[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07232069":3,"trial-entities:NCT07232069":451,"trial-summary:NCT07232069":455},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":23,"study_type":30,"primary_purpose":31,"phases":32,"enrollment_info":34,"interventions":37,"primary_outcomes":59,"secondary_outcomes":64,"sex":101,"minimum_age":102,"maximum_age":103,"healthy_volunteers":104,"eligibility_criteria":105,"std_ages":109,"locations":111,"central_contacts":443,"overall_officials":448,"references":449,"see_also_links":450},"NCT07232069","Pro00118744","PRE-EMPT: Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis","Prospective RandomizEd Evaluation and Management of Premature aTherosclerosis","RECRUITING","2031-07","2026-07","2026-08-03","2026-07-21","Duke University","OTHER",true,"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.","The PRE-EMPT trial will be a 2x2 factorial, double-masked, placebo-controlled randomized trial of the effects of high-intensity statin and low-dose colchicine, alone and in combination, on CCTA-defined Non-Calcified Coronary Plaque (NCCP) volume at 2 years. Participants found through the screening study with CAC 1-99, or through the known plaque pathway, will be eligible for the trial if they have NCCP without severe stenosis or any other exclusion criteria. Study drug will be delivered directly to participants' homes, lab samples will be self-collected at home, and all study visits will be virtual except the imaging visits (up to 3 over 2 years). The only in-person study activities will be the CAC scan, if applicable, and CCTA at baseline and 2 years. The investigators anticipate that this approach will be attractive to middle-aged, busy individuals who are otherwise healthy and asymptomatic. Importantly, all participants in PRE-EMPT will receive an mHealth lifestyle intervention designed to support behavioral modification, ensuring that all individuals benefit from evidence-based strategies for cardiovascular risk reduction.",[19,20,21,22],"Coronary Artery Disease Risk Factors Multiple","Coronary Artery Disease Progression","Prevention & Control","Premature Atherosclerosis",[24,25,26,27,28,29],"Prevention","Heart Disease Prevention","Family History of Heart Disease","At risk for heart disease","coronary artery calcium","non-calcified coronary plaque","INTERVENTIONAL","PREVENTION",[33],"PHASE3",{"count":35,"type":36},1500,"ESTIMATED",[38,47,54],{"type":39,"name":40,"description":41,"armGroupLabels":42,"otherNames":45},"DRUG","Rosuvastatin 20 Mg Oral Tablet","Statin",[43,44],"rosuvastatin 20mg plus colchicine 0.5mg","rosuvastatin 20mg plus colchicine-matched placebo",[46],"Crestor",{"type":39,"name":48,"description":49,"armGroupLabels":50,"otherNames":52},"Colchicine 0.5 MG Oral Tablet Once Daily","Anti-inflammatory",[51,43],"colchicine 0.5mg plus rosuvastatin-matched placebo",[53],"Lodoco",{"type":39,"name":55,"description":56,"armGroupLabels":57},"Placebo","Placebo, non-active, drug-matched",[51,58,44],"placebo plus placebo",[60],{"measure":61,"description":62,"timeFrame":63},"Non-calcified plaque volume (NCPV) on CCTA at 2 years, adjusted for baseline NCPV.","Plaque volume in mm3 in each group","2 years",[65,69,72,75,78,81,84,87,90,93,96,99],{"measure":66,"description":67,"timeFrame":68},"Number of participants with Drug Discontinuation","Drug Tolerability outcome","Up to 2 years",{"measure":70,"description":71,"timeFrame":68},"Overall drug treatment adherence","Number of days on study drugs",{"measure":73,"description":74,"timeFrame":68},"Safety events of special interest","Number of safety events of special interest per group",{"measure":76,"description":77,"timeFrame":68},"Total plaque volume","Plaque volume in mm3 per group",{"measure":79,"description":80,"timeFrame":68},"Low-attenuation plaque volume","Low attenuated plaque volume in mm3 per group",{"measure":82,"description":83,"timeFrame":68},"Calcified plaque volume","Calcified plaque volume in mm3 per group",{"measure":85,"description":86,"timeFrame":68},"Number of participants with stenosis","Number of participants with stenosis per group",{"measure":88,"description":89,"timeFrame":68},"Segment involvement score","Average score per group",{"measure":91,"description":92,"timeFrame":68},"Number of participants with qualitative calcified, partially calcified and non-calcified plaque composition","Number of participants with each plaque composition description per group",{"measure":94,"description":95,"timeFrame":68},"Number of participants with High-risk plaque features (positive remodeling, spotty calcium, napkin ring sign)","Number of participants with each plaque feature (high-risk) per group",{"measure":97,"timeFrame":98},"Change in LDL-C (low-density lipoprotein cholesterol)","Baseline to 2 years",{"measure":100,"timeFrame":98},"Change in non-HDL-C (high-density lipoprotein cholesterol)","ALL","30 Years","60 Years",false,{"inclusion":106,"exclusion":107,"raw_text":108},[],[],"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.",[110],"ADULT",[112,130,145,160,171,185,199,214,229,244,258,270,281,296,310,325,340,354,369,384,399,414,428],{"facility":113,"status":8,"city":114,"state":115,"zip":116,"country":117,"contacts":118,"geoPoint":127},"University of Alabama at Birmingham","Birmingham","Alabama","35205","United States",[119,124],{"name":120,"role":121,"phone":122,"email":123},"Dalton Norwood","CONTACT","909-786-8315","daltonnorwood@uabmc.edu",{"name":125,"role":126},"Kevin Riggs, MD","PRINCIPAL_INVESTIGATOR",{"lat":128,"lon":129},33.52066,-86.80249,{"facility":131,"status":132,"city":133,"state":115,"zip":134,"country":117,"contacts":135,"geoPoint":142},"Cardiology Associates","NOT_YET_RECRUITING","Mobile","36608",[136,140],{"name":137,"role":121,"phone":138,"email":139},"Lynn Ward, RN BSN CCRC","251-607-9797","lynnward@cardassoc.com",{"name":141,"role":126},"Jason Cole, MD",{"lat":143,"lon":144},30.69436,-88.04305,{"facility":146,"status":132,"city":147,"state":148,"zip":149,"country":117,"contacts":150,"geoPoint":157},"University of California, Los Angeles","Los Angeles","California","90095",[151,155],{"name":152,"role":121,"phone":153,"email":154},"Lynae Edmunds","310--210-9806","laedmunds@mednet.ucla.edu",{"name":156,"role":126},"Karol Watson, MD",{"lat":158,"lon":159},34.05223,-118.24368,{"facility":161,"status":8,"city":147,"state":148,"zip":162,"country":117,"contacts":163,"geoPoint":170},"Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center","90502",[164,168],{"name":165,"role":121,"phone":166,"email":167},"Sajad Hamal","310-974-9336","shamal@lundquist.org",{"name":169,"role":126},"Matthew Budoff, MD",{"lat":158,"lon":159},{"facility":172,"status":132,"city":173,"state":174,"zip":175,"country":117,"contacts":176,"geoPoint":182},"Wellstar Kennestone Hospital","Hiram","Georgia","30141",[177,181],{"name":178,"role":121,"phone":179,"email":180},"Frank Corrigan, MD","678-324-4444","frank.corrigan@wellstar.org",{"name":178,"role":126},{"lat":183,"lon":184},33.87566,-84.76216,{"facility":186,"status":132,"city":187,"state":188,"zip":189,"country":117,"contacts":190,"geoPoint":196},"University of Chicago","Chicago","Illinois","60637",[191,195],{"name":192,"role":121,"phone":193,"email":194},"Tamar Polonsky, MD","773-702-1409","tpolonsky@bsd.uchicago.edu",{"name":192,"role":126},{"lat":197,"lon":198},41.85003,-87.65005,{"facility":200,"status":132,"city":201,"state":202,"zip":203,"country":117,"contacts":204,"geoPoint":211},"Johns Hopkins University","Baltimore","Maryland","21287",[205,209],{"name":206,"role":121,"phone":207,"email":208},"Prati Pratishruti, MBBS","410-301-1245","fpratis1@jhu.edu",{"name":210,"role":126},"Michael Blaha, MD",{"lat":212,"lon":213},39.29038,-76.61219,{"facility":215,"status":132,"city":216,"state":217,"zip":218,"country":117,"contacts":219,"geoPoint":226},"Massachusetts General Hospital Brigham","Boston","Massachusetts","02114",[220,224],{"name":221,"role":121,"phone":222,"email":223},"Pearl Lee, MSc","617-721-7783","plee23@mgh.harvard.edu",{"name":225,"role":126},"Michael Honigberg, MD",{"lat":227,"lon":228},42.35843,-71.05977,{"facility":230,"status":132,"city":231,"state":232,"zip":233,"country":117,"contacts":234,"geoPoint":241},"Essentia Health","Duluth","Minnesota","55805",[235,239],{"name":236,"role":121,"phone":237,"email":238},"Martha Vanderlinde, BS","218-786-2729","Martha.Vanderlinde@essentiahealth.org",{"name":240,"role":126},"Catherine Benzinger, MD",{"lat":242,"lon":243},46.78327,-92.10658,{"facility":245,"status":132,"city":246,"state":247,"zip":248,"country":117,"contacts":249,"geoPoint":255},"Northern Westchester Hospital","Mount Kisco","New York","10549",[250,254],{"name":251,"role":121,"phone":252,"email":253},"Dina Katz, MD","914-762-5810","PRE-EMPT@northwell.edu",{"name":251,"role":126},{"lat":256,"lon":257},41.20426,-73.72708,{"facility":259,"status":132,"city":247,"state":247,"zip":260,"country":117,"contacts":261,"geoPoint":267},"New York University Langone","10016",[262,266],{"name":263,"role":121,"phone":264,"email":265},"Harmony Reynolds, MD","212-263-4320","PREEMPT@nyulangone.org",{"name":263,"role":126},{"lat":268,"lon":269},40.71427,-74.00597,{"facility":271,"status":8,"city":247,"state":247,"zip":272,"country":117,"contacts":273,"geoPoint":280},"Weill Cornell Medicine","10021",[274,278],{"name":275,"role":121,"phone":276,"email":277},"Dolores Reynolds, RN","212-746-4617","dtr2001@med.cornell.edu",{"name":279,"role":126},"Sam Kim, MD",{"lat":268,"lon":269},{"facility":282,"status":8,"city":283,"state":284,"zip":285,"country":117,"contacts":286,"geoPoint":293},"Duke University Hospital","Durham","North Carolina","27710",[287,291],{"name":288,"role":121,"phone":289,"email":290},"Niki Huffman","919-681-6458","niki.huffman@duke.edu",{"name":292,"role":126},"Nishant Shah, MD",{"lat":294,"lon":295},35.99403,-78.89862,{"facility":297,"status":132,"city":298,"state":284,"zip":299,"country":117,"contacts":300,"geoPoint":307},"Wake Forest University, Advocate Health","Winston-Salem","27157",[301,305],{"name":302,"role":121,"phone":303,"email":304},"Sophia Dawson, BA","336-713-2338","Sophia.Dawson@advocatehealth.org",{"name":306,"role":126},"Michael Shapiro, MD",{"lat":308,"lon":309},36.09986,-80.24422,{"facility":311,"status":132,"city":312,"state":313,"zip":314,"country":117,"contacts":315,"geoPoint":322},"Oregon Health and Sciences University","Portland","Oregon","97239",[316,320],{"name":317,"role":121,"phone":318,"email":319},"John Halvorson","503-418-1679","halvorsj@ohsu.edu",{"name":321,"role":126},"Maros Ferencik, MD",{"lat":323,"lon":324},45.52345,-122.67621,{"facility":326,"status":132,"city":327,"state":328,"zip":329,"country":117,"contacts":330,"geoPoint":337},"Thomas Jefferson University","Philadelphia","Pennsylvania","19107",[331,335],{"name":332,"role":121,"phone":333,"email":334},"Caroline Freeman, BS","215-792-3872","Caroline.Freeman@Jefferson.edu",{"name":336,"role":126},"Chris Chambers, MD",{"lat":338,"lon":339},39.95238,-75.16362,{"facility":341,"status":132,"city":342,"state":328,"zip":343,"country":117,"contacts":344,"geoPoint":351},"University of Pittsburgh Medical Center","Pittsburgh","15213",[345,349],{"name":346,"role":121,"phone":347,"email":348},"Karli Drewencki","412-647-2931","drewenckikr2@upmc.edu",{"name":350,"role":126},"Anum Saeed, MD",{"lat":352,"lon":353},40.44062,-79.99589,{"facility":355,"status":132,"city":356,"state":357,"zip":358,"country":117,"contacts":359,"geoPoint":366},"Medical University of South Carolina (MUSC)","Charleston","South Carolina","29425",[360,364],{"name":361,"role":121,"phone":362,"email":363},"Melissa Amitrano, MPH","843-876-5009","amitrano@musc.edu",{"name":365,"role":126},"Sheldon Litwin, MD",{"lat":367,"lon":368},32.77632,-79.93275,{"facility":370,"status":132,"city":371,"state":372,"zip":373,"country":117,"contacts":374,"geoPoint":381},"Vanderbilt University","Nashville","Tennessee","37203",[375,379],{"name":376,"role":121,"phone":377,"email":378},"Gabriella Davies Thoppil, MD MPH","615-421-1143","g.thoppil@vumc.org",{"name":380,"role":126},"Deepak Gupta, MD",{"lat":382,"lon":383},36.16589,-86.78444,{"facility":385,"status":132,"city":386,"state":387,"zip":388,"country":117,"contacts":389,"geoPoint":396},"Houston Methodist Hospital","Houston","Texas","77030",[390,394],{"name":391,"role":121,"phone":392,"email":393},"Peyton Martin","443-413-6350","knasir@houstonmethodist.org",{"name":395,"role":126},"Khurrrram Nasir, MD",{"lat":397,"lon":398},29.76328,-95.36327,{"facility":400,"status":132,"city":401,"state":402,"zip":403,"country":117,"contacts":404,"geoPoint":411},"University of Virginia (UVA)","Charlottesville","Virginia","22903",[405,409],{"name":406,"role":121,"phone":407,"email":408},"James Ingersoll","434-982-1058","WFC5KC@uvahealth.org",{"name":410,"role":126},"Todd Villines, MD",{"lat":412,"lon":413},38.02931,-78.47668,{"facility":415,"status":132,"city":416,"state":402,"zip":417,"country":117,"contacts":418,"geoPoint":425},"Inova Health System","Fairfax","22031",[419,423],{"name":420,"role":121,"phone":421,"email":422},"Mahira Awan","571-472-8570","mahira.awan@inova.org",{"name":424,"role":126},"Jared Spitz, MD",{"lat":426,"lon":427},38.84622,-77.30637,{"facility":429,"status":132,"city":430,"state":431,"zip":432,"country":117,"contacts":433,"geoPoint":440},"Marshfield Clinical Research Institute","Marshfield","Wisconsin","54449",[434,438],{"name":435,"role":121,"phone":436,"email":437},"Kelly Scheffen","715-221-7285","preempt@marshfieldresearch.org",{"name":439,"role":126},"Jeff VanWormer",{"lat":441,"lon":442},44.66885,-90.1718,[444],{"name":445,"role":121,"phone":446,"email":447},"Rachel Olson, Project Manager","919-309-5544","rachel.e.olson@duke.edu",[],[],[],{"nct_id":4,"conditions":452,"biomarkers":454},[453],"Premature atherosclerosis",[],{"nct_id":4,"found":15,"summary":456,"prompt_version":466},{"design":457,"status":458,"heading":459,"summary":460,"follow_up":461,"word_count":462,"commitments":463,"compensation":464,"drugs_mentioned":465},"This is a randomized, double-blind, placebo-controlled study involving about 1500 participants. It will compare the effects of Rosuvastatin, Colchicine, or both, against a placebo.","completed","PRE-EMPT: Preventing Early Heart Disease Progression","This study, PRE-EMPT, is looking for people aged 30-60 to help understand and prevent the progression of early heart disease. It aims to see if early treatment can help reduce the amount of \"plaque\" (cholesterol buildup) in heart arteries. You might be eligible if you have certain heart disease risk factors and early plaque detected by a Coronary Artery Calcium (CAC) scan. The study will test two medications, Rosuvastatin 20 Mg (a statin) and Colchicine 0.5 MG (an anti-inflammatory), alone or in combination, against a placebo (an inactive substance). Success will be measured by changes in non-calcified plaque volume in your heart arteries after two years. The current status of this study is unclear.","Your plaque volume will be measured at 2 years to assess the study's primary outcome.",114,"You will have virtual study visits, self-collect lab samples at home, and have up to three in-person imaging visits over two years, including CCTA scans at the beginning and end of the study.","Not stated in the trial record.",[55],"v2"]