Arteriosclerosis Clinical Trial
Official title:
Phase 3 Randomized, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of MK-0616 in Reducing Major Adverse Cardiovascular Events in Participants at High Cardiovascular Risk
This is a phase 3, randomized, placebo-controlled study of the efficacy and safety of MK-0616, an oral proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor, in participants with high cardiovascular risk. The primary objective is to evaluate the efficacy of MK-0616 compared with placebo in increasing the time to the first occurrence of major adverse cardiovascular events (MACE) including coronary heart disease (CHD) death, ischemic stroke, myocardial infarction (MI), acute limb ischemia or major amputation, or urgent arterial revascularization.
| Status | Recruiting |
| Enrollment | 14550 |
| Est. completion date | November 29, 2029 |
| Est. primary completion date | November 29, 2029 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: - Meets one of the following: 1. Age =18 years with a history of a major atherosclerotic cardiovascular disease (ASCVD) event defined as at least 1 of the following: =30 days post MI (presumed Type 1 due to plaque rupture or erosion); =30 days post ischemic stroke (presumed due to atherosclerosis); or =30 days post successful peripheral (carotid or lower extremity) arterial revascularization (surgical or endovascular) or major (ankle or above) amputation due to atherosclerosis; or 2. High risk for first major ASCVD event defined as at least 1 of the following: Age =50 years with evidence of coronary artery disease; Age =50 years with evidence of atherosclerotic cerebrovascular disease; Age =50 years with evidence of peripheral arterial disease; or Age =60 years with diabetes mellitus and at least one of the following: microvascular disease or urine albumin-creatinine ratio =30 mg/mmol within 6 months before Visit 1, daily insulin use, or diabetes for =10 years - Has fasted lipid values (evaluated by the Central Laboratory) at Visit 1 (Screening) as follows: 1. History of major ASCVD Event: LDL-C =70 mg/dL (1.81 mmol/L) OR non-HDL-C =100 mg/dL (2.59 mmol/L) 2. High risk for first major ASCVD Event: LDL-C =90 mg/dL (2.33 mmol/L) OR non-HDL-C =120 mg/dL (3.11 mmol/L) - Is treated with moderate- or high-intensity statin (± nonstatin lipid-lowering therapy [LLT]) at Visit 1 - Is on a stable dose of all background LLTs (including statin and nonstatin agents) for at least 30 days before Visit 1 (Screening) with no medication or dose changes planned during the participation in the study Exclusion Criteria: - Has a history of homozygous familial hypercholesterolemia (FH) based on genetic or clinical criteria, compound heterozygous FH, or double heterozygous FH - Has New York Heart Association Class IV heart failure, last known Left Ventricular Ejection Fraction =25% by any imaging method, or had a Heart Failure hospitalization within 3 months before Visit 1 (Screening) - Has recurrent ventricular tachycardia within 3 months prior to randomization - Has a planned arterial revascularization procedure - Is undergoing or previously underwent an LDL-C apheresis program within 3 months before Visit 1 (Screening) or plans to initiate an LDL-C apheresis program - Was previously treated/is being treated with certain other cholesterol lowering medications, including protein convertase subtilisin/kexin type 9 (PCSK9) inhibitors without adequate washout. - Has a fasting triglyceride value =400 mg/dL (=4.52 mmol/L) at Visit 1 (Screening) - Has history of severe renal insufficiency defined as estimated glomerular filtration rate <30 mL/min/1.73 m2 at Visit 1 (Screening) or has end-stage renal disease on dialysis. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | CEMEDIC ( Site 0609) | Buenos Aires | |
| Argentina | CIPREC-CIPREC Sede Arenales ( Site 0624) | Buenos Aires | Caba |
| Argentina | Fundación favaloro para la Docencia e Investigación Médica ( Site 0606) | Buenos Aires | Caba |
| Argentina | Fundación Respirar ( Site 0610) | Buenos Aires | |
| Argentina | CEDIC ( Site 0612) | Caba | Buenos Aires |
| Argentina | Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada ( Site 0604) | Ciudad Autonoma de Buenos Aires | Caba |
| Argentina | Centro de Investigaciones Metabólicas (CINME)-Cardiology ( Site 0620) | Ciudad Autónoma de Buenos Aires | Buenos Aires |
| Argentina | Instituto Médico DAMIC ( Site 0603) | Córdoba | Cordoba |
| Argentina | Framingham Centro Médico ( Site 0625) | La Plata | Buenos Aires |
| Argentina | CIMeL ( Site 0613) | Lanus | Buenos Aires |
| Argentina | Instituto de Investigaciones Clínicas Mar del Plata ( Site 0605) | Mar del Plata | Buenos Aires |
| Argentina | DIM Clínica Privada ( Site 0627) | Ramos Mejía | Buenos Aires |
| Argentina | Fundacion Estudios Clinicos ( Site 0619) | Rosario | Santa Fe |
| Argentina | Instituto de Investigaciones Clinicas Rosario ( Site 0602) | Rosario | Santa Fe |
| Argentina | Laboratorio de Hemostasia y Trombosis ( Site 0623) | Rosario | Santa Fe |
| Argentina | Go Centro Medico San Nicolás ( Site 0621) | San Nicolas | Buenos Aires |
| Argentina | Centro de Investigaciones Clinicas del Litoral ( Site 0607) | Santa Fe | |
| Argentina | Clínica de Nefrología, Urología y Enfermedades Cardiovasculares ( Site 0615) | Santa Fe | |
| Argentina | Instituto de Investigaciones Clinicas Zarate ( Site 0600) | Zárate | Buenos Aires |
| Australia | Paratus Clinical Research Western Sydney ( Site 2805) | Blacktown | New South Wales |
| Australia | Paratus Clinical Research Canberra ( Site 2804) | Bruce | Australian Capital Territory |
| Australia | Royal Prince Alfred Hospital ( Site 2808) | Camperdown | New South Wales |
| Australia | Victorian Heart Hospital-Monash Cardiovascular Research Centre (MCRC) ( Site 2803) | Clayton | Victoria |
| Australia | Paratus Clinical Research Central Coast ( Site 2806) | Kanwal | New South Wales |
| Brazil | Centro de Pesquisa Clinica do Coracao ( Site 0713) | Aracaju | Sergipe |
| Brazil | Hospital Universitário São Francisco de Assis - Bragança Paulista ( Site 0725) | Bragança Paulista | Sao Paulo |
| Brazil | Centro de Pesquisa Clinica do Brasil ( Site 0719) | Brasilia | Distrito Federal |
| Brazil | Hospital Angelina Caron ( Site 0702) | Campina Grande do Sul | Parana |
| Brazil | Instituto de Pesquisa clinica de Campinas ( Site 0706) | Campinas | Sao Paulo |
| Brazil | Hospital do Rocio ( Site 0721) | Campo Largo | Parana |
| Brazil | Hospital Universitário ( Site 0723) | Canoas | Rio Grande Do Sul |
| Brazil | Centro de Pesquisas em Diabetes e Doenças Endócrino-Metabólicas ( Site 0728) | Fortaleza | Ceara |
| Brazil | Universidade Federal de Goias ( Site 0717) | Goiania | Goias |
| Brazil | Hospital Mae de Deus ( Site 0716) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Hospital Nossa Senhora da Conceição-FZ PESQUISA E SERVIÇOS EM CARDIOLOGIA CLÍNICA LTDA ( Site 0712) | Porto Alegre | Rio Grande Do Sul |
| Brazil | Instituto de Cardiologia do Rio Grande do Sul ( Site 0704) | Porto Alegre | Rio Grande Do Sul |
| Brazil | IBPClin - Instituto Brasil de Pesquisa Clínica ( Site 0715) | Rio de Janeiro | |
| Brazil | Fundação Faculdade Regional de Medicina de São José do Rio Preto ( Site 0707) | São José do Rio Preto | Sao Paulo |
| Brazil | CEPIC - Centro Paulista de Investigação Clínica ( Site 0710) | São Paulo | Sao Paulo |
| Brazil | Instituto Dante Pazzanese de Cardiology-Fundação Adib Jatene ( Site 0708) | São Paulo | Sao Paulo |
| Brazil | Integral Pesquisa e Ensino ( Site 0709) | Votuporanga | Sao Paulo |
| Canada | Cambridge Cardiac Care Centre ( Site 0508) | Cambridge | Ontario |
| Canada | Ecogene-21 ( Site 0510) | Chicoutimi | Quebec |
| Canada | OCT Research ULC ( Site 0512) | Kelowna | British Columbia |
| Canada | Institut de Cardiologie de Montreal ( Site 0506) | Montreal | Quebec |
| Canada | North York Diagnostic and Cardiac Centre ( Site 0514) | North York | Ontario |
| Canada | Oakville Cardiovascular Research LP ( Site 0507) | Oakville | Ontario |
| Canada | Centre intégré de santé et de services sociaux de Lanaudière - Hopital Pierre-Le Gardeur. ( Site 050 | Terrebonne | Quebec |
| Canada | Corcare ( Site 0511) | Toronto | Ontario |
| Canada | Diex Recherche Trois-Rivieres ( Site 0505) | Trois-Rivieres | Quebec |
| Chile | Espacio Eme ( Site 0806) | Ñuñoa | Region M. De Santiago |
| Chile | Servicios Medicos Godoy ( Site 0810) | Providencia | Region M. De Santiago |
| Chile | CECIM ( Site 0811) | Santiago | Region M. De Santiago |
| Chile | Centro de Investigacion Clinicadela Universidad Catolica ( Site 0812) | Santiago | Region M. De Santiago |
| Chile | Clínica Ensenada ( Site 0801) | Santiago | Region M. De Santiago |
| Chile | Enroll SpA ( Site 0803) | Santiago | Region M. De Santiago |
| Chile | FALP-UIDO ( Site 0815) | Santiago | Region M. De Santiago |
| Chile | Universidad de Chile - Hospital Clínico Universidad de Chile ( Site 0800) | Santiago | Region M. De Santiago |
| Chile | Centro de Investigación del Maule ( Site 0816) | Talca | Maule |
| Chile | Centro De Estudios Cardiologicos Y De Medicina Interna ( Site 0805) | Temuco | Araucania |
| Chile | Clinical Research Chile SpA ( Site 0804) | Valdivia | Los Rios |
| Chile | ONCOCENTRO APYS ( Site 0808) | Viña del Mar | Valparaiso |
| China | Baotou Central Hospital-Cardiology ( Site 3436) | Bao Tou | Inner Mongolia |
| China | Beijing Anzhen Hospital, Capital Medical University-Cardiovascular ( Site 3400) | Beijing | Beijing |
| China | Beijing Tsinghua Changgung Hospital ( Site 3423) | Beijing | Beijing |
| China | Jilin Province People's Hospital-Department of Cardiology ( Site 3442) | Changchun | Jilin |
| China | Changsha Central Hospital-Cardiovascular ( Site 3404) | Changsha | Hunan |
| China | The Third Hospital of Changsha-Cardiovascular department ( Site 3434) | Changsha | Hunan |
| China | The Third Xiangya Hospital of Central South University-Cardiology ( Site 3412) | Changsha | Hunan |
| China | Changzhou Second People's Hospital-Cardiology ( Site 3459) | Changzhou | Jiangsu |
| China | Chengdu Second Municipal People's Hospital ( Site 3419) | Chengdu | Sichuan |
| China | The Third People's Hospital of Chengdu (CDTPH) ( Site 3430) | Chengdu | Sichuan |
| China | Chifeng Hospital-Department of Cardiology ( Site 3433) | Chifeng | Inner Mongolia |
| China | 2nd Affiliated Hospital Chongqing Medical Universi ( Site 3424) | Chongqing | Chongqing |
| China | Daqing People's Hospital-Cardiology ( Site 3470) | Daqing | Heilongjiang |
| China | Shunde Hospital of Southern Medical Univesity ( Site 3427) | Foshan | Guangdong |
| China | Guangdong Provincial People's Hospital-Cardiology ( Site 3402) | Guangzhou | Guangdong |
| China | Zhujiang Hospital ( Site 3415) | Guangzhou | Guangdong |
| China | The Affiliated Hospital of Guizhou Medical University ( Site 3486) | Guiyang | Guizhou |
| China | Hainan General Hospital ( Site 3409) | Haikou | Hainan |
| China | Second Affiliated hospital of Anhui Medical University-Cardiology ( Site 3458) | Hefei | Anhui |
| China | Inner Mongolia People's Hospital ( Site 3439) | Hohhot | Inner Mongolia |
| China | Huizhou Municipal Central Hospital ( Site 3467) | Huizhou | Guangdong |
| China | Jiangmen Center Hospital ( Site 3492) | Jiangmen | Guangdong |
| China | Taizhou Hospital of Zhejiang Province-Cardiovascular Department ( Site 3472) | Linhai | Zhejiang |
| China | Linyi People's Hospital ( Site 3468) | Linyi | Shandong |
| China | Lishui Central Hospital ( Site 3455) | Lishui City | Zhejiang |
| China | The Third Hospital of Nanchang ( Site 3454) | Nanchang | Jiangxi |
| China | The Second Affiliated Hospital of Nanjing Medical University-Cardiology ( Site 3480) | Nanjing | Jiangsu |
| China | Nanyang First People's Hospital ( Site 3469) | Nanyang | Henan |
| China | The Second People's Hospital of Neijiang ( Site 3482) | Neijiang | Sichuan |
| China | Pingxiang People's Hospital-Cardiology ( Site 3473) | Pingxiang | Jiangxi |
| China | The Third Affiliated Hospital of Qiqihar Medical University ( Site 3465) | Qiqihar | Heilongjiang |
| China | Shanghai East Hospital ( Site 3485) | Shanghai | Shanghai |
| China | Shanghai General Hospital ( Site 3479) | Shanghai | Shanghai |
| China | Shanghai Tongji Hospital ( Site 3431) | Shanghai | Shanghai |
| China | The People's Hospital of Liaoning Province-Cardiology ( Site 3453) | Shenyang | Liaoning |
| China | The University of Hong Kong-Shenzhen Hospital-Cardiovascular department ( Site 3414) | Shenzhen | Guangdong |
| China | Siping Central People's Hospital-Cardiovascular Department ( Site 3408) | Siping | Jilin |
| China | Suining Central Hospital ( Site 3487) | Suining | Sichuan |
| China | Tianjin People' s Hospital-Cardiology ( Site 3425) | Tianjin | Tianjin |
| China | Chongqing University Three Gorges Hospital ( Site 3441) | Wanzhou | Chongqing |
| China | Pu'ai Hospital of Wuhan City ( Site 3451) | Wuhan | Hubei |
| China | The First Affiliated Hospital of Xi'an Jiaotong University ( Site 3420) | Xi'an | Shaanxi |
| China | Shaanxi provincial people's hospital ( Site 3421) | Xian | Shaanxi |
| China | Xianyang Hospital of Yan'an University ( Site 3435) | Xianyang | Shaanxi |
| China | Northern Jiangsu People's Hospital ( Site 3405) | Yangzhou | Jiangsu |
| China | General Hospital of Ningxia Medical University ( Site 3478) | Yinchuan | Ningxia |
| China | The First People's Hospital of Yueyang-Cardiovascular department ( Site 3448) | Yueyang | Hunan |
| China | Affiliated Hospital of Jiangsu University-Cardiology Department ( Site 3481) | Zhenjiang | Jiangsu |
| China | Zibo Municipal Hospital ( Site 3474) | Zibo | Shandong |
| Colombia | Ciensalud Ips S A S ( Site 0903) | Barranquilla | Atlantico |
| Colombia | Clinica de la Costa S.A.S. ( Site 0902) | Barranquilla | Atlantico |
| Colombia | IPS Centro Científico Asistencial S.A.S ( Site 0900) | Barranquilla | Atlantico |
| Colombia | Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0920) | Bogota | Cundinamarca |
| Colombia | Fundacion Santa Fe de Bogota ( Site 0916) | Bogotá | Cundinamarca |
| Colombia | Salud SURA Calle 100 ( Site 0918) | Bogotá | Cundinamarca |
| Colombia | Solano & Terront Servicios Medicos - UNIENDO ( Site 0915) | Bogotá | Cundinamarca |
| Colombia | Centro de Investigaciones Clinicas SAS ( Site 0912) | Cali | Valle Del Cauca |
| Colombia | Fundación Valle del Lili ( Site 0904) | Cali | Valle Del Cauca |
| Colombia | Mediservis del Tolima IPS S.A.S ( Site 0914) | Ibague | Tolima |
| Colombia | IPS Médicos Internistas de Caldas ( Site 0905) | Manizales | Caldas |
| Colombia | Fundación Centro de Investigación Clínica CIC ( Site 0906) | Medellín | Antioquia |
| Colombia | Rodrigo Botero S.A.S ( Site 0901) | Medellín | Antioquia |
| Colombia | Salud SURA Industriales ( Site 0917) | Medellín | Antioquia |
| Colombia | Oncomédica S.A.S ( Site 0907) | Montería | Cordoba |
| Colombia | Fundación Cardiovascular de Colombia ( Site 0911) | Piedecuesta | Santander |
| Colombia | Instituto Cardiovascular del Cesar S.A ( Site 0919) | Valledupar | Cesar |
| Colombia | Healthy Medical Center S.A.S ( Site 0913) | Zipaquira | Cundinamarca |
| Hong Kong | Queen Mary Hospital-Medicine - Cardiology ( Site 3303) | Hksar | |
| Hong Kong | Queen Mary Hospital-Medical ( Site 3300) | Pok Fu Lam | |
| Hong Kong | Prince of Wales Hospital ( Site 3301) | Shatin | |
| Hong Kong | Prince of Wales Hospital ( Site 3304) | Shatin | |
| Israel | Barzilai Medical Center ( Site 1713) | Ashkelon | |
| Israel | Soroka Medical Center ( Site 1715) | Be'er Sheva | |
| Israel | Hillel Yaffe Medical Center ( Site 1705) | Hadera | |
| Israel | Linn Medical Center ( Site 1711) | Haifa | |
| Israel | Rambam Health Care Campus ( Site 1702) | Haifa | |
| Israel | Rambam Health Care Campus ( Site 1718) | Haifa | |
| Israel | Institute of Diabetes, Technology and Research - Clalit Health ( Site 1701) | Herzliya | |
| Israel | Clalit health Services - Holon Medical Center ( Site 1721) | Holon | |
| Israel | Hadassah Medical Center ( Site 1706) | Jerusalem | |
| Israel | Hadassah Medical Center ( Site 1709) | Jerusalem | |
| Israel | Shaare Zedek Medical Center ( Site 1710) | Jerusalem | |
| Israel | Rabin Medical Center ( Site 1703) | Petah Tikva | |
| Israel | Rabin Medical Center ( Site 1720) | Petah Tikva | |
| Israel | Sheba Medical Center ( Site 1708) | Ramat Gan | |
| Israel | Clalit Health Services - Sakhnin Community Clinic-Research Unit ( Site 1700) | Sakhnin | |
| Japan | Tokyonishi Tokushukai Hospital ( Site 3530) | Akishima | Tokyo |
| Japan | Fujisawa City Hospital ( Site 3522) | Fujisawa | Kanagawa |
| Japan | Fukuoka University Hospital ( Site 3502) | Fukuoka | |
| Japan | Japanese Red Cross Fukuoka Hospital ( Site 3528) | Fukuoka | |
| Japan | Saiseikai Fukuoka General Hospital ( Site 3536) | Fukuoka | |
| Japan | Minamino Cardiovascular Hospital ( Site 3546) | Hachioji | Tokyo |
| Japan | Hanyu General Hospital ( Site 3504) | Hanyu | Saitama |
| Japan | Affiliated Central Clinic of Higashiyamato Hospital ( Site 3533) | Higashiyamato-shi | Tokyo |
| Japan | Hyogo Prefectural Harima-Himeji General Medical Center ( Site 3514) | Himeji | Hyogo |
| Japan | Shonan Kamakura General Hospital ( Site 3516) | Kamakura | Kanagawa |
| Japan | Fukuoka Tokushukai Hospital ( Site 3511) | Kasuga | Fukuoka |
| Japan | Saiseikai Kumamoto Hospital ( Site 3515) | Kumamoto | |
| Japan | Seikeikai Medical Corporation New Tokyo Heart Clinic ( Site 3537) | Matsudo | Chiba |
| Japan | Nagasaki Harbor Medical Center ( Site 3527) | Nagasaki | |
| Japan | Okayama City General Medical Center Okayama City Hospital ( Site 3508) | Okayama | |
| Japan | National Hospital Organization Nagasaki Medical Center ( Site 3505) | Omura | Nagasaki |
| Japan | Saga-Ken Medical Centre Koseikan ( Site 3543) | Saga-shi | Saga |
| Japan | Saitama City Hospital ( Site 3535) | Saitama | |
| Japan | Sanai Hospital - Saitama ( Site 3532) | Saitama | |
| Japan | Kagawa Prefectural Central Hospital ( Site 3538) | Takamatsu | Kagawa |
| Japan | TAKAMATSU Red Cross Hospital ( Site 3506) | Takamatsu-shi | Kagawa |
| Japan | Machida Municipal Hospital ( Site 3545) | Tokyo | |
| Japan | Uji-Tokushukai Medical Center ( Site 3509) | Uji | Kyoto |
| Korea, Republic of | Keimyung University Dongsan Hospital ( Site 3003) | Daegu | Taegu-Kwangyokshi |
| Korea, Republic of | Seoul National University Bundang Hospital ( Site 3005) | Seongnam | Kyonggi-do |
| Korea, Republic of | Asan Medical Center ( Site 3004) | Seoul | |
| Korea, Republic of | Samsung Medical Center-cardiology ( Site 3000) | Seoul | |
| Korea, Republic of | Seoul National University Hospital ( Site 3001) | Seoul | |
| Korea, Republic of | Severance Hospital, Yonsei University Health System ( Site 3002) | Seoul | |
| Korea, Republic of | The Catholic Univ. of Korea Seoul St. Mary's Hospital ( Site 3007) | Seoul | |
| Korea, Republic of | Ajou University Hospital ( Site 3006) | Suwon | Kyonggi-do |
| Mexico | Centro de Atención e Investigación Clínica ( Site 1010) | Aguascalientes | |
| Mexico | ICARO Investigaciones en Medicina ( Site 1005) | Chihuahua | |
| Mexico | Bio Investigación AMARC, S.C. ( Site 1013) | Ciudad de México | Distrito Federal |
| Mexico | Centro de Investigación Médico Biológica y Terapia Avanzada ( Site 1021) | Guadalajara | Jalisco |
| Mexico | Instituto Jalisciense de Investigacion en Diabetes y Obesidad-Endocrinology ( Site 1007) | Guadalajara | Jalisco |
| Mexico | Centro de Imagen y Tecnología en Intervención Cardiovascular-Research ( Site 1041) | Mexico City | Distrito Federal |
| Mexico | Unidad biomedica avanzada monterrey-Clinical Trials ( Site 1000) | Monterrey | Nuevo Leon |
| Mexico | Arké SMO S.A de C.V ( Site 1026) | Veracruz | |
| New Zealand | Auckland City Hospital ( Site 2911) | Auckland | |
| New Zealand | New Zealand Clinical Research (Auckland) ( Site 2900) | Auckland | |
| New Zealand | New Zealand Clinical Research (Christchurch) ( Site 2901) | Christchurch | Canterbury |
| New Zealand | Pacific Clinical Research Network - Forte ( Site 2903) | Christchurch | Canterbury |
| New Zealand | Lakeland Clinical Trials Wellington ( Site 2904) | Ebdentown | Wellington |
| New Zealand | Lakeland Clinical Trials Waikato ( Site 2906) | Nawton | Waikato |
| New Zealand | Southern Clinical Trials Tasman ( Site 2905) | Nelson | |
| New Zealand | P3 Research - Palmerston North ( Site 2909) | Palmerston North | Manawatu-Wanganui |
| New Zealand | Pacific Clinical Research Network - Rotorua ( Site 2902) | Rotorua | Bay Of Plenty |
| New Zealand | P3 Research - Tauranga ( Site 2907) | Tauranga | Bay Of Plenty |
| Peru | Hogar Clínica San Juan de Dios ( Site 1115) | Arequipa | Ariqipa |
| Peru | Clínica El Golf-Cardiologia ( Site 1103) | Lima | |
| Peru | Clínica Internacional - Sede San Borja ( Site 1111) | Lima | |
| Peru | Clínica Javier Prado ( Site 1100) | Lima | |
| Peru | Clínica Providencia ( Site 1102) | Lima | |
| Peru | Clínica Vesalio-Cardiology ( Site 1101) | Lima | |
| Peru | Hospital Militar Geriátrico ( Site 1114) | Lima | |
| Peru | ASOCIACION CIVIL POR LA SALUD ( Site 1107) | Miraflores | Muni Metro De Lima |
| Peru | Centro de Investigación Clínica Belén ( Site 1108) | Piura | |
| Peru | Instituto Médico Soy Diabetico ( Site 1106) | Piura | |
| Peru | Centro de investigacion Clínica Trujillo-Medical specialties ( Site 1104) | Trujillo | La Libertad |
| Taiwan | Changhua Christian Hospital ( Site 3101) | Changhua County | Changhua |
| Taiwan | Chang Gung Memorial Hospital at Kaohsiung ( Site 3102) | Kaohsiung Niao Sung Dist | Kaohsiung |
| Taiwan | Mackay Memorial Hospital -Tamshui Branch ( Site 3108) | New Taipei City | New Taipei |
| Taiwan | China Medical University Hospital ( Site 3103) | Taichung | |
| Taiwan | Chi Mei Medical Center-Cardiology ( Site 3104) | Tainan City | Tainan |
| Taiwan | National Taiwan University Hospital ( Site 3100) | Taipei | |
| Taiwan | Taipei Medical University Hospital-Cardiology ( Site 3107) | Taipei | |
| Taiwan | Taipei Veterans General Hospital ( Site 3106) | Taipei | |
| Turkey | Hacettepe Universite Hastaneleri ( Site 2500) | Altindag | Ankara |
| Turkey | Ankara Bilkent Sehir Hastanesi-cardiology ( Site 2501) | Ankara | |
| Turkey | Antalya Egitim ve Arastirma Hastanesi-Cardiology ( Site 2518) | Antalya | |
| Turkey | Ege Universitesi Hastanesi-Cardilogy Department ( Site 2502) | Bornova | Izmir |
| Turkey | Trakya University ( Site 2523) | Edirne | |
| Turkey | Eskisehir Osmangazi University-Cardiology ( Site 2510) | Eskisehir | |
| Turkey | Kocaeli Üniversitesi-Cardiology ( Site 2516) | Kocaeli | |
| United Kingdom | West Walk Surgery ( Site 2602) | Bristol | Bristol, City Of |
| United Kingdom | Golden Jubilee National Hospital ( Site 2613) | Clydebank | Glasgow City |
| United Kingdom | Lakeside Surgery ( Site 2601) | Corby | Northamptonshire |
| United Kingdom | Royal Devon & Exeter Hospital-Patient Recruitment Centre: Exeter ( Site 2605) | Exeter | Devon |
| United Kingdom | Barts Health NHS Trust-William Harvey Clinical Research Centre ( Site 2603) | London | England |
| United Kingdom | Campus for Ageing and Vitality ( Site 2606) | Newcastle upon Tyne | |
| United Kingdom | Northern General Hospital ( Site 2611) | Sheffield | |
| United Kingdom | Walsall Manor Hospital ( Site 2600) | Walsall | |
| United States | New Mexico Clinical Research & Osteoporosis Center ( Site 0005) | Albuquerque | New Mexico |
| United States | Advanced Cardiovascular - Alexander City ( Site 0156) | Alexander City | Alabama |
| United States | Velocity Clinical Research, Anderson ( Site 0022) | Anderson | South Carolina |
| United States | University of Colorado Anschutz Medical Campus-University of Colorado Hospital Cardiac and Vascular | Aurora | Colorado |
| United States | Northeast Cardiology Associates ( Site 0168) | Bangor | Maine |
| United States | Westside Medical Associates of Los Angeles-Research ( Site 0077) | Beverly Hills | California |
| United States | Velocity Clinical Research, Binghamton ( Site 0063) | Binghamton | New York |
| United States | Central Alabama Research ( Site 0109) | Birmingham | Alabama |
| United States | Central Research Associates ( Site 0118) | Birmingham | Alabama |
| United States | Excel Medical Clinical Trials ( Site 0052) | Boca Raton | Florida |
| United States | Boston Clinical Trials ( Site 0029) | Boston | Massachusetts |
| United States | Advanced Heart Care - Bridgewater Route 22 ( Site 0160) | Bridgewater | New Jersey |
| United States | Holston Medical Group ( Site 0106) | Bristol | Tennessee |
| United States | Burke Internal Medicine and Research ( Site 0035) | Burke | Virginia |
| United States | Capital Area Research, LLC ( Site 0139) | Camp Hill | Pennsylvania |
| United States | Charlottesville Medical Research ( Site 0030) | Charlottesville | Virginia |
| United States | Great Lakes Clinical Trials - Ravenswood ( Site 0056) | Chicago | Illinois |
| United States | Synexus Clinical Research US, Inc. ( Site 0084) | Chicago | Illinois |
| United States | Velocity Clinical Research, Springdale ( Site 0112) | Cincinnati | Ohio |
| United States | Avant Research Associates ( Site 0103) | Crowley | Louisiana |
| United States | Advanced Pharma Research ( Site 0040) | Cutler Bay | Florida |
| United States | Alliance for Multispecialty Research, LLC ( Site 0076) | Daphne | Alabama |
| United States | Premier Cardiovascular Institute ( Site 0136) | Dayton | Ohio |
| United States | Alliance for Multispecialty Research, LLC. ( Site 0171) | Dearborn | Michigan |
| United States | Skyline Medical Center/CCT Research ( Site 0148) | Elkhorn | Nebraska |
| United States | Alliance for Multispecialty Research - Medisphere Medical Research Center ( Site 0080) | Evansville | Indiana |
| United States | Virginia Heart ( Site 0097) | Falls Church | Virginia |
| United States | Lillestol Research ( Site 0025) | Fargo | North Dakota |
| United States | Healthcare Research Network - Chicago ( Site 0051) | Flossmoor | Illinois |
| United States | G&L Research ( Site 0042) | Foley | Alabama |
| United States | Alliance for Multispecialty Research, LLC ( Site 0083) | Fort Myers | Florida |
| United States | Parkview Research Center at Parkview Regional Medical Center ( Site 0154) | Fort Wayne | Indiana |
| United States | Healthy Heart Cardiology ( Site 0113) | Grand Rapids | Michigan |
| United States | Velocity Clinical Research, Gulfport ( Site 0038) | Gulfport | Mississippi |
| United States | Great Lakes Clinical Trials - Gurnee ( Site 0134) | Gurnee | Illinois |
| United States | Healthcare Research Network - St. Louis ( Site 0053) | Hazelwood | Missouri |
| United States | Prolato Clinical Research Center ( Site 0108) | Houston | Texas |
| United States | Franciscan Physician Network - Indiana Heart Physicians ( Site 0141) | Indianapolis | Indiana |
| United States | East Coast Institute for Research, LLC ( Site 0031) | Jacksonville | Florida |
| United States | Jacksonville Center for Clinical Research ( Site 0048) | Jacksonville | Florida |
| United States | University of Florida - Jacksonville ( Site 0166) | Jacksonville | Florida |
| United States | Westside Center for Clinical Research ( Site 0049) | Jacksonville | Florida |
| United States | Alliance for Multispecialty Research, LLC ( Site 0071) | Kansas City | Missouri |
| United States | University of Kansas Medical Center ( Site 0004) | Kansas City | Kansas |
| United States | Holston Medical Group ( Site 0047) | Kingsport | Tennessee |
| United States | Alliance for Multispecialty Research, LLC ( Site 0008) | Knoxville | Tennessee |
| United States | UCSD - Altman Clinical and Translational Research Institute (ACTRI) ( Site 0130) | La Jolla | California |
| United States | East Coast Institute for Research ( Site 0034) | Lake City | Florida |
| United States | Chemidox Clinical Trials ( Site 0145) | Lancaster | California |
| United States | Clinical Research of South Nevada ( Site 0135) | Las Vegas | Nevada |
| United States | Excel Clinical Research, LLC ( Site 0123) | Las Vegas | Nevada |
| United States | Alliance for Multispecialty Research, LLC ( Site 0027) | Lexington | Kentucky |
| United States | Velocity Clinical Research at The Pioneer Heart Institute, Lincoln ( Site 0078) | Lincoln | Nebraska |
| United States | South Denver Cardiology Associates ( Site 0167) | Littleton | Colorado |
| United States | Velocity Clinical Research, Westlake ( Site 0039) | Los Angeles | California |
| United States | L-MARC Research Center ( Site 0001) | Louisville | Kentucky |
| United States | East Coast Institute for Research, LLC ( Site 0032) | Macon | Georgia |
| United States | Carient Heart & Vascular - Manassas ( Site 0170) | Manassas | Virginia |
| United States | Manassas Clinical Research Center ( Site 0007) | Manassas | Virginia |
| United States | Central New York Clinical Research ( Site 0044) | Manlius | New York |
| United States | Fairview Health Services ( Site 0024) | Maplewood | Minnesota |
| United States | Columbus Clinical Services ( Site 0026) | Miami | Florida |
| United States | Inpatient Research Clinic ( Site 0041) | Miami Lakes | Florida |
| United States | Eminat ( Site 0082) | Miramar | Florida |
| United States | IMA Clinical Research- Monroe- North 18th Street ( Site 0111) | Monroe | Louisiana |
| United States | North Shore Diabetes & Endocrine Associates ( Site 0165) | New Hyde Park | New York |
| United States | Mid Hudson Medical Research ( Site 0087) | New Windsor | New York |
| United States | Health Research of Hampton Roads, Inc. ( Site 0043) | Newport News | Virginia |
| United States | Alliance for Multispecialty Research, LLC ( Site 0068) | Norfolk | Virginia |
| United States | Coastal Carolina Research Center ( Site 0006) | North Charleston | South Carolina |
| United States | Ocala Research Institute - Ocala - Southwest 20th Place ( Site 0079) | Ocala | Florida |
| United States | Permian Research Foundation ( Site 0157) | Odessa | Texas |
| United States | South Oklahoma Heart Research ( Site 0164) | Oklahoma City | Oklahoma |
| United States | Carbon Health - Pasadena ( Site 0149) | Pasadena | California |
| United States | LinQ Research ( Site 0101) | Pearland | Texas |
| United States | Synexus Clinical Research US, Inc.-Synexus Clinical Research US, Inc - Central Phoenix ( Site 0066) | Phoenix | Arizona |
| United States | Progressive Medical Research ( Site 0045) | Port Orange | Florida |
| United States | Monument Health Clinical Research, a department of Monument -Monument Health Clinical Research, a d | Rapid City | South Dakota |
| United States | Rochester Clinical Research, Inc. ( Site 0098) | Rochester | New York |
| United States | Laurelton Heart Specialist PC ( Site 0092) | Rosedale | New York |
| United States | St Johns Center for Clinical Research ( Site 0016) | Saint Augustine | Florida |
| United States | Highland Clinical Research ( Site 0122) | Salt Lake City | Utah |
| United States | Synexus Clinical Research US, Inc. ( Site 0086) | Salt Lake City | Utah |
| United States | Discovery Clinical Trials ( Site 0096) | San Antonio | Texas |
| United States | Northeast Clinical Research of San Antonio ( Site 0011) | San Antonio | Texas |
| United States | Carbon Health - San Mateo - Hillsdale Mall ( Site 0151) | San Mateo | California |
| United States | Cardiology Associates of Fairfield County, P.C. ( Site 0159) | Stamford | Connecticut |
| United States | Centricity Research Suffolk Primary Care ( Site 0105) | Suffolk | Virginia |
| United States | Sugar Lakes Family Practice, PA ( Site 0094) | Sugar Land | Texas |
| United States | America Clinical Trials-Research Dept ( Site 0104) | Tarzana | California |
| United States | Premiere Medical Center ( Site 0093) | Toluca Lake | California |
| United States | Northwest Houston Heart Center-Northwest Houston Clinical Research, PLLC ( Site 0158) | Tomball | Texas |
| United States | Cotton O'Neil Clinical Research Center ( Site 0095) | Topeka | Kansas |
| United States | Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center ( Site 0058) | Torrance | California |
| United States | Arcturus Healthcare , PLC, Troy Internal Medicine Research Division ( Site 0003) | Troy | Michigan |
| United States | Emerson Clinical Research Institute ( Site 0143) | Washington | District of Columbia |
| United States | Cardiovascular Associates of the Delaware Valley ( Site 0162) | Washington Township | New Jersey |
| United States | Chase Medical Research, LLC ( Site 0046) | Waterbury | Connecticut |
| United States | Velocity Clinical Research, Salt Lake City ( Site 0019) | West Jordan | Utah |
| United States | Alliance for Multispecialty Research, LLC ( Site 0116) | Wichita | Kansas |
| United States | Wake Forest Baptist Health-Cardiovascular Medicine ( Site 0142) | Winston-Salem | North Carolina |
| United States | Clinical Site Partners LLC, dba CSP Orlando ( Site 0067) | Winter Park | Florida |
| United States | North Georgia Clinical Research ( Site 0128) | Woodstock | Georgia |
| United States | Cardiology Consultants of Philadelphia Yardley ( Site 0072) | Yardley | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Merck Sharp & Dohme LLC |
United States, Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Hong Kong, Israel, Japan, Korea, Republic of, Mexico, New Zealand, Peru, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to First Occurrence of Coronary Heart Disease (CHD) Death-Based Major Adverse Cardiovascular Events (MACE)-Plus | Time to the first occurrence of CHD death-based MACE-plus, which is defined as any of the following: coronary heart disease death, myocardial infarction (MI), ischemic stroke (fatal and nonfatal), acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral). | From date of randomization until the date of first occurrence of CHD death-based MACE-plus, assessed up to approximately 6 years | |
| Secondary | Time to First Occurrence of 3-point MACE | Time to the first occurrence of 3-point MACE (defined as cardiovascular death, MI, or ischemic stroke). | From date of randomization until the date of first occurrence of 3-point MACE, assessed up to approximately 6 years | |
| Secondary | Time to First Occurrence of Cardiovascular (CV) Death-Based MACE Plus | Time to the first occurrence of CV death-based MACE plus, defined as any of the following: cardiovascular death, MI, ischemic stroke, acute limb ischemia or major amputation, or urgent arterial revascularization (coronary, cerebrovascular, or peripheral). | From date of randomization until the date of first occurrence of CV death-based MACE plus, assessed up to approximately 6 years | |
| Secondary | Time to First Occurrence of CHD Death or MI | Time to the first occurrence of CHD death or MI. | From date of randomization until the date of first occurrence of CHD death or MI, assessed up to approximately 6 years | |
| Secondary | Time to CV Death | Time to cardiovascular death. | From date of randomization until the date of CV death, assessed up to approximately 6 years | |
| Secondary | Time to All-Cause Death | Time to all-cause death. | From date of randomization until the date of death, assessed up to approximately 6 years | |
| Secondary | Time to CHD Death | Time to CHD death. | From date of randomization until the date of CHD death, assessed up to approximately 6 years | |
| Secondary | Time to First Event of MI | Time to the first occurrence of MI. | From date of randomization until the date of MI, assessed up to approximately 6 years | |
| Secondary | Time to First Event of Ischemic Stroke | Time to the first occurrence of ischemic stroke. | From date of randomization until the date of first occurrence of ischemic stroke, assessed up to approximately 6 years | |
| Secondary | Time to First Event of Acute Limb Ischemia or Major Amputation | Time to the first occurrence of acute limb ischemia or major amputation. | From date of randomization until the date of first occurrence of acute limb ischemia or major amputation, assessed up to approximately 6 years | |
| Secondary | Time to First Event of Urgent Arterial Revascularization | Time to the first occurrence of urgent arterial revascularization (coronary, cerebrovascular, or peripheral). | From date of randomization until the date of urgent arterial revascularization, assessed up to approximately 6 years | |
| Secondary | Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) | The percent change from baseline in LDL-C. | Baseline and Week 52 | |
| Secondary | Percent Change from Baseline in Apolipoprotein B | The percent change from baseline in apolipoprotein B. | Baseline and Week 52 | |
| Secondary | Percent Change from Baseline in Non-High-Density Lipoprotein Cholesterol (non-HDL-C) cholesterol | The percent change from baseline in Non-HDL-C. | Baseline and Week 52 | |
| Secondary | Percent Change from Baseline in Lipoprotein (a) | The percent change from baseline in lipoprotein (a). | Baseline and Week 52 | |
| Secondary | Number of Participants with an Adverse Event (AE) | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants with AE(s) in each arm will be reported. | Up to ~6 years | |
| Secondary | Number of Participants Discontinuing from Study Therapy Due to AE | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants discontinuing due to AE(s) in each arm will be reported. | Up to ~6 years |
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