defined as Life's Essential 8 score \\\u003C50.\n* Willing and able to undergo 24-hour ambulatory blood pressure monitoring (ABPM) to confirm hypertension.\n* Able to provide informed consent.\n\nExclusion Criteria:\n\n* History of cardiovascular disease, including Myocardial infarction, Angina, Cardiac arrhythmia, Coronary heart disease, Heart failure, Stroke, or transient ischemic attack.\n* Body mass index (BMI) \\\u003C18.5 kg\u002Fm² or \\>45 kg\u002Fm².\n* Baseline office SBP \\>160 mm Hg or DBP \\>100 mm Hg.\n* Use of more than two antihypertensive medication classes.\n* Not hypertensive based on 24-hour ABPM (per 2017 ACC\u002FAHA criteria).\n* Pregnant or breastfeeding.\n* Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73 m² (using CKD-EPI equation).\n* Urine albumin-to-creatinine ratio ≥30 mg\u002Fg.\n* Hepatic transaminase levels \\>3× the upper limit of normal.\n* Significant psychiatric illness (assessed via Global Health Questionnaire-12).\n* Moderate or severe anxiety (Beck Anxiety Inventory \\[BAI\\] score \\>16).","55 Years",{"count":251,"type":23},300,[253],"NA","In a multi-ethnic population, a genome-wide polygenic risk score (PRS) for systolic blood pressure (SBP), incorporating over one million common genetic variants, predicts blood pressure (BP) traits and the risk of adverse cardiovascular events beyond traditional risk factors. Delivering SBP PRS information to young and middle-aged adults with hypertension (HTN) and poor cardiovascular health (CVH) may enhance their motivation to adopt healthier lifestyles, improve blood pressure control, and ultimately reduce the risk of future cardiovascular disease (CVD). This randomized controlled trial will assess the impact of SBP PRS disclosure and theory-based genomic counseling on systolic blood pressure and health behaviors. A total of 300 adults aged 18-55 years will be enrolled and randomized to receive either routine clinical care or SBP PRS results with structured genomic counseling based on the Health Belief Model (HBM). Participants will be followed for 12 months. The primary outcome is change in 24-hour mean SBP from baseline to one year. Secondary outcomes include changes in physical activity, diet, medication adherence, smoking, lipid and glucose levels, and body composition. The study will also evaluate how behavior change is influenced by health beliefs, including perceived risk and self-efficacy. This study aims to advance the use of genomic tools in hypertension management and cardiovascular disease prevention.",[256,29],"Hypertension",[258,259,260,261,262],"Systolic Blood Pressure","Polygenic Risk Score","Genomic Counseling","Health Belief Model","Cardiovascular Health","2025-09-02",{"date":265,"type":42},"2025-09-03",{"date":267,"type":42},"2025-08-01",{"date":269,"type":23},"2030-07-31",{"name":271,"class":154},"University of Alabama at Birmingham",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":276,"acronym":277,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":60,"enrollmentInfo":279,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":281,"conditions":282,"keywords":283,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":267,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":294},"100582055","lipoproteina-levels-in-patients-with-atherosclerotic-cardiovascular-diseases-in-russia-100582055","NCT06858332","Lipoprotein(a) Levels in Patients With Atherosclerotic Cardiovascular Diseases in Russia","STaRT","Inclusion Criteria:\n\n1. Written informed consent (signed and dated).\n2. Males and females aged ≥18 years.\n3. Presence of one of the following ASCVDs for at least 3 months within the 2 years prior to signing the informed consent to participate in this study:\n\n   * history of MI;\n   * history of IS and\u002For TIA;\n   * IHD confirmed by coronary angiography (stenosis ≥50%);\n   * any revascularization surgery (emergency or planned), including CABG, PCI, carotid endarterectomy or carotid\u002Fintracranial stenting;\n   * peripheral artery disease (intermittent claudication with ankle-brachial index ≤0.90 and\u002For lower limb amputation or revascularization in case of lower limb ischemia).\n\nExclusion Criteria:\n\n1. Acute infectious and inflammatory diseases, such as COVID-19, in the month leading up to the Screening visit.\n2. Lp(a)-lowering therapy\u002Fmethods (Lp(a) apheresis with PCSK9 inhibitors, inclisiran prior to the Screening visit) in the medical history before the Screening visit.\n3. Participation in any interventional clinical study with investigational or marketed medicinal products at the time of enrollment.\n4. Participation in other real-world clinical studies.\n5. Stages 4 and 5 of chronic kidney disease (glomerular filtration rate CKD-EPI \\\u003C30 mL\u002Fmin\u002F1.73 m2) and\u002For hepatic disease (total bilirubin: 2 × ULN).\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply.",{"count":280,"type":23},2382,"This study has the purpose to answer how the Lipoprotein(a) (Lp(a)) level is distributed among Atherosclerotic cardiovascular disease (ASCVD) patients in Russia, and what is the connection between elevated levels of this parameter and the cardiovascular disease (CVD) risk.",[29],[284,171,285,286],"lipoprotein(a),","cardiovascular disease,","CVD",{"date":288,"type":42},"2025-08-03",{"date":290,"type":42},"2025-04-15",{"date":292,"type":23},"2027-09-30",{"name":108,"class":49},20,{"id":296,"slug":297,"hasResults":11,"nctId":298,"briefTitle":299,"officialTitle":300,"acronym":301,"eligibilityCriteria":302,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":303,"targetDuration":4,"studyType":24,"phases":305,"briefSummary":306,"conditions":307,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":308,"lastUpdatePostDateStruct":309,"startDateStruct":311,"completionDateStruct":313,"leadSponsor":315,"locationsCount":50},"100559978","a-pragmatic-initiative-for-ldl-c-management-by-a-clinical-pharmacist-led-team-among-atherosclerotic-cardiovascular-disease-patients-100559978","NCT06571162","A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients","A Pragmatic INitiative for LDL-C Management by a CLinical Pharmacist-Led Team Among Atherosclerotic CardiovascUlar DisEase Patients (The INCLUDE Trial)","INCLUDE","Inclusion Criteria:\n\n1. Male or female \\>18 years of age\n2. Receive follow-up care with Intermountain Health\n3. Value-based patient (as defined in the EDW)\n4. Documentation of an ASCVD diagnosis, by 1 of the following:\n\n   * Coronary artery disease (Primary inpatient CAD diagnosis during index encounter; Primary inpatient MI diagnosis during index encounter; PCI during index encounter; or CABG during index encounter\n   * Cerebrovascular accident (Primary inpatient ischemic stroke diagnosis during index encounter; Carotid endarterectomy during index encounter; or Carotid stent during index encounter)\n   * Peripheral arterial disease (Bypass or percutaneous intervention during index encounter)\n\nExclusion Criteria:\n\n1. Patient age \\\u003C18 years.\n2. Receipt of or expected receipt of palliative care, expected discharge to hospice, or long-term care facility (i.e., skilled nursing facility).\n3. Pregnant or lactating women",{"count":304,"type":23},400,[253],"Patients who had an ASCVD event at an Intermountain hospital will be screened for eligibility to be randomized. Subjects who meet eligibility criteria will be randomized 1:1 to receive targeted care of their LDL-C through a pharmacist-driven management program or not. Patients may opt-out of receiving LDL-C management by the pharmacy team at any time. The purpose of this program is to increase the proportion of patients who achieve guideline-based recommendations of LDL-C levels of \\\u003C70 mg\u002FdL by increasing statin and\u002For LLT adherence and LDL-C testing. Data collection as part of the study will continue until the last person randomized has had 1-year of follow-up.",[29],"2025-05-01",{"date":310,"type":42},"2025-05-06",{"date":312,"type":42},"2025-01-30",{"date":314,"type":23},"2028-09",{"name":316,"class":154},"Intermountain Health Care, Inc.",{"id":318,"slug":319,"hasResults":11,"nctId":320,"briefTitle":321,"officialTitle":321,"acronym":322,"eligibilityCriteria":323,"healthyVolunteers":11,"sex":18,"minAge":324,"maxAge":325,"enrollmentInfo":326,"targetDuration":4,"studyType":24,"phases":328,"briefSummary":329,"conditions":330,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":331,"lastUpdatePostDateStruct":332,"startDateStruct":334,"completionDateStruct":336,"leadSponsor":338,"locationsCount":50},"100554085","phase-3-the-prevent-coronary-artery-disease-trial-100554085","NCT06494501","The Prevent Coronary Artery Disease Trial","PRECAD","Inclusion Criteria:\n\n* Male or female subjects between 30 to 50 years of age.\n* No prior history of coronary artery disease, cerebrovascular disease or peripheral artery disease.\n* Serum LDL-C \\> 1.8 mmol\u002Fl (70 mg\u002Fdl).\n* Presence of subclinical atherosclerosis as assessed by 3DVUS or by the presence of coronary artery calcium (defined as coronary artery calcium score ≥25), independent of risk calculators; and\u002For high lifetime risk (≥30%) using the ASCVD calculator; and\u002For intermediate 10-year risk (≥7.5%) using the ASCVD calculator in the presence of 2 risk enhancers.\n\nThe presence of atherosclerotic plaque by 3DVUS will be defined according to the PESA study definitions14: plaque is defined as a focal protrusion into the arterial lumen of thickness \\>0.5 mm or \\>50% if the intima media thickness or intima media thickness \\>1.5 mm. CT scan for coronary artery calcium assessment will not be part of the protocol but will be used where available.\n\nRisk enhancers are defined as15:\n\n* Family history of premature atherosclerotic CVD\n* Persistently elevated LDL-C ≥ 160 mg\u002Fdl\n* Chronic kidney disease\n* Metabolic syndrome\n* Conditions specific to women (e.g. preeclampsia, premature menopause)\n* Inflammatory diseases (especially rheumatoid arthritis, psoriasis, HIV)\n* Ethnicity (e.g., South Asian ancestry)\n* Persistently elevated triglycerides (≥175 mg\u002Fdl)\n* Hs-CRP ≥2 mg\u002FL\n* Lp(a) levels \\>50 mg\u002Fdl\n* apoB ≥130 mg\u002Fdl\n* Ankle-brachial index \\\u003C0.9\n\nExclusion Criteria:\n\nAny uncontrolled or serious disease, or any medical or surgical condition, that may either interfere with participation in the clinical study, and\u002For put the subject at significant risk (according to investigator's \\[or delegate\\] judgment) if he\u002Fshe participates in the clinical study.\n\n* An underlying known disease, or surgical, physical, or medical condition that, in the opinion of the investigator (or delegate) might interfere with interpretation of the clinical study results.\n* Females who are pregnant or nursing, or who are of childbearing potential and unwilling to use at least two methods of highly effective contraception (failure rate less than 1% per year) (e.g. combined oral contraceptives, barrier methods, approved contraceptive implant, long- term injectable contraception, or intrauterine device) for the entire duration of the study.\n* Severe concomitant non-cardiovascular disease that carries the risk of reducing life expectancy to less than 5 years.\n* History of malignancy that required surgery (excluding local and wide-local excision), radiation therapy and\u002For systemic therapy during the three years prior to randomization\n* Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver or unexplained elevations in ALT, aspartate aminotransferase (AST), \\>3x the ULN, or total bilirubin \\>2x ULN at screening confirmed by a repeat abnormal measurement at least 1 week apart.\n* Known contraindications to anti-lipid therapy\n* Known history of alcohol and\u002For drug abuse within the last 5 years.\n* Treatment with other investigational products or devices within 30 days or five half- lives of the screening visit, whichever is longer.\n* Planned use of other investigational products or devices during the course of the study.\n* Any condition that according to the investigator could interfere with the conduct of the study, such as but not limited to:\n\n  * Subjects who are unable to communicate or to cooperate with the investigator.\n  * Unable to understand the protocol requirements, instructions and study-related restrictions, the nature, scope, and possible consequences of the study (including subjects whose cooperation is doubtful due to drug abuse or alcohol dependency).\n  * Unlikely to comply with the protocol requirements, instructions, and study- related restrictions (e.g., uncooperative attitude, inability to return for follow-up visits, and improbability of completing the study).\n  * Have any medical or surgical condition, which in the opinion of the investigator would put the subject at increased risk from participating in the study.\n  * Persons directly involved in the conduct of the study.\n* Treatment (within 90 days of screening) with monoclonal antibodies directed towards PCSK9.\n* History of hypersensitivity to the study treatment or its excipients or to other siRNA drugs.","30 Years","50 Years",{"count":327,"type":23},1600,[64],"Despite increasing evidence that exposure to cardiovascular risk factors (CVRF) at an early age increases the prevalence of subclinical atherosclerosis and is associated with a greater risk of cardiovascular events later in life, there is a lack of randomized trial evidence to support primary prevention strategies in adults aged 30-50 years. The researchers have designed a randomized controlled trial to evaluate whether strict control of CVRF in young adults without known cardiovascular disease, will reduce the progression of total atherosclerosis burden, a surrogate endpoint for symptomatic cardiovascular disease, compared with usual care.\n\nThe researchers propose a randomized controlled trial enrolling 1,600 healthy young adults who meet the inclusion criteria and who do not meet any exclusion criteria. Eligible study participants will be randomized, in a 1:1 ratio, to either the intervention group (active treatment strategy) or to the control group (guideline-directed medical therapy). Randomization will be stratified by the presence or absence of atherosclerotic plaque in vascular ultrasound.",[29],"2025-04-24",{"date":333,"type":42},"2025-04-29",{"date":335,"type":42},"2024-09-12",{"date":337,"type":23},"2032-06-30",{"name":339,"class":154},"Icahn School of Medicine at Mount Sinai",{"id":341,"slug":342,"hasResults":11,"nctId":343,"briefTitle":344,"officialTitle":345,"acronym":346,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":24,"phases":350,"briefSummary":351,"conditions":352,"keywords":359,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":390,"lastUpdatePostDateStruct":391,"startDateStruct":393,"completionDateStruct":395,"leadSponsor":397,"locationsCount":50},"100557713","coated-or-chewable-aspirin-and-a-hybrid-strategy-to-mitigate-adverse-effects-of-air-pollution-in-stable-atherosclerotic-disease-100557713","NCT06541691","Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic Disease","Coated or Chewable Aspirin in Patients with Established Atherosclerotic Disease and a Hybrid Strategy to Mitigate the Adverse Effects of Air Pollution: the COATED-AIR Randomized Clinical Trial","COATED-AIR","Inclusion Criteria:\n\n* Adult patients (≥18 years) with documented ASCVD defined as at least one of the following:\n\n  * Coronary artery disease (CAD):\n\n    1. Previous or recent documented type I myocardial infarction \\*(if not specified, will be assumed as type I)\n    2. History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass graft surgery)\n    3. History of obstructive CAD (\\>50% stenosis) documented by coronary computed tomography (CT) or conventional angiography\n  * Peripheral arterial disease (PAD):\n\n    1. Previous or recent acute ischemic limb event (\\>7 days prior)\n    2. History of previous endovascular\u002Fsurgical lower or upper extremities revascularization for an atherosclerotic cause\n    3. History of ulcer or lower extremities amputation due to ASCVD.\n  * Carotid arterial diseases:\n\n    1. History of previous endovascular\u002Fsurgical carotid artery revascularization for atherosclerotic causes\n    2. History of \\> 50% carotid artery stenosis based on documented imaging tests (Duplex US, CT angiography, magnetic resonance angiography, or conventional angiography)\n  * Ischemic stroke:\n\n    1. History of recent or previous documented ischemic stroke not due to atrial fibrillation, endocarditis, or systemic hypoperfusion\u002Fhypotension, being treated with low-dose aspirin\n* Inhabitant of Tehran province\n* Willing to participate and able to provide written informed consent\n\nExclusion Criteria:\n\n* Being within 72 days of acute\u002Funstable atherosclerotic cardiovascular events (acute myocardial infarction, acute limb event, and acute ischemic stroke), or within 72 hours of revascularization.\n* Patients receiving triple antithrombotic therapy\n* History of upper gastrointestinal bleeding within the past 30 days\n* History of intracranial hemorrhage within the past 30 days\n* End-stage kidney disease with estimated creatinine clearance \\\u003C 15 mL\u002Fmin, or undergoing hemodialysis or peritoneal dialysis\n* Known comorbidities associated with poor prognosis (e.g., metastatic cancer) in conjunction with an estimated life expectancy of less than one year according to the treating clinician\n* Any other conditions that make the participants unsuitable for recruitment or follow-up (e.g., illiteracy)\n* Not having aspirin as part of the planned durable treatment regimen\n* Inability to receive\u002Fread text messages\u002Fphone calls by personal mobile phone (or that of a caregiver who lives with the patient and is willing to relay messages)\n\n  * The full list of exclusion criteria is provided in the study protocol",{"count":349,"type":23},3000,[253],"Although both enteric-coated and plain formulations of aspirin are being used commonly, there are no high-quality comparisons between these formulations with respect to clinical efficacy outcomes in patients with atherosclerotic cardiovascular diseases (ASCVD). Air pollution is also a major contributor to the excess risk of cardiovascular events in many regions of the world. However, little is known about the effect of individual-level mitigation strategies against air pollution in reducing cardiovascular outcomes. The purpose of the first randomization is to compare the efficacy and safety of enteric-coated versus plain low-dose (81 mg) aspirin formulations in a double-blind fashion. The second randomization compares a multifaceted intervention including one-page educational flashcard, cell phone text messages alerting participants on polluted days, recommending them to stay indoors or wear KN-95 facemasks provided by the study team in case of necessary outdoor activity, and recommendation to consume citrus fruits on polluted days versus usual care. Both randomization are powered for clinical outcomes and the results will inform practice.",[29,353,354,355,356,357,358],"Coronary Artery Disease","Ischemic Heart Disease","Ischemic Stroke","Peripheral Arterial Disease","Carotid Artery Stenosis","Carotid Atherosclerosis",[360,361,362,363,364,365,366,367,368,369,370,371,372,373,374,375,376,377,378,379,380,381,382,383,384,385,386,387,388,389],"atherosclerosis","atherosclerotic cardiovascular disease","atherosclerotic arterial disease","atherosclerotic plaque","coronay artery disease","ischemic heart disease","atherosclerotic disease","ischemic stroke","peripheral arterial disease","carotid artery stenosis","carotid atherosclerosis","myocardial infarction","acute limb ischemia","bleeding","major bleeding","gastrointestinal bleeding","gastrointestinal ulcer","peptic ulcer disease","gastric ulcer","duodenal ulcer","dyspepsia","intracerebral hemorrhage","aspirin","acetylsalicylic acid","antithrombotic therapy","antithrombotic agents","antiplatelet agents","air pollution","cerebral hemorrhage","hemorrhage","2025-03-14",{"date":392,"type":42},"2025-03-19",{"date":394,"type":42},"2024-03-06",{"date":396,"type":23},"2027-03-30",{"name":398,"class":154},"Rajaie Cardiovascular Medical and Research Center",{"id":400,"slug":401,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":18,"minAge":406,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":24,"phases":409,"briefSummary":410,"conditions":411,"keywords":414,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":421,"lastUpdatePostDateStruct":422,"startDateStruct":424,"completionDateStruct":426,"leadSponsor":428,"locationsCount":50},"100498062","ldl-cholesterol-targets-in-older-patients-age75-years-with-ascvd-target-old-100498062","NCT05765370","LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With ASCVD (TARGET OLD)","LDL Cholesterol TARGETs in OLDer Patients (Age≥75 Years) With Atherosclerotic Cardiovascular Disease (TARGET OLD)","Inclusion Criteria:\n\n1. Men or women ≥75 years of age\n2. Diagnosis of clinical atherosclerotic cardiovascular disease (ASCVD) with one or more of the following:\n\n   1. Diagnosis of coronary heart disease (one or more of the following criteria must be satisfied):\n\n      * Hospitalization for acute coronary syndrome\n      * Treatment or hospitalization for stable angina pectoris with documented ischemia on invasive or noninvasive testing\n      * History of myocardial infarction\n      * History of coronary revascularization procedure (eg, percutaneous coronary intervention \\[PCI\\] or coronary artery bypass graft surgery \\[CABG\\])\n      * Invasive diagnostic coronary angiography indicating \\>50% stenosis in at least one major epicardial coronary artery or CT-imaging (eg, CCTA\u002FMDCT) evidence of coronary atherosclerosis (\\>50% stenosis in at least two major epicardial coronary artery)\n   2. Diagnosis of atherosclerotic cerebrovascular or carotid disease (one or more of the following criteria must be satisfied):\n\n      * History of ischemic stroke or transient ischemic attack (TIA) confirmed by symptoms with a documented ischemic lesion on CT or MRI in the cerebral regions corresponding to the symptoms;\n      * Documented intracranial atherosclerotic stenosis on the basis of conventional cerebral angiography, magnetic resonance angiography, CT angiography, transcranial doppler ultrasound, and high-resolution MRI;\n      * Symptomatic carotid artery disease with ≥50% carotid arterial stenosis;\n      * Asymptomatic carotid artery disease with ≥70% carotid arterial stenosis per angiography or duplex ultrasound;\n      * History of carotid revascularization (catheter-based or surgical).\n   3. Diagnosis of atherosclerotic peripheral artery disease (one or more of the following criteria must be satisfied):\n\n      * History of aorto-iliac or peripheral arterial intervention (catheter-based or surgical).\n      * Prior non-traumatic amputation of a lower extremity due to peripheral artery disease\n      * History of intermittent claudication and one or more of the following:\n\n        1. An ankle\u002Farm blood pressure (BP) ratio \\\u003C 0.90, or\n        2. Significant peripheral artery stenosis (≥50%) documented by angiography, or by duplex ultrasound\n3. Baseline LDL-C level should be satisfied:\n\n   * Patients were required to have a baseline LDL-C level ≥100mg\u002FdL (2.6mmol\u002FL) if they were taking a regimen of lipid-lowering therapy \\\u003C4 weeks or they had not previously received lipid-lowering therapy.\n   * Patients were required to have a baseline LDL-C level ≥70mg\u002FdL (1.8mmol\u002FL) if they were on stable treatment with lipid-lowering therapy ≥4 weeks\n4. Signed written informed consent.\n\nExclusion Criteria:\n\n1. Subject was clinically unstable:\n\n   1. Hypotension, defined as sustained systolic blood pressure of \\\u003C90 mmHg due to cardiac failure with associated symptoms;\n   2. Unstable or severe pulmonary edema\u002Fdecompensated congestive heart failure;\n   3. Acute mitral regurgitation or acute ventricular septal defect;\n   4. Cardiogenic shock and\u002For need for mechanical\u002Fpharmacologic hemodynamic support\n   5. Ongoing Non-STEMI with biomarkers (cardiac troponin) still rising\n   6. Recent STEMI (≤7 days prior to randomization)\n   7. Recurrent symptoms of cardiac ischemia\n2. Moderate to severe heart failure (New York Heart Association \\[NYHA\\] Functional Classification III or IV) or last known left ventricular ejection farction (LVEF) \\\u003C40%.\n3. Severe renal dysfunction, defined as creatinine clearance \\\u003C30 mL\u002Fmin or estimated glomerular filtration (eGFR) rate less than 30 ml\u002Fmin\u002F1.73 m2, or requirement for peritoneal dialysis or hemodialysis for renal insufficiency.\n4. History of hemorrhagic stroke or unknown classified stroke.\n5. Uncontrolled or recurrent ventricular tachycardia (such as ventricular fibrillation, recurrent and highly symptomatic ventricular tachycardia, complete heart block, atrial fibrillation with rapid ventricular response, or supraventricular tachycardia that are not controlled by medications).\n6. Uncontrolled hypertension (greater than 180 mm Hg systolic and\u002For greater than 110 mm Hg diastolic at randomization visit).\n7. History or clinical evidence of active liver disease or hepatic dysfunction, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\> 3 × upper limit of normal (ULN), or total bilirubin \\> 2 × ULN.\n8. Unexplained elevated creatine kinase (CK) concentration \\>5 × ULN or elevation due to known muscle disease.\n9. Planned or expected cardiac surgery, PCI or carotid stenting, or planned major noncardiac surgery during the study period. If angiography or revascularization is planned, patients may be screened and enrolled after all such planned procedures are completed.\n10. Active Malignancy (except nonmelanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in situ, or stage 1 prostate carcinoma) including those patients requiring surgery, chemotherapy, and\u002For radiation in the past 3 years.\n11. Drug or alcohol abuse, and inability\u002Funwillingness to abstain from drug abuse and excessive alcohol consumption during the study.\n12. Severe, concomitant noncardiovascular disease that is expected to reduce life expectancy to \\\u003C3 years\n13. Currently receiving treatment in another investigational device or drug study, or less than 30 days since ending treatment on another investigational device or drug study(ies), or receiving other investigational agent(s)\n14. Subject has received drugs via a systemic route that have known major interactions with background statin therapy (eg, itraconazole, ketoconazole, and other antifungal azoles, erythromycin, clarithromycin, or cyclosporine nefazodone) within 1 month prior to randomization or is likely to require such treatment during the study period.\n15. Recipient of any major organ transplant (eg, lung, liver, heart, bone marrow, renal)\n16. Subject likely to not be available to complete all protocol-required study visits or procedures, and\u002For to comply with all required study procedures (eg, Clinical Outcome Assessments) to the best of the subject and investigator's knowledge.\n17. Any uncontrolled or serious disease, or any medical or surgical condition (such as known active infection or major hematologic, renal, metabolic, gastrointestinal or endocrine dysfunction, or a chronic disease or infection \\[eg, HIV\\]), that may either interfere with participation in the clinical study and is not currently stable and appropriately managed in the judgment of the investigator, and\u002For put the subject at significant risk (according to investigator's judgment) if he\u002Fshe participates in the clinical study.\n18. Mental\u002Fpsychological impairment\u002Fneurocognitive disorder, or any other reason to expect patient difficulty in complying with the requirements of the study or understanding the goal and potential risks of participating in the study","75 Years",{"count":408,"type":23},4200,[253],"To determine whether treating to an LDL-C target of 25 to \\\u003C70 mg\u002FdL is superior to an LDL-C target of 70 to \\\u003C100 mg\u002FdL with respect to major cardiovascular events (cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina, or coronary revascularization) in patients aged ≥75 years with atherosclerotic cardiovascular disease (ASCVD).\n\nTo determine whether treating to an LDL-C target of 25 to \\\u003C70 mg\u002FdL is non-inferior to an LDL-C target of 70 to \\\u003C100 mg\u002FdL with respect to major safety events (hemorrhagic stroke, new-onset diabetes, muscle-related events, neurocognitive adverse events, new or recurrent cancer, cataract, or hepatic disorder \\[Alanine aminotransferase (ALT)\u002FAspartate aminotransferase (AST) \\>3× ULN, or total bilirubin \\>2× ULN\\]) in patients aged ≥75 years with ASCVD.",[29,412,413],"Older Patients","LDL Cholesterol",[415,29,416,417,418,419,420],"LDL-C target","Older patients","Age≥75 years","Lipid-lowering therapy","Stain","PCSK9 inhibitor","2023-04-07",{"date":423,"type":42},"2023-04-10",{"date":425,"type":42},"2023-03-24",{"date":427,"type":23},"2026-12-24",{"name":429,"class":430},"China National Center for Cardiovascular Diseases","OTHER_GOV",{"id":432,"slug":433,"hasResults":11,"nctId":434,"briefTitle":435,"officialTitle":436,"acronym":4,"eligibilityCriteria":437,"healthyVolunteers":11,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":438,"targetDuration":4,"studyType":140,"phases":4,"briefSummary":439,"conditions":440,"keywords":4,"overallStatus":145,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":50},"100461899","atherosclerotic-cardiovascular-risk-in-childhood-and-teen-age-onset-diabetes-100461899","NCT05294653","Atherosclerotic Cardiovascular Risk in Childhood and Teen-age Onset Diabetes","Risk of Atherosclerotic Cardiovascular Disease in Childhood and Teen-age Onset Diabetes","Inclusion Criteria:\n\n1. Diagnosis of type 1 diabetes or type 2 diabetes\n2. Age of onset: \\\u003C18y\n3. Enrollment age: ≥18y\n4. Gender: male or female\n5. Diabetes duration ≥ 5 years\n\nExclusion Criteria:\n\n1. Specific types of diabetes\n2. Clinical diagnosis of diabetes is unknown, and it belongs to untyped diabetes\n3. Pregnancy or lactation\n4. Received glucocorticoids, immunosuppressants, non-glycemic biological agents, and cytotoxic drugs in the past 3 months; non-steroidal pain relievers or antibiotics used for more than 1 week continuously\n5. Onset of acute complications of diabetes in the past 3 months\n6. Major trauma and surgery history in the past 3 months",{"count":251,"type":23},"For children and adolescents with diabetes, the pathological process of atherosclerotic cardiovascular disease(ASCVD) can exist in early childhood and progress rapidly to subclinical ASCVD. This study intends to explore the models for the prediction of ASCVD risk in childhood and teen-age onset diabetes with different types.",[29,441,442],"Childhood Diabetes Mellitus","Juvenile Diabetes","2022-05-20",{"date":445,"type":42},"2022-05-23",{"date":447,"type":23},"2022-06-01",{"date":449,"type":23},"2027-01-01",{"name":451,"class":154},"Shanghai Jiao Tong University School of Medicine"]