[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ascvd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ascvd":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,47,73,120,149,175,201,222,250,272,304],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100569205","phase-2-effects-of-il-1-beta-inhibition-on-vascular-inflammation-in-tet2-clonal-hematopoiesis-100569205",false,"NCT06691217","Effects of IL-1 Beta Inhibition on Vascular Inflammation in TET2 Clonal Hematopoiesis","TECTONIC","Inclusion Criteria:\n\n* 18 years or older\n* Coronary artery disease, defined as prior heart attack, coronary stent procedure \\>180 days before baseline imaging, or advanced subclinical coronary atherosclerosis (coronary artery calcium score ≥300 Agatston units, CAD-RADS 3 or greater atherosclerosis on coronary CT angiography, or qualitatively severe coronary artery calcification identified on non-gated CT imaging)\n* Presence of either TET2 mutations or no myeloid driver mutations on prior sequencing\n\nExclusion Criteria:\n\n* placement of a drug-eluting stent in a proximal coronary arterial segment \\\u003C180 days before baseline imaging\n* prior coronary artery bypass grafting\n* pregnancy or breastfeeding\n* history of blood malignancy or current solid-tumor malignancy\n* history of organ or stem cell transplantation\n* current treatment with prescription, systemic (oral, IV \\[intravenous\\], or IM \\[intramuscular\\]) steroids or anti-inflammatory\u002Fimmune suppressant medical therapies (including colchicine but excluding topical therapies, UV therapy, ASA-derivative therapies, or NSAIDS) for autoimmune\u002Finflammatory diseases, post-transplant care, asthma, or pain\n* use of oral steroids or prescription oral anti-inflammatory\u002Fimmune suppressant medication for \\>7 days within the past 1 month\n* use of IV or IM steroids or IV or IM anti-inflammatory\u002Fimmune suppressant medication within the past 3 months\n* known allergy to dextran's and\u002For DTPA and\u002For radiometals and\u002For severe allergy to iodinated contrast media\n* estimated glomerular filtration rate (eGFR) \\\u003C 45 ml\u002Fmin\u002F1.73 m2\n* contraindications to nitroglycerin known narrow angle glaucoma, or known severe aortic stenosis\n* use of phosphodiesterase type 5 inhibitor AND refusal to abstain from use of these medications within the 5 days prior to scheduled CCTA scan\n* significant radiation exposure (40msV) received within the past 12 months\n* concurrent enrollment in another research study judged by the investigators to interfere with the current study\n* known active or recurrent hepatic disease (including cirrhosis or ALT\u002FAST levels \\>3 times the upper limit oof or total bilirubin \\>2 times the upper limits of normal)\n* history or evidence of tuberculosis (TB) (active or latent) infection or risk factor for TB\n* active bacterial, fungal or viral infection at the time of enrollment or history of recurrent infections\n* suspected or proven immunocompromised state\n* live vaccinations within 3 months prior to randomization visit or live vaccinations planned during the trial","ALL","18 Years",{"count":19,"type":20},120,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","The primary goal of this clinical trial is to test the hypothesis that the drug canakinumab (anti-IL-1B monoclonal antibody) decreases vascular inflammation when used by people with a history of coronary artery disease, including those with and without clonal hematopoiesis driven by mutations in TET2.",[26,27,28],"Vascular Inflammation","ASCVD","ASCVD Management",[30,31,32,26,27,33],"CHIP","TET2 CHIP","Clonal Hematopoiesis","ASCVD management","RECRUITING","2026-06-16",{"date":37,"type":38},"2026-06-18","ACTUAL",{"date":40,"type":38},"2026-03-24",{"date":42,"type":20},"2030-04-01",{"name":44,"class":45},"Massachusetts General Hospital","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":21,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":67,"leadSponsor":69,"locationsCount":72},"100616297","phase-2-efficacy-safety-and-poppk-profile-of-abp-745-in-patients-with-atherosclerosis-100616297","NCT07303777","Efficacy, Safety, and PopPK Profile of ABP-745 in Patients With Atherosclerosis","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy, Safety, and Population Pharmacokinetics (PopPK) Profile of ABP-745 in Patients With Atherosclerosis","Inclusion Criteria:\n\nUnless otherwise specified, subjects must meet all of the following criteria at screening:\n\n* Diagnosed with coronary at herosclerosis, and coronary angiography.\n* Male or female at 18-75 years of age (inclusive).\n* Weight ≥40 kg.\n* Currently using any oral lipid-lowering therapy.\n* Able to understand and willing to sign an ICF and comply with study requirements.\n* A woman or man of childbearing potential agreeing to use medically approved contraceptive methods from the screening until 3 months after the last study dose.\n\nExclusion Criteria:\n\nUnless otherwise specified, subjects are excluded from the study if any of the following criteria is met:\n\n* History of stroke within the past 6 months.\n* Uncontrolled arrhythmia within 3 months prior to screening.\n* Evidence of any active or suspected cancer within 3 years prior to the screening.\n* Having undergone any major surgery within 3 months prior to the screening or planning to undergo any major surgery during the study.\n* Presence or suspicion of ongoing of any serious infection.\n* Human immunodeficiency virus (HIV) infection.","75 Years",{"count":56,"type":20},200,[23],"This is a multicenter, randomized, double-blind, placebo parallel controlled study to evaluate the preliminary efficacy, safety, and PopPK profile of ABP-745 in patients with ASCVD. Efficacy of ABP-745 in reducing atherosclerotic plaque compared with placebo will be evaluated in participants with ASCVD. The primary efficacy measurement will be assessed at 52W of treatment.",[60,27,28],"Atherosclerosis Cardiovascular Disease",[27,62],"ABP-745","2026-04-23",{"date":65,"type":38},"2026-04-28",{"date":63,"type":38},{"date":68,"type":20},"2028-04",{"name":70,"class":71},"Atom Therapeutics Co., Ltd","INDUSTRY",33,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":83,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":99,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100630769","development-and-multicenter-validation-of-an-ai-based-remote-photoplethysmography-rppg-facial-scan-for-multimodal-health-assessment-100630769","NCT07491978","Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment","Development and Multicenter Validation of an AI-Based Remote Photoplethysmography (rPPG) Facial Scan for Multimodal Health Assessment: Agreement With Clinical, Laboratory, and Psychological Parameters in an Urban Population","Inclusion Criteria:\n\n1. Adults aged ≥18 years.\n2. Able and willing to provide written informed consent.\n3. Able to comply with study procedures, including face scan, physical examination, blood sampling, and questionnaire completion.\n4. Clinically stable at the time of assessment.\n\nExclusion Criteria:\n\n1. Facial conditions affecting the region of interest (ROI), such as injury, deformity, or impaired circulation, that may interfere with rPPG signal acquisition.\n2. Presence of facial tattoos or coverings that obstruct optical signal detection.\n3. Inability to remain still or comply with measurement procedures during data acquisition.\n4. Severe medical conditions that preclude safe participation, as judged by the investigator.\n5. Incomplete data or withdrawal of consent during the study.\n\n   \\-",true,{"count":82,"type":20},1000,"1 Day","OBSERVATIONAL","The goal of this observational study is to learn if a non-contact facial scan using artificial intelligence (AI) can be used to check health status in adults living in urban areas such as Jakarta. The facial scan uses a method called remote photoplethysmography (rPPG), which measures small changes in blood flow from the face using a camera.\n\nThe main questions this study aims to answer are:\n\n1. How close are the results from the facial scan to standard medical measurements, such as heart rate, breathing rate, blood pressure, and oxygen levels?\n2. Can the facial scan estimate other health indicators, such as blood sugar, lipid profile, HbA1c, and hemoglobin levels?\n3. Is there a relationship between the facial scan results and mental health, such as stress, anxiety, and depression?\n\nParticipants will take part in several simple and mostly non-invasive procedures:\n\n1. Answer questionnaires about their mental health and daily habits\n2. Have basic health checks, such as blood pressure, heart rate, and body measurements\n3. Provide a blood sample for laboratory testing\n4. Complete a facial scan using a camera for about 1 to 3 minutes\n\nResearchers will compare the results from the facial scan with standard clinical and laboratory tests to see how well the technology works.\n\nThis study may help develop a simple and accessible screening tool that can be used for early detection of health risks. It may also support the use of digital health and telemedicine in community and clinical settings.",[87,88,89,90,27,91,92,93,94,95,96,97,98],"Metabolic Syndrome","Hypertension","Diabetes (DM)","Tachycardia","Depression Disorder","Anxiety","Stress (Psychology)","Obesity & Overweight","Cardiometabolic Risk Factors","Cardiometabolic Health Indicators","Sleep","Wellness",[100,101,102,103,104,105,106,107,108,109],"remote photoplethysmography","rPPG","artificial intelligence","digital biomarker","telemedicine","vital signs","cardiometabolic risk","machine learning","facial scan","screening tool","NOT_YET_RECRUITING","2026-04-15",{"date":113,"type":38},"2026-04-20",{"date":115,"type":20},"2026-04-24",{"date":117,"type":20},"2027-03-30",{"name":119,"class":45},"Tarumanagara University",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":128,"targetDuration":4,"studyType":21,"phases":130,"briefSummary":132,"conditions":133,"keywords":135,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":143,"completionDateStruct":145,"leadSponsor":147,"locationsCount":46},"100633127","adherence-to-dyslipidemia-therapy-harnessing-evidence-from-randomized-evaluations-in-atherosclerotic-cardiovascular-disease-100633127","NCT07522645","Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease","Adherence to Dyslipidemia Therapy: Harnessing Evidence From Randomized Evaluations in AtheroSclerotic CardioVascular Disease (ADHERE-ASCVD)","ADHERE-ASCVD","Inclusion Criteria\n\n1. Age ≥18 years\n2. Active Kaiser Permanente Northern California (KPNC) membership\n3. Diagnosis of atherosclerotic cardiovascular disease (ASCVD) or diabetes and inclusion in the Preventing Heart Attacks and Strokes Everyday (PHASE) Registry\n4. No statin prescription fill within the prior 3 months\n5. Statin adherence \\\u003C80% in the prior 12 months\n6. Active kp.org account within the past 12 months\n7. Valid email address and text-capable phone number on file\n\nExclusion Criteria\n\n1. Documented allergic reaction or contraindication to statin therapy\n2. Receiving hospice care\n3. Medicare beneficiaries\n4. Other exclusions applied per operational standard practice",{"count":129,"type":20},22000,[131],"NA","The goal of the ADHERE-ASCVD study is to evaluate and optimize patient-facing messaging strategies to improve statin refill and adherence among adults with atherosclerotic cardiovascular disease (ASCVD) or diabetes.\n\nThe main questions it aims to answer are:\n\n1. Do different outreach methods (such as text messages, secure portal messages, or email) increase short-term statin refill compared to usual care?\n2. Among patients who do not initially refill their prescription, does changing the outreach method improve refill rates?\n\nThe team with operational partners will evaluate the comparitive effectivessness of multiple messaging strategies delivered through existing health system communication channels, including SMS (text messaging), secure patient portal messages, non-secure email, and usual care (no additional outreach).\n\nParticipants\n\n* Receive an initial outreach message encouraging statin refill (or usual care) Be monitored for statin refill within 14 days\n* Potentially receive a second outreach message using the same or a different communication method if they do not initially refill their prescription\n* Have their medication refill patterns tracked over time, including longer-term adherence outcomes",[27,134],"Diabetes",[27,33,136,137,138,139,140],"statin therapy","statin","SMART design","messaging strategies","patient outreach","2026-04-13",{"date":111,"type":38},{"date":144,"type":20},"2026-04-14",{"date":146,"type":20},"2028-12-31",{"name":148,"class":45},"Kaiser Permanente",{"id":150,"slug":151,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":155,"eligibilityCriteria":156,"healthyVolunteers":11,"sex":16,"minAge":157,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":21,"phases":161,"briefSummary":163,"conditions":164,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":166,"lastUpdatePostDateStruct":167,"startDateStruct":168,"completionDateStruct":170,"leadSponsor":172,"locationsCount":174},"100469291","phase-4-prevention-of-cardiovascular-and-diabetic-kidney-disease-in-type-2-diabetes-100469291","NCT05390892","PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes","PRECIDENTD: PREvention of CardIovascular and DiabEtic kidNey Disease in Type 2 Diabetes","PRECIDENTD","Inclusion Criteria:\n\n* Type 2 diabetes based on clinical diagnosis\n* HbA1c ≥6% measured within 12 months prior to screening\n* Secondary prevention cohort (at least 70% of cohort):\n\n  * Age 40 to 80 years\n  * Evidence of established atherosclerotic cardiovascular disease (ASCVD), as defined by one or more of the following\n  * Coronary heart disease defined by at least one of the following: prior myocardial infarction, prior coronary percutaneous coronary intervention, ≥50% stenosis of a coronary artery documented by invasive or non-invasive imaging (including CT coronary angiography), positive stress test, or coronary artery calcium score \\>400 Agatston units;\n  * Cerebrovascular disease defined by at least one of the following: prior ischemic stroke, prior carotid revascularization procedure, carotid stenosis ≥ 50% documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound;\n  * Symptomatic peripheral artery disease defined by at least one of the following: leg symptoms with an ABI ≤ 0.9, leg symptoms with imaging evidence of a stenosis ≥50% in a peripheral artery documented by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound, or prior amputation for atherosclerotic disease.\n* Primary prevention cohort (capped at 30% of cohort):\n\n  * Age 60-80 years and at least 1 additional high-risk feature:\n  * Cardiovascular risk factors\u002Fhigh-risk features:\n  * Active smoking (combustible tobacco or marijuana)\n  * HbA1c ≥ 8% measured within 12 months prior to screening. The most recent value available at the time of screening will be used for screening and to determine eligibility.\n  * Stage 3a CKD, eGFR 45-59 ml\u002Fmin\u002F1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.\n* Willingness to be randomly assigned to medication class (SGLT2i or GLP-1 RA or both) and fill prescription through personal pharmacy benefit while having other medications adjusted for safety\n* Willingness to avoid starting a therapy in the alternative treatment group (e.g., if randomized to GLP-1 RA, avoid starting an SGLT2i) unless strongly recommended by the participant's usual care provider.\n* If taking one of the study medication classes, willingness to stop SGLT2i or GLP-1 RA and be randomly assigned to one of the two medication classes\n* Willingness to consent to data collection using the electronic health record and sign a medical release to obtain future medical records from other health care facilities\n\nExclusion Criteria:\n\n* Known or suspected diabetes of other cause (type 1 diabetes, pancreatogenic diabetes, monogenic diabetes, etc.)\n* Any background diabetes medication regimen will be allowed in this pragmatic trial with the following proviso:\n\n  o Participants taking basal-bolus, prandial, or multiple daily injection insulin (MDI) regimens (e.g., short-acting in combination with long-acting insulin, called MDI regimens) are eligible only if the research staff attests that there has been communication with the usual diabetes care provider and that the provider has agreed to manage insulin adjustment with initiation of study medications. If such agreement has not been obtained, participants taking MDI regimens are excluded.\n* History of diabetic ketoacidosis\n* Active diabetic foot ulcer\n* History of pancreatitis\n* Heart failure as a primary reason for hospitalization within the past year\n* Known left ventricular ejection fraction \\\u003C40%\n* Known urinary albumin-to-creatinine ratio \\>200 mg\u002Fg at screening\n* Estimated glomerular filtration rate (eGFR) less than 45 ml\u002Fmin\u002F1.73m2 measured within 12 months prior to screening. The most recent value available at screening will be used for screening and to determine eligibility.\n* Known inability to afford study medication through current insurance coverage.\n* If a woman of child-bearing potential, the patient or partner is unwilling to use birth control\n* Active treatment for cancer, planned treatment for cancer, or recent active cancer with likelihood of recurrence or progression, which, in the opinion of the site investigator, has a likelihood of recurrence that would interfere with study therapy prior to 2028\n\n  * Treated cancer with no evidence of disease, no evidence of disease progression, and no planned change in therapy is allowed. Examples of allowable cancers include:\n  * Breast cancer stable after active treatment, managed with long-term anti-estrogen therapy\n  * Prostate cancer being observed\n  * Stage 0 or 1 tumors status post resection or other definitive treatment\n  * Other similarly stable cancer comorbidities\n* History of solid organ or bone marrow transplant\n* Allergy to SGLT2 inhibitor or GLP-1 receptor agonist","40 Years","80 Years",{"count":160,"type":20},6000,[162],"PHASE4","PRECIDENTD is a randomized, open label, pragmatic clinical trial designed to compare rates of the total number of cardiovascular, kidney, and death events among two alternative treatments for patients with type 2 diabetes (T2D) and either established atherosclerotic cardiovascular disease (ASCVD) or at high risk for ASCVD. To accomplish this objective, we will randomly assign 6,000 patients with established T2D and ASCVD or high-risk for ASCVD in a 1:1 allocation to sodium-glucose cotransporter-2 inhibitor (SGLT2i) or glucagon-like peptide-1 receptor agonists (GLP-1RA). Participants will be followed for the occurrence of the trial primary endpoint of the total (first and recurrent) number of episodes of myocardial infarction (MI), stroke, arterial revascularization, hospitalization for heart failure, development of end-stage kidney disease, kidney transplantation, and mortality, counting all events from randomization until end of study.",[165,27],"Type2Diabetes","2026-04-07",{"date":141,"type":38},{"date":169,"type":38},"2022-09-26",{"date":171,"type":20},"2029-03-01",{"name":173,"class":45},"Brigham and Women's Hospital",36,{"id":176,"slug":177,"hasResults":11,"nctId":178,"briefTitle":179,"officialTitle":180,"acronym":181,"eligibilityCriteria":182,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":183,"targetDuration":4,"studyType":21,"phases":185,"briefSummary":186,"conditions":187,"keywords":189,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":46},"100601991","duke-cardiometabolic-prevention-clinics-impact-on-high-risk-cardiovascular-patients-with-uncontrolled-risk-factors-100601991","NCT07117695","Duke Cardiometabolic Prevention Clinic's Impact on High-risk Cardiovascular Patients With Uncontrolled Risk Factors","Efficacy of Multidisciplinary Prevention Clinic Model for Cardiovascular Risk Reduction in High Risk Patients","DUKE PREVENT","Inclusion Criteria:\n\n1. Adults ≥ 18 years of age\n2. Prior history of cardiovascular disease (prior history of CAD, MI, ischemic stroke, PVD, any arterial revascularization)\n3. Type 2 Diabetes\n4. Uncontrolled sBP AND LDL-C within the preceding 3 months:\n\n   * SBP \\> 150mmHg on at least 1 occasion in last 3 months, AND\n   * LDL \\> 130mg\u002FdL in last 3 months\n\n     * NOTE: If there are not enough patients with the above inclusion criteria available for enrollment, then we will expand the criteria to include patients with uncontrolled sBP and LDL-C within the last 6 months.\n\nExclusion Criteria:\n\n1. Currently or previously established with providers in the Duke Cardiometabolic Prevention Clinic (Pagidipati, Shah, McGarrah, Blazing, Kelsey)\n2. History of advanced dementia\n3. Referred to hospice\u002Fon hospice\n4. Lives outside of Durham County, Orange County, Wake County, Person County or Granville County\n5. End Stage Renal Disease (those on dialysis or with EGFR \\\u003C20)\n6. History of cardiac transplant\u002FListed for Cardiac Transplant\u002FFollowed by Advanced Heart Failure\n7. Pregnant\u002FPlanning to become pregnant during study period",{"count":184,"type":20},150,[131],"This project is studying whether a team-based specialty clinic can help people with type 2 diabetes and heart disease better manage their blood pressure and cholesterol. The clinic includes coordinated care from heart doctors, kidney doctors, diabetes specialists, and liver doctors.\n\nThe study will compare two groups of patients: one receiving usual care from their primary care provider, and one referred to the Duke Cardiometabolic Prevention Clinic for multidisciplinary care. The main goals are to find out if this clinic improves blood pressure and cholesterol control over 12 months, increases use of recommended heart medications, and reduces hospital visits and other healthcare use.\n\nParticipants will be randomly assigned to one of the two groups. Those referred to the clinic will: 1) Meet with a cardiologist for an initial evaluation. 2) Be referred to other specialists (such as endocrinology, nephrology, or hepatology) based on their needs. 3) Receive ongoing, coordinated care from a team of specialists working together to improve their heart and metabolic health.",[27,188,88],"Hyperlipidemia",[27,190,191,88,188],"Cardiometabolic Clinic","Prevention","2026-02-23",{"date":194,"type":38},"2026-02-24",{"date":196,"type":20},"2026-06-02",{"date":198,"type":20},"2027-12-27",{"name":200,"class":45},"Duke University",{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":157,"maxAge":4,"enrollmentInfo":208,"targetDuration":210,"studyType":84,"phases":4,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":213,"lastUpdatePostDateStruct":214,"startDateStruct":216,"completionDateStruct":218,"leadSponsor":220,"locationsCount":46},"100613768","the-long-term-effect-of-remote-ischemic-conditioning-on-main-organs-in-asvcd-patients-with-very-high-risks-100613768","NCT07270887","The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks","The Long-term Effect of Remote Ischemic Conditioning on Main Organs in ASVCD Patients With Very High Risks (RICMO-ASCVD): a Prospective, Blinded Endpoint, Multi-center, Cohort Study","Inclusion Criteria:\n\n* Age over 40 years\n* Two or more prior major ASCVD events; OR one documented major ASCVD event with two or more of the following risk factors\n* signed informed consent\n\nNote： Definition of Major ASCVD Events:\n\nA. Acute coronary syndrome within the past year. B. History of myocardial infarction (not part of a new acute coronary syndrome episode).\n\nC. Ischemic stroke or history of ischemic stroke. D. Symptomatic peripheral artery disease, defined as intermittent claudication with an ankle-brachial index (ABI) \\\u003C 0.85, or prior limb revascularization or amputation.\n\nRisk factors:\n\n1. Age ≥65 y\n2. Heterozygous familial hypercholesterolemia\n3. History of prior coronary artery bypass surgery or percutaneous coronary intervention outside of the major\n4. ASCVD event(s)\n5. Diabetes mellitus\n6. Hypertension\n7. CKD (eGFR 15-59 mL\u002Fmin\u002F1.73 m2)\n8. Current smoking\n9. Persistently elevated LDL-C (LDL-C ≥100 mg\u002FdL \\[≥2.6 mmol\u002FL\\]) despite maximally tolerated statin therapy and ezetimibe\n10. History of congestive HF\n\nExclusion Criteria:\n\n* Presence of severe neurological deficit (mRS score ≥ 3)\n* Uncontrolled severe hypertension (systolic blood pressure \\> 180 mmHg or diastolic blood pressure \\> 110 mmHg despite medication)\n* Subclavian artery stenosis ≥ 50% or presence of subclavian steal syndrome\n* Severe hematological disorders or significant coagulation abnormalities\n* Contraindications to remote ischemic conditioning, such as severe soft tissue injury, fracture, or vascular injury in the upper limbs, or peripheral vascular disease in the distal upper limbs\n* Severe comorbid conditions with a life expectancy of less than 1 year\n* Participation in another clinical trial within the past 3 months or ongoing participation\n* Any other circumstances deemed by the investigator as unsuitable for participation in this clinical study.",{"count":209,"type":20},2800,"1 Year","Atherosclerotic cardiovascular disease (ASCVD) is a group of disorders sharing atherosclerosis as a common pathological basis, primarily affecting the heart, brain, kidneys, and other peripheral arteries, leading to clinical syndromes characterized mainly by arterial ischemia. It has become the group of diseases with the highest morbidity and mortality rates worldwide. Patients with very high-risk ASCVD face an even greater risk of recurrence. Previous studies have discovered that remote ischemic conditioning (RIC) has protective effects on major organs such as the heart, brain, and kidneys. Given the cardiorenal and cerebrovascular protective effects of RIC, the invesitgators believe that long-term remote ischemic conditioning is a promising approach to preventing the recurrence of ASCVD events. Based on this hypothesis, the investigators have designed a prospective, multicenter cohort study with blinded outcome assessment to investigate the protective effects of long-term remote ischemic conditioning in very high-risk ASCVD populations.",[27],"2025-11-26",{"date":215,"type":38},"2025-12-08",{"date":217,"type":38},"2025-11-19",{"date":219,"type":20},"2027-12-30",{"name":221,"class":45},"General Hospital of Shenyang Military Region",{"id":223,"slug":224,"hasResults":11,"nctId":225,"briefTitle":226,"officialTitle":227,"acronym":228,"eligibilityCriteria":229,"healthyVolunteers":80,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":21,"phases":232,"briefSummary":233,"conditions":234,"keywords":236,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":46},"100552280","test-2-treat-can-we-improve-the-testing-and-treatment-of-high-cholesterol-in-patients-who-have-been-hospitalized-for-a-cardiac-event-by-providing-education-to-doctors-and-patients-100552280","NCT06471036","Test 2 Treat: Can we Improve the Testing and Treatment of High Cholesterol in Patients Who Have Been Hospitalized for a Cardiac Event by Providing Education to Doctors and Patients?","Test 2 Treat: A Randomized Implementation Trial to Improve LDL-C Management After Hospitalization for ASCVD (Atherosclerotic Cardiovascular Disease)","T2T","Inclusion Criteria:\n\n1. Age ≥ 18 years old\n2. Admitted with Type 1 NSTEMI or STEMI, and\u002For percutaneous coronary revascularization\n3. LDL-C level during admission ≥ 70 mg\u002FdL\n4. Primary care clinician and\u002For cardiologist within the health system (and with access to the same EHR) who will manage the patient in the outpatient setting\n\nExclusion Criteria:\n\n1. Determined to be highly unlikely to survive and\u002For to continue follow-up in that health system for at least 6 months (including those on hospice or with significant dementia), as identified by site investigator\n2. Underwent CABG (would therefore be discharged from surgical service)",{"count":231,"type":20},400,[131],"The goal of this implementation trial is to learn if providing education to doctors and patients who have had a heart event works to prevent future heart problems. The main questions it aims to answer are:\n\n1. Does educating the doctors in a health system improve how often patients in the hospital for a heart event have their cholesterol checked?\n2. Can a \"care champion\" who calls patients who have been discharged from the hospital after a heart event help patients to achieve their cholesterol goals?\n\nResearchers will compare the number of people who achieve their cholesterol goals with the help of the care champion to the number of people who did so without the intervention to see if the care champion works to help patients lower their cholesterol.\n\nParticipants will:\n\nComplete two 15 minute surveys over the phone - 1 at enrollment and 1 at the end of the study 6 months later.",[27,235],"LDL-C",[237,238,239,240,241],"Implementation Science","atherosclerotic cardiovascular disease (ASCVD)","low-density lipoprotein cholesterol (LDL-C)","Intervention","care champion","2025-07-22",{"date":244,"type":38},"2025-07-25",{"date":246,"type":38},"2024-10-08",{"date":248,"type":20},"2027-02-28",{"name":200,"class":45},{"id":251,"slug":252,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":4,"eligibilityCriteria":256,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":257,"targetDuration":4,"studyType":21,"phases":259,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":46},"100575091","phase-4-comparison-of-pitavastatin-plus-ezetimibe-versus-high-intensity-statin-therapy-on-risk-of-new-onset-diabetes-mellitus-100575091","NCT06767774","Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus","Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus in Prediabetic Patients With Atherosclerotic Cardiovascular Disease","Inclusion Criteria:\n\n* Age Requirement:\n\n  * Patients aged 18 years or older.\n\nGlycemic Status:\n\n* Patients who are not taking oral hypoglycemic agents (OHAs) and meet all of the following criteria:\n\n  * Fasting glucose less than 126 mg\u002FdL.\\*\n  * HbA1c less than 6.5%.\n  * Plasma glucose less than 200 mg\u002FdL after 2 hours during a 75 g oral glucose tolerance test (OGTT).\\*Note: For fasting glucose, two measurements of 126 mg\u002FdL or greater within 3 months are required for a diagnosis of diabetes.\n\nCardiovascular Disease:\n\n* Patients with established atherosclerotic cardiovascular disease, defined as having at least one of the following:\n\n  * Coronary Heart Disease (CHD):\n\n    * Documented history of myocardial infarction (MI).\n    * History of coronary revascularization.\n\n      * 50% stenosis of a major epicardial coronary artery confirmed by cardiac catheterization, computed tomography (CT), or coronary angiography.\n  * Cerebrovascular Disease:\n\n    \\>History of stroke of atherosclerotic origin.\n    * History of carotid revascularization.\n\n      \\>≥50% stenosis of the carotid artery confirmed by X-ray angiography, magnetic resonance (MR) angiography, CT angiography, or Doppler ultrasound.\n  * Symptomatic Peripheral Arterial Disease (PAD):\n\n    \\>Intermittent claudication with an ankle-brachial index (ABI) of 0.90 at rest.\n    * Intermittent claudication with ≥50% stenosis of a peripheral artery (excluding the carotid artery) confirmed by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound.\n    * History of revascularization of peripheral arteries (excluding carotid arteries).\n    * Lower extremity amputation at or above the ankle due to atherosclerotic disease (excluding trauma or osteomyelitis).\n\nDietary Requirements:\n\n* Patients must be on a stable diet prior to randomization and able to adhere to the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Change (TLC) diet or an equivalent throughout the study.\n\nInformed Consent:\n\n* Subjects or their legal representatives must provide written informed consent to the study protocol and clinical follow-up schedule.\n* An informed consent form approved by the institutional review board (IRB)\u002Fethics committee of the study site must be signed.\n\nExclusion Criteria:\n\n* Patient is pregnant or breastfeeding or of childbearing potential.\n* Requires concomitant administration of strong inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins).\n* Chronic kidney disease (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m²) or dialysis-dependent renal failure.\n* Uncontrolled hypothyroidism.\n* Personal or family history of an inherited muscle disorder.\n* History of statin-induced muscle toxicity.\n* Alcohol-dependent person.\n* Hypersensitivity to statins and ezetimibe.\n* Hemodynamic instability at the time of enrollment: cardiogenic shock, refractory ventricular arrhythmia, or congestive heart failure (New York Heart Association class IV) at randomization.\n* History of hemorrhagic stroke or intracranial hemorrhage, TIA, or ischemic stroke within the past 6 months.\n* Planned surgery requiring discontinuation of statins or ezetimibe within 6 months of randomization.\n* Current treatment for active cancer.\n* Clinically significant abnormal findings identified at the screening visit, physical examination, laboratory tests, or electrocardiogram that, in the investigator's judgment, may interfere with safe completion of the study.\n* Liver disease or biliary obstruction, elevated liver enzymes (ALT or AST \\> the upper limit of normal) or elevated total bilirubin (total bilirubin \\> 2 times the upper limit of normal) at screening.\n* Life expectancy for noncardiac or cardiac causes \\\u003C 1 year.\n* Unwillingness or inability to comply with the procedures described in this protocol.\n* Previously diagnosed with diabetes mellitus and compliant with lifestyle modification and taking oral hypoglycemic agents (OHAs) or insulin.",{"count":258,"type":20},2000,[162],"The AVOID-DM trial is a multicenter, prospective, randomized study comparing the risk of new-onset diabetes mellitus (DM) between two cholesterol-lowering strategies in patients with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). The study evaluates pitavastatin plus ezetimibe combination therapy versus high-intensity statin monotherapy (rosuvastatin 20 mg). Enrolling 2,000 non-diabetic participants with ASCVD, subjects are randomized 1:1 into the two treatment arms. The primary outcome is the incidence of new-onset DM over a follow-up period of up to 36 months. Secondary outcomes include cardiovascular events, changes in LDL cholesterol, fasting glucose, HbA1c, and insulin resistance. This trial hypothesizes that the combination therapy will achieve LDL targets with a lower risk of new-onset DM compared to high-intensity statin monotherapy.",[27,134,262],"Statin","2025-04-24",{"date":265,"type":38},"2025-04-27",{"date":267,"type":38},"2025-04-25",{"date":269,"type":20},"2030-01-31",{"name":271,"class":45},"Korea University Anam Hospital",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":4,"eligibilityCriteria":278,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":279,"targetDuration":4,"studyType":21,"phases":281,"briefSummary":283,"conditions":284,"keywords":291,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":303},"100559771","phase-3-a-study-on-efficacy-and-safety-of-hst101-in-chinese-patients-with-hypercholesterolemia-100559771","NCT06568471","A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia","A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia","Inclusion Criteria:\n\n* Provision of written and signed informed consent form prior to any study-specific procedure;\n* Male or female participants ≥18 years of age at the screening visit;\n* Body weight ≥ 40 kg and body mass index (BMI) ≥18 and ≤35 kg\u002Fm2;\n* On a stable diet and lipid-lowering oral drugs (such as statins, ezetimibe or Hybutimibe, omega-3 compounds, fenofibrate, nicotinic acid, etc.) for at least 4 weeks prior to the first drug administration\n* LDL-C≥1.8 mmol\u002FL (70 mg\u002FdL) and TG≤4.52 mmol\u002FL (400 mg\u002FdL) at screening for ASCVD patients or those at very (ultra)-high risk for ASCVD, including patients with HeFH; LDL-C ≥ 2.6 mmol\u002FL (100 mg\u002FdL) and TG ≤ 4.52 mmol\u002FL (400 mg\u002FdL) at screening for patients at high-risk for ASCVD including patients with HeFH;\n* Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥6 weeks after the last dose; for those on 300 mg or 420 mg Q4W, the washout period is ≥10 weeks following last dose;\n* Female of childbearing potential must have a negative pregnancy test at the last screening visit and consent to use highly effective contraceptives during the trial and 3 months after the last dose of investigational drug.\n\nExclusion Criteria:\n\n* Documented history of homozygous familial hypercholesterolemia (HoFH);\n* Estimated glomerular filtration rate (eGFR)\\\u003C30 mL\u002Fmin\u002F1.73m2;\n* Active liver disease or hepatic dysfunction, history of liver transplant, and\u002For ALT or AST \\>2.5 × ULN at screening;\n* Poorly controlled thyroid disorder including hypothyroidism or hyperthyroidism;\n* Poorly controlled Type 1 or Type 2 diabetes mellitus defined as fasting blood glucose ≥11.0 mmol\u002FL (200 mg\u002FdL) and glycosylated hemoglobin (HbA1c) ≥ 9%;\n* Serious arrhythmia, MI, unstable angina pectoris, PCI, CABG, implantable cardioverter defibrillator, aortic valve surgery or stroke within 3 months prior to the first dose;\n* Planned cardiac surgery or revascularization during the study period;\n* New York Heart Association (NYHA) Class III-IV heart failure;\n* Pregnant or lactating women;\n* Poorly controlled hypertension (SBP≥160 mmHg or DBP≥100 mmHg in a sitting position)\n* Unexplained creatine kinase (CK) \\> 5 x ULN (retested once is needed if suspected to be related to excessive exercise or abnormal activity);\n* LDL apheresis or plasma exchange within 2 months prior to the first dose;\n* HIV, Treponema pallidum, or HCV antibody test positive, or HBV-DNA \\>ULN at screening;\n* History of prescription drug abuse, illicit drug use or alcohol abuse within 6 months prior to screening;\n* History of any major drug allergy, including allergy to protein biologics;\n* Participate another clinical trial within 30 days or less than 5 half-lifes (drug) before screening, whichever is longer",{"count":280,"type":20},210,[282],"PHASE3","This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W \\[≤31 days\\]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high\u002Fhigh risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.",[285,286,287,288,289,290,27],"Hypercholesterolemia","Dyslipidemias","Primary Hypercholesterolemia","Heterozygous Familial Hypercholesterolemia","Hyperlipidemia; Mixed","Metabolic Disease",[292,293,235],"PCSK9 inhibitor","Lerodalcibep","2025-02-04",{"date":296,"type":38},"2025-02-06",{"date":298,"type":38},"2024-11-16",{"date":300,"type":20},"2026-05",{"name":302,"class":71},"Hasten Biopharmaceutical Co., Ltd.",18,{"id":305,"slug":306,"hasResults":11,"nctId":307,"briefTitle":308,"officialTitle":309,"acronym":4,"eligibilityCriteria":310,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":54,"enrollmentInfo":311,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":312,"conditions":313,"keywords":4,"overallStatus":110,"whyStopped":4,"lastUpdateSubmitDate":315,"lastUpdatePostDateStruct":316,"startDateStruct":318,"completionDateStruct":320,"leadSponsor":322,"locationsCount":4},"100565398","npc1l1-gene-polymorphism-and-the-efficacy-and-safety-of-hybutimibe-100565398","NCT06641661","NPC1L1 Gene Polymorphism and the Efficacy and Safety of Hybutimibe","The Association Between NPC1L1 Gene Polymorphism and the Efficacy and Safety of Hybutimibe in High\u002Fvery High Risk ASCVD Patients","Inclusion Criteria:\n\n1. Patients with high\u002Fvery high risk of ASCVD were only treated with moderate intensity statins (including atorvastatin 10-20mg, rosuvastatin 5-10mg, fluvastatin 80mg, lovastatin 40mg, pivastatin 1-4mg, pravastatin 40mg, simvastatin 20-40mg, etc.) for at least 8 weeks before enlistment.\n2. The LDL-C level did not meet the lipid reduction target corresponding to the risk stratification level of ASCVD recommended by the Chinese Lipid Management Guidelines (2023), or the level of LDL-C was still not up to the standard as clinicians expected that patients should continue to use medium-dose statins for lipid-lowering treatment alone, and the cholesterol absorption inhibitor Hybomab should be combined;\n3. Age 18-75 years old;\n4. BMI range 22-45 kg\u002Fm2;\n5. Can understand and voluntarily sign informed consent.\n\nExclusion Criteria:\n\n1. Allergic history of cholesterol absorption inhibitors and statins;\n2. other types of cholesterol absorption inhibitors have been used;\n3. Homozygous familial hypercholesterolemia;\n4. any clinically serious endocrine disease affecting blood lipids or lipid proteins;\n5. Abnormal liver function with AST or ALT greater than three times the upper limit of normal, or bilirubin \\>34uM, creatine muscle enzyme greater than five times the upper limit of normal, or evidence of serologically infectious liver disease;\n6. Thyroid dysfunction;\n7. History of malignant tumor;\n8. Patients with coagulation dysfunction;\n9. Women who are pregnant or planning to become pregnant;\n10. Taking fenofibrate, gefilozil, probucol, warfarin, glucocorticoids, cyclosporine or another immunosuppressant within 30 days prior to the trial;\n11. can not adhere to medication or regular follow-up;\n12. Communication disorders, people with severe aphasia, audio-visual impairment, serious mental illness, and difficulty cooperating with investigators;\n13. There are other circumstances that the researcher considers inappropriate to participate in this study.",{"count":82,"type":20},"Significant individual differences may lead to differences in patients' responses to drug therapy and lead to an increased incidence of adverse reactions. However, there are currently very limited data on the genetic variation of the NPC1L1 gene in the Chinese population. In view of the important role of NPC1L1 gene polymorphism in cholesterol absorption, lipid profile, coronary heart disease prevalence and ezetimibe response, it is necessary to focus on the allele frequency analysis of NPC1L1 gene polymorphism in the Chinese population, and to further explore the therapeutic response of NPC1L1 gene polymorphism and Hybutimibe.\n\nWith reference to previous domestic and foreign literature reports and HapMap project (http:\u002F\u002Fhapmap.ncbi.nlm. nih.gov\u002F)SNP) distribution, this study selected NPC1L1 gene loci with relatively in-depth clinical research. rs2072183, rs4720470, rs2073547 were analyzed. The minimum allele frequency (MAF) of the above loci were all greater than 10%, and it has been confirmed that genetic variation exists between different diseases and different races, which may affect the lipid profile , the risk of coronary heart disease and the response to hybomaib treatment. However, the variability of rs2072183 in response to Hybutimibe needs to be further verified, and the effects of rs4720470 and rs2073547 gene polymorphisms on drug response also need to be targeted. In order to further determine the correlation between the distribution of NPC1L1 polymorphism and the efficacy and safety of Hybutimibe, we conducted this study to observe the distribution frequency of NPC1L1 gene polymorphisms at rs2072183, rs4720470 and rs2073547 in high-risk\u002Fextremely high-risk ASCVD patients. To explore the correlation between NPC1L1 gene polymorphisms and the efficacy and safety of Hybutimibe combined with moderate-intensity statins in the treatment of high-risk\u002Fvery high-risk ASCVD patients. This is the first time to explore the distribution of NPC1L1 polymorphism in high\u002Fvery high risk ASCVD population in China, which will provide genetic evidence for the correct use of Hybutimibe and moderate intensity statin therapy, and provide further evidence-based medical evidence for the distribution of NPC1L1 polymorphism and the efficacy and safety of Hybutimibe.",[314,27],"Gene Polymorphism","2024-10-11",{"date":317,"type":38},"2024-10-15",{"date":319,"type":20},"2024-11-01",{"date":321,"type":20},"2027-06",{"name":323,"class":45},"Qianfoshan Hospital"]