[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07293260":3,"trial-entities:NCT07293260":399,"trial-summary:NCT07293260":404},{"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":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":43,"secondary_outcomes":47,"sex":57,"minimum_age":58,"maximum_age":59,"healthy_volunteers":60,"eligibility_criteria":61,"std_ages":78,"locations":81,"central_contacts":384,"overall_officials":390,"references":394,"see_also_links":395},"NCT07293260","20230191","Olpasiran Trials of Cardiovascular Events and Lipoprotein(a) Reduction - Coronary Computed Tomography Angiography Trial","A Double-blind, Randomized, Placebo-controlled, Multi-center Study Evaluating the Safety, Tolerability, and Effect of Olpasiran on Coronary Artery Plaque Burden Assessed by Coronary Computed Tomography Angiography in Participants With Stable Atherosclerotic Cardiovascular Disease and Elevated Lipoprotein(a)","RECRUITING","2028-06-15","2026-04","2026-04-16","2026-03-23","Amgen","INDUSTRY",true,"The primary objective of this trial is to evaluate the effect of olpasiran, compared to placebo, on non-calcified plaque (NCP) volume as measured by Coronary Computed Tomography Angiography (CCTA).",null,[19],"Cardiovascular Disease",[21,22,23,24],"Stable Atherosclerotic Cardiovascular Disease","Elevated Lipoprotein(a)","Coronary Artery Plaque Burden","Olpasiran","INTERVENTIONAL","TREATMENT",[28],"PHASE3",{"count":30,"type":31},406,"ESTIMATED",[33,39],{"type":34,"name":24,"description":35,"armGroupLabels":36,"otherNames":37},"DRUG","Olpasiran will be administered SC.",[24],[38],"AMG 890",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Placebo","Placebo will be administered SC.",[40],[44],{"measure":45,"timeFrame":46},"Change in NCP Volume from Baseline to Week 72","Baseline to Week 72",[48,50,52,54],{"measure":49,"timeFrame":46},"Change in Low Attenuation Plaque Volume from Baseline to Week 72",{"measure":51,"timeFrame":46},"Change in Total Plaque Volume from Baseline to Week 72",{"measure":53,"timeFrame":46},"Change in Calcified Plaque Volume from Baseline to Week 72",{"measure":55,"timeFrame":56},"Number of Participants with Treatment-emergent Adverse Events (TEAEs)","Up to Week 74","ALL","35 Years","80 Years",false,{"inclusion":62,"exclusion":67,"raw_text":77},[63,64,65,66],"Age 35 to ≤ 80 years.","Lp(a) ≥ 200 nmol\u002FL during screening.","Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA.","History of myocardial infarction (presumed type 1 event due to plaque rupture\u002Ferosion) and\u002For coronary revascularization by percutaneous coronary intervention.",[68,69,70,71,72,73,74,75,76],"History of coronary artery bypass graft (CABG).","Moderate to severe renal dysfunction.","Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \\> 2 x ULN during screening.","History of hemorrhagic stroke.","History of major bleeding disorder.","Planned cardiac surgery or arterial revascularization.","Severe heart failure.","Current, recent, or planned lipoprotein apheresis.","Previously received ribonucleic acid therapy specifically targeting Lp(a).","Inclusion Criteria:\n\n* Age 35 to ≤ 80 years.\n* Lp(a) ≥ 200 nmol\u002FL during screening.\n* Angiographic evidence of coronary artery disease in at least one major epicardial vessel on screening CCTA.\n* History of myocardial infarction (presumed type 1 event due to plaque rupture\u002Ferosion) and\u002For coronary revascularization by percutaneous coronary intervention.\n\nExclusion Criteria:\n\n* History of coronary artery bypass graft (CABG).\n* Moderate to severe renal dysfunction.\n* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \\> 3 x upper limit of normal (ULN), or total bilirubin (TBL) \\> 2 x ULN during screening.\n* History of hemorrhagic stroke.\n* History of major bleeding disorder.\n* Planned cardiac surgery or arterial revascularization.\n* Severe heart failure.\n* Current, recent, or planned lipoprotein apheresis.\n* Previously received ribonucleic acid therapy specifically targeting Lp(a).",[79,80],"ADULT","OLDER_ADULT",[82,91,99,107,115,123,131,140,147,155,164,173,181,189,193,201,209,217,225,233,240,248,255,262,269,277,284,291,298,306,313,320,327,333,340,345,353,362,370,377],{"facility":83,"status":8,"city":84,"state":85,"zip":86,"country":87,"geoPoint":88},"Bridgeport Hospital","Bridgeport","Connecticut","06610","United States",{"lat":89,"lon":90},41.17923,-73.18945,{"facility":92,"status":8,"city":93,"state":94,"zip":95,"country":87,"geoPoint":96},"Jacksonville Center for Clinical Research","Jacksonville","Florida","32216",{"lat":97,"lon":98},30.33218,-81.65565,{"facility":100,"status":8,"city":101,"state":102,"zip":103,"country":87,"geoPoint":104},"Midwest Heart and Vascular Specialists","Overland Park","Kansas","66211",{"lat":105,"lon":106},38.98223,-94.67079,{"facility":108,"status":8,"city":109,"state":110,"zip":111,"country":87,"geoPoint":112},"Flourish Bowie","Bowie","Maryland","20715",{"lat":113,"lon":114},38.94278,-76.73028,{"facility":116,"status":8,"city":117,"state":118,"zip":119,"country":87,"geoPoint":120},"Montefiore Medical Center - Bronx","Philadelphia","Pennsylvania","19141",{"lat":121,"lon":122},39.95238,-75.16362,{"facility":124,"status":8,"city":125,"state":126,"zip":127,"country":87,"geoPoint":128},"Vital Heart and Vein","Humble","Texas","77338",{"lat":129,"lon":130},29.99883,-95.26216,{"facility":132,"status":8,"city":133,"state":134,"zip":135,"country":136,"geoPoint":137},"Advara HeartCare Wesley","Auchenflower","Queensland","4066","Australia",{"lat":138,"lon":139},-27.47443,152.99213,{"facility":141,"status":8,"city":142,"state":134,"zip":143,"country":136,"geoPoint":144},"University of The Sunshine Coast Clinical Trials, Sippy Downs","Sippy Downs","4556",{"lat":145,"lon":146},-26.71793,153.05475,{"facility":148,"status":8,"city":149,"state":150,"zip":151,"country":136,"geoPoint":152},"Advara HeartCare Leabrook","Leabrook","South Australia","5068",{"lat":153,"lon":154},-34.92976,138.65862,{"facility":156,"status":8,"city":157,"state":158,"zip":159,"country":160,"geoPoint":161},"North York Diagnostic and Cardiac Centre","Vaughan","Ontario","L6A 4N9","Canada",{"lat":162,"lon":163},43.8361,-79.49827,{"facility":165,"status":8,"city":166,"state":167,"zip":168,"country":169,"geoPoint":170},"Peking University First Hospital","Beijing","Beijing Municipality","100034","China",{"lat":171,"lon":172},39.9075,116.39723,{"facility":174,"status":8,"city":175,"state":176,"zip":177,"country":169,"geoPoint":178},"The First Affiliated Hospital of Zhengzhou University","Zhengzhou","Henan","450052",{"lat":179,"lon":180},34.75778,113.64861,{"facility":182,"status":8,"city":183,"state":184,"zip":185,"country":169,"geoPoint":186},"The Second Xiangya Hospital of Central South University","Changsha","Hunan","410011",{"lat":187,"lon":188},28.19874,112.97087,{"facility":190,"status":8,"city":183,"state":184,"zip":191,"country":169,"geoPoint":192},"The Third Xiangya Hospital of Central South University","410013",{"lat":187,"lon":188},{"facility":194,"status":8,"city":195,"state":196,"zip":197,"country":169,"geoPoint":198},"The Second Affiliated Hospital of Nanjing Medical University","Nanjing","Jiangsu","210011",{"lat":199,"lon":200},32.06167,118.77778,{"facility":202,"status":8,"city":203,"state":204,"zip":205,"country":169,"geoPoint":206},"General Hospital of Ningxia Medical University","Yinchuan","Ningxia","750004",{"lat":207,"lon":208},38.46806,106.27306,{"facility":210,"status":8,"city":211,"state":212,"zip":213,"country":169,"geoPoint":214},"Shaanxi Provincial Peoples Hospital","Xi'an","Shaanxi","710068",{"lat":215,"lon":216},34.25833,108.92861,{"facility":218,"status":8,"city":219,"state":220,"zip":221,"country":169,"geoPoint":222},"Jinan Central Hospital","Jinan","Shandong","250013",{"lat":223,"lon":224},36.66833,116.99722,{"facility":226,"status":8,"city":227,"zip":228,"country":229,"geoPoint":230},"Regionshospitalet Gødstrup","Herning","7400","Denmark",{"lat":231,"lon":232},56.13615,8.97662,{"facility":234,"status":8,"city":235,"zip":236,"country":229,"geoPoint":237},"Regionshospitalet Viborg","Viborg","8800",{"lat":238,"lon":239},56.45319,9.40201,{"facility":241,"status":8,"city":242,"zip":243,"country":244,"geoPoint":245},"Centre Hospitalier Universitaire de Nice - Hopital Pasteur","Nice","06000","France",{"lat":246,"lon":247},43.70313,7.26608,{"facility":249,"status":8,"city":250,"zip":251,"country":244,"geoPoint":252},"Centre Hospitalier Universitaire de Bordeaux Hopital Haut-Leveque","Pessac","33604",{"lat":253,"lon":254},44.80565,-0.6324,{"facility":256,"status":8,"city":257,"zip":258,"country":244,"geoPoint":259},"Centre Hospitalier Universitaire de Toulouse - Hopital Rangueil","Toulouse","31059",{"lat":260,"lon":261},43.60426,1.44367,{"facility":263,"status":8,"city":264,"zip":265,"country":244,"geoPoint":266},"Centre Hospitalier Regional Universitaire de Tours - Hopital Trousseau","Tours","37044",{"lat":267,"lon":268},47.39484,0.70398,{"facility":270,"status":8,"city":271,"zip":272,"country":273,"geoPoint":274},"Charite - Universitaetsmedizin Berlin, Campus Benjamin Franklin","Berlin","12203","Germany",{"lat":275,"lon":276},52.52437,13.41053,{"facility":278,"status":8,"city":279,"zip":280,"country":273,"geoPoint":281},"Universitaetsklinikum Essen","Essen","45147",{"lat":282,"lon":283},51.45657,7.01228,{"facility":285,"status":8,"city":286,"zip":287,"country":273,"geoPoint":288},"Universitaetsklinikum Frankfurt","Frankfurt am Main","60590",{"lat":289,"lon":290},50.11552,8.68417,{"facility":292,"status":8,"city":293,"zip":294,"country":273,"geoPoint":295},"Klinikum rechts der Isar der TUM","München","80636",{"lat":296,"lon":297},51.60698,13.31243,{"facility":299,"status":8,"city":300,"zip":301,"country":302,"geoPoint":303},"Azienda Ospedaliera Universitaria di Ferrara Arcispedale Sant Anna","Ferrara","44124","Italy",{"lat":304,"lon":305},44.83804,11.62057,{"facility":307,"status":8,"city":308,"zip":309,"country":302,"geoPoint":310},"IRCCS Centro Cardiologico Monzino","Milan","20138",{"lat":311,"lon":312},42.78235,12.59836,{"facility":314,"status":8,"city":315,"zip":316,"country":302,"geoPoint":317},"IRCCS Policlinico San Donato","San Donato Milanese","20097",{"lat":318,"lon":319},45.41047,9.26838,{"facility":321,"status":8,"city":322,"zip":323,"country":302,"geoPoint":324},"Azienda Ospedaliera Ordine Mauriziano di Torino","Torino","10128",{"lat":325,"lon":326},44.88856,11.99138,{"facility":328,"status":8,"city":329,"state":330,"zip":331,"country":332},"Tomakomai City Hospital","Tomakomai-shi","Hokkaido","053-8567","Japan",{"facility":334,"status":8,"city":335,"state":335,"zip":336,"country":332,"geoPoint":337},"Osaka Keisatsu Hospital","Osaka","543-0042",{"lat":338,"lon":339},34.69379,135.50107,{"facility":341,"status":8,"city":342,"state":343,"zip":344,"country":332},"University of Yamanashi Hospital","Chuo-shi","Yamanashi","409-3898",{"facility":346,"status":8,"city":347,"zip":348,"country":349,"geoPoint":350},"Tergooiziekenhuizen, locatie Hilversum","Hilversum","1201 DA","Netherlands",{"lat":351,"lon":352},52.22333,5.17639,{"facility":354,"status":8,"city":355,"state":356,"zip":357,"country":358,"geoPoint":359},"Hospital Universitario Virgen Macarena","Seville","Andalusia","41009","Spain",{"lat":360,"lon":361},37.38283,-5.97317,{"facility":363,"status":8,"city":364,"state":365,"zip":366,"country":358,"geoPoint":367},"Hospital Alvaro Cunqueiro","Vigo","Galicia","36312",{"lat":368,"lon":369},42.23282,-8.72264,{"facility":371,"status":8,"city":372,"state":372,"zip":373,"country":358,"geoPoint":374},"Hospital Universitari i Politecnic La Fe","Valencia","46026",{"lat":375,"lon":376},39.47391,-0.37966,{"facility":378,"status":8,"city":379,"zip":380,"country":358,"geoPoint":381},"Hospital Universitario Ramon y Cajal","Madrid","28023",{"lat":382,"lon":383},40.4165,-3.70256,[385],{"name":386,"role":387,"phone":388,"email":389},"Amgen Call Center","CONTACT","866-572-6436","medinfo@amgen.com",[391],{"name":392,"affiliation":13,"role":393},"MD","STUDY_DIRECTOR",[],[396],{"label":397,"url":398},"AmgenTrials clinical trials website","http:\u002F\u002Fwww.amgentrials.com",{"nct_id":4,"conditions":400,"biomarkers":403},[401,402],"Atherosclerosis","Cardiovascular Disorder",[],{"nct_id":4,"found":15,"summary":405,"prompt_version":415},{"design":406,"status":407,"heading":408,"summary":409,"follow_up":410,"word_count":411,"commitments":412,"compensation":413,"drugs_mentioned":414},"This is an interventional study with a planned enrollment of 406 participants. It compares olpasiran to a placebo.","completed","Olpasiran for Cardiovascular Disease and Lipoprotein(a) Reduction","This study is testing a drug called olpasiran to see if it can reduce the amount of non-calcified plaque (NCP) in your arteries, compared to a placebo (an inactive substance). NCP is a type of buildup in blood vessels linked to heart disease. You may be able to join if you are 35 to 80 years old, have high levels of Lp(a) (a type of fat in the blood), and have existing coronary artery disease or a history of heart attack or a procedure to open blocked arteries. The main goal is to measure changes in NCP volume over 72 weeks using a special heart scan called Coronary Computed Tomography Angiography (CCTA). The current recruitment status is unclear.","The primary endpoint is measured from baseline to Week 72.",118,"Not specified in the trial record.","Not stated in the trial record.",[24,40],"v2"]