[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"premature-atherosclerosis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:premature-atherosclerosis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,47],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100473094","phase-2-the-role-of-anifrolumab-in-improving-markers-of-vascular-risk-in-patients-with-systemic-lupus-erythematosus-sle---ifn-cvd-100473094",false,"NCT05440422","The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus (SLE) - IFN-CVD","The Role of Anifrolumab in Improving Markers of Vascular Risk in Patients With Systemic Lupus Erythematosus","* INCLUSION CRITERIA:\n\nIn order to be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Provision of signed and dated informed consent form\n2. Stated willingness to comply with all study procedures and availability for the duration of the study\n3. Male or female, aged 18-80 years\n4. In good general health as evidenced by medical history or diagnosed with SLE diagnosed per American College of Rheumatology 1997 revised SLE classification criteria.\n5. Prednisone \\\u003C or equal to 10 mg\u002Fday for at least 2 weeks before screening and maintained throughout randomization (day 1)\n6. Stable standard of care lupus therapies for at least 4 weeks before screening and maintained through randomization (day 1)\n7. Abnormal cardio-ankle vascular index (CAVI) (based on 2 SD above median of healthy controls based on historical data from our own patient cohorts AND\u002FOR\n8. Abnormal Pulse wave velocity (PWV) using Sphygmocor. AND\u002FOR\n9. Abnormal target to background ratio (TBR) in various aortic territories and total aorta using FDG PET CT scan.\n10. Stable medications for diabetes, hypertension and\u002For statins for at least the previous 3 months. No changes of these medications or immunosuppressive drugs will be allowed during trial.\n11. For females and males of reproductive potential: use of highly effective contraception from screening and agreement to use such a method during study participation and for an additional 16 weeks after the end of study medication administration. For the purpose of this study abstinence will be considered as an effective form of contraception.\n12. Subjects must confirm receipt of prior vaccination against COVID-19 and Varicella Zoster. Verbal confirmation of vaccination receipt AND detectable antibodies in serum is acceptable in the absence of vaccine records.\n\n    EXCLUSION CRITERIA:\n\n    An individual who meets any of the following criteria will be excluded from participation in this\n\n    study:\n    * Any condition that, in the opinion of the Investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results.\n    * Concurrent enrolment in another clinical study with an investigational product\n    * Major surgery within 8 weeks before signing the ICF or elective major surgery planned during the study period.\n    * Any of the following found at Screening:\n\n      * Aspartate aminotransferase (AST) \\>2.5 x upper limit of normal (ULN).\n      * Alanine aminotransferase (ALT) \\>2.0 x ULN.\n      * Total bilirubin \\>ULN (unless due to Gilbert's syndrome)\n      * Serum creatinine \\>2.5 mg\u002FdL (or \\>181 micromol\u002FL)\n      * Urine protein\u002Fcreatinine ratio \\>2.0 mg\u002Fmg (or \\>226.30 mg\u002Fmmol)\n      * Neutrophil count \\\u003C1000\u002FmicroL (or \\\u003C1.0 x 109\u002FL)\n      * Platelet count \\\u003C25000\u002FmicroL (or \\\u003C25 x 109\u002FL)\n      * Hemoglobin \\\u003C8 g\u002FdL (or \\\u003C80 g\u002FL), or \\\u003C7 g\u002FdL (or \\\u003C70 g\u002FL) if related to subject's SLE such as in active hemolytic anemia\n      * Glycosylated hemoglobin (HbA1c) \\>8% (or \\>0.08) at screening (diabetic subjects only)\n      * Positive SARS\u002FFlu A\u002FB\u002FRSV (Panther), PCR\n\n    Note: Abnormal screening test(s) which exclude the patient may be repeated once within 4 weeks of the Screening Visit. If the repeat test(s) does not meet the above criteria, then the patient may be included in the study and will not be considered a screen failure.\n    * Receipt of any of the following:\n\n      1. Azathioprine \\>200 mg\u002Fday\n      2. Mycophenolate mofetil \\> 3 g\u002Fday or mycophenolic acid \\>2.16 g\u002Fday\n      3. Oral, SC, or intramuscular methotrexate \\>25 mg\u002Fweek\n      4. Mizoribine \\>150 mg\u002Fday. Leflunomide more than 20 mg and any other immunosuppressant usage at the discretion of the PI.\n    * Receipt of any investigational product (small molecule or biologic agent) within 4 weeks or 5 half-lives prior to week 0 (day 1), whichever is greater.\n    * Receipt of any commercially available biologic agent within 5 half-lives prior to signing of the ICF\n    * Receipt of B cell depleting therapy (including but not limited to belimumab, ocrelizumab, ofatumumab, atacicept, Obinutuzumab, or rituximab), \\\u003C26 weeks prior to the signing of the consent for all B-cell depleting therapy or \\\u003C40 weeks prior to the signing of the ICF for atacicept.\n    * Receipt of any of the following: (a) Intra-articular, intramuscular or IV corticosteroids within 4 weeks prior to Day 1 (b) Any live or attenuated vaccine within 8 weeks prior to signing the ICF (administration of killed vaccines is acceptable)\n    * History or evidence of suicidal ideation within the past 6 months; or any suicidal behavior within the past 12 months based on screening or at baseline.\n    * Recent cardiac or stroke event (with in the last year prior to week 0 (day 1))\n    * Active SLE disease with SLEDAI 2K \\>6 at the time of screening.\n    * Active severe or unstable neuropsychiatric SLE including, but not limited to: aseptic meningitis; cerebral vasculitis; myelopathy; demyelination syndromes (ascending, transverse, acute inflammatory demyelinating polyradiculopathy); acute confusional state; impaired level of consciousness; psychosis; acute stroke or stroke syndrome; cranial neuropathy; status epilepticus; cerebellar ataxia; and mononeuritis multiplex:\n\n      1. That would make the subject unable to fully understand the ICF OR\n      2. Where, in the opinion of the Principal Investigator (PI), protocol specified SOC is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated\n    * Active severe SLE-driven renal disease where, in the opinion of the PI, protocol specified standard of care (SOC) is insufficient and utilization of a more aggressive therapeutic approach, such as adding IV cyclophosphamide and\u002For high dose IV pulse corticosteroid therapy or other treatments not permitted in the protocol, is indicated.\n    * History of or current diagnosis of catastrophic or severe anti-phospholipid syndrome within 1 year prior to signing the ICF. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 3 months is acceptable.\n    * Known history of a primary immunodeficiency, splenectomy, or any underlying condition that predisposes the subject to infection, or a positive result for human immunodeficiency virus (HIV) infection confirmed by central laboratory at screening. Subjects refusing HIV testing during the screening period will not be eligible for study participation.\n    * Confirmed positive test for hepatitis B serology for:\n\n      1. Hepatitis B surface antigen (HBsAg), OR\n      2. Hepatitis B core antibody (HBcAb)\n      3. If positive for HBcAb, hepatitis B virus (HBV) DNA will be checked. If HBV DNA is detected above the lower limit of quantitation (LLOQ) at screening subject will be excluded\n\n    Note: Subjects who are only HBcAb positive at screening will be tested every month for HBV DNA. To remain eligible for the study, the subject s HBV DNA levels must remain below the LLOQ as per the central laboratory.\n    * Positive test for hepatitis C antibody along with detectable Hepatitis C viral RNA.\n    * Any severe herpes infection at any time prior to Week 0 (Day 1), including, but not limited to, disseminated herpes (ever), herpes encephalitis (ever), recurrent herpes zoster (defined as 2 episodes within 2 years) or ophthalmic herpes (ever)\n    * Any herpes zoster, cytomegalovirus (CMV) or Epstein-Barr virus infection that has not completely resolved within 12 weeks prior to signing the ICF.\n    * Any of the following:\n\n      1. Clinically significant chronic infection (i.e., osteomyelitis, bronchiectasis, etc.) within 8 weeks prior to week 0 (day1) (chronic nail infections are allowed)\n      2. Any infection requiring hospitalization or treatment with IV antibiotics not completed at least 4 weeks prior to week 0 (day1)\n    * Any infection requiring oral antimicrobials (including antivirals) within 2 weeks prior to Day 1, except if taking antivirals\u002Fantimicrobials prophylactically.\n    * History of cancer, apart from:\n\n      1. Squamous or basal cell carcinoma of the skin treated with documented success of curative therapy \\>=3 months prior to Week 0 (Day 1)\n      2. Cervical cancer in situ treated with apparent success with curative therapy \\>=1 year prior to Week 0 (Day 1).\n    * Pregnancy or lactation or intend to become pregnant anytime from initiation of Screening until completion of study.\n    * Spontaneous or induced abortion, still or live birth, or pregnancy \\\u003C= 4 weeks prior to week 0 (day1)\n    * Known allergic reactions to any component of the investigational product formulation or history of anaphylaxis to any human gamma globulin therapy.\n    * Tested positive for COVID-19 infection on the day of screening or up to 21 days prior to screening.","ALL","18 Years","80 Years",{"count":20,"type":21},45,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","Background:\n\nPeople with systemic lupus erythematosus (SLE) are at risk of developing complications in their blood vessels. This can increase the risk of heart attacks or stroke. No medications have been effective at reducing this risk in people with lupus.\n\nObjective:\n\nTo test whether a drug (anifrolumab) can improve blood vessel function and reduce blood vessel inflammation in people with SLE.\n\nEligibility:\n\nPeople aged 18 to 80 years with SLE.\n\nDesign:\n\nParticipants will undergo screening. They will have a physical exam. They will have blood and urine tests. They will have a test of their heart function and a chest X-ray. They will answer questions about their SLE symptoms.\n\nParticipants will visit the clinic 9 times in 8 months. After screening, visits will be 4 weeks apart. Each visit may take up to 4 hours.\n\nParticipants will receive infusions from a tube attached to a needle inserted into a vein in the arm (IV). Some will receive anifrolumab. Others will receive a placebo treatment. They will not know which one they are getting.\n\nAt some visits they will have additional tests:\n\nCAVI (cardio-ankle vascular index) tests blood vessel function. Participants will lie still for 20 minutes. Small electrodes will be placed on both wrists with stickers. A microphone will be placed on their chest. Blood pressure cuffs will be wrapped around their ankles and arms.\n\nFDG-PET\u002FCT is an imaging procedure. Participants will receive a substance through an IV line. They will lie on a table for 110 minutes while a machine captures images of their body.",[27,28,29],"Systemic Lupus Erythematosus","Cardiovascular Disease","Premature Atherosclerosis",[31,32,33],"Vascular Inflammation","Interferons","Vascular Function","RECRUITING","2026-06-24",{"date":37,"type":38},"2026-06-25","ACTUAL",{"date":40,"type":38},"2023-12-07",{"date":42,"type":21},"2027-08-02",{"name":44,"class":45},"National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)","NIH",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":53,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":16,"minAge":55,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":66,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":4},"100610783","phase-3-pre-empt-prospective-randomized-evaluation-and-management-of-premature-atherosclerosis-100610783","NCT07232069","PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis","Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis","PRE-EMPT","Inclusion Criteria:\n\n1. Women aged 40-60 years; Men aged 30-50 years\n2. Willing and able to provide informed consent and comply with study procedures\n3. Smart phone user\n4. Use of highly effective contraception by females with reproductive potential.\n5. CAC score 1-99 in the screening study or entry through the known plaque pathway (with mild CAC or CAC\\\u003C100 if known; elevated CAC on baseline CCTA is not exclusionary in the known plaque arm)\n6. Diagnostic baseline CCTA with NCPV ≥10 mm3 as assessed by the central core lab\n\nExclusion Criteria:\n\n1. Clinical diagnosis of ASCVD including coronary artery disease (CAD), peripheral arterial disease (PAD) or cerebrovascular disease (CeVD)\n2. Current symptoms thought to be from CAD\n3. PREVENT ASCVD 10-year risk ≥5% (if known)\n4. Diabetes Mellitus (DM) as defined by any of the following: DM diagnosis in the medical record or HbA1C of 6.5% or greater. (if known)\n5. LDL-C ≥190mg\u002FdL (most recent, if known)\n6. HIV (if known)\n7. Severe liver disease or untreated Hepatitis C infection (if known)\n8. Pregnancy, lactation or intending to become pregnant during the study period of 2 years\n9. eGFR \\\u003C45mL\u002Fmin\u002F1.73m2 (if known)\n10. AST or ALT \\>1.5x the upper limit of normal (if known)\n11. BMI\\>40kg\u002Fm2 or unable to have a CCTA scan for any reason\n12. Allergy to iodinated intravenous contrast or other contraindication to CCTA\n13. Current or previous use of lipid lowering therapy or colchicine\n14. Known allergic reactions or sensitivity to the study intervention(s), including known intolerance or contraindication(s) to statin or colchicine, or long-term use of medications that are contraindicated with colchicine or rosuvastatin.\n15. Systemic cancer undergoing active treatment\n16. PREVENT ASCVD 10-year risk ≥5%\n17. eGFR \\\u003C45 ml\u002Fmin\u002F1.73m2 per baseline labs, (2021 CKD-EPI equation will be used if multiple options are available)\n18. Hemoglobin A1c ≥6.5% per baseline labs\n19. LDL-C ≥190mg\u002FdL per baseline labs\n20. Severe proximal coronary artery stenosis as determined by the central core lab (≥50% left main or ≥70% proximal major coronary artery stenosis)\n21. Known contraindication to follow-up CCTA (e.g., new IV contrast allergy discovered during the baseline CCTA)\n22. Individuals who are excluded based on any of these factors will be notified as to the reason for exclusion and encouraged to follow-up locally to address this medical issue with their treating physician.","30 Years","60 Years",{"count":58,"type":21},1500,[60],"PHASE3","Heart disease is the leading cause of death for men, women, and people of most racial and ethnic groups in the United States. This clinical trial will test if screening and early treatment of mild heart disease works.\n\nPRE-EMPT will screen individuals at low 10-year risk of heart disease with heart disease risk factors to identify those who already have early cholesterol build up, also called \"plaque\", in their heart arteries. It consists of two phases:\n\n1. A Screening Study - Participants will be assessed for plaque by one or both of these scans.\n\n   * Coronary Artery Calcium (CAC) Scan: A CT scan that looks for calcium or plaque in heart arteries.\n   * Coronary CT Angiography (CCTA) Scan: A CT scan that uses contrast dye to create detailed 3D pictures of heart arteries to look for plaque.\n2. A Treatment Trial (approximately 1,500 participants) - Based on the results of the CCTA, participants may be randomized into a two-year trial to test medications aimed at reducing or stabilizing plaque. Participants will have a 1 in 4 chance of receiving only placebo, and a 3 in 4 chance of receiving at least one active medication. Participants will take two pills once a day-either both active medications, one active and one placebo, or both placebos.\n\n   * Rosuvastatin 20 mg: a cholesterol-lowering medicine\n   * Colchicine 0.5 mg: a medication that lowers inflammation\n\nEveryone in the trial will be given information and advice on heart-healthy diet and lifestyle.\n\nParticipants will have up to two in-person visits for the screening study, then phone visits for the Treatment Trial at the beginning, 3 months, 12 months and 24 months when they will also have an in-person visit for a CCTA Scan. Participants will have blood drawn using an at-home collection device mailed to their home at the beginning, 3 months, and end of the study.",[63,64,65,29],"Coronary Artery Disease Risk Factors Multiple","Coronary Artery Disease Progression","Prevention & Control",[67,68,69,70,71,72],"Prevention","Heart Disease Prevention","Family History of Heart Disease","At risk for heart disease","coronary artery calcium","non-calcified coronary plaque","NOT_YET_RECRUITING","2026-02-25",{"date":76,"type":38},"2026-02-27",{"date":78,"type":21},"2026-07-01",{"date":80,"type":21},"2031-07",{"name":82,"class":83},"Duke University","OTHER"]