Study Description
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligram (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo. The purpose of this study is to evaluate inclisiran sodium 300 mg s.c. (equivalent to 284 mg inclisiran) compared to placebo on reducing the risk of 4P-MACE in adult patients at high risk for their first major adverse cardiovascular event.
Randomized participants will receive study medication (inclisiran or placebo), administered s.c. on Day 1, Day 90, then every 6 months thereafter. This is an event-driven study. Therefore, the study will continue until the required number of clinical events have occurred across both treatment arms, and all participants have a minimum of 3 years of follow-up during the double-blind treatment period.
Interventions
Inclisiran sodium 300 mg (equivalent to 284 mg inclisiran) in 1.5 mL
Placebo in 1.5ml
Eligibility Criteria
Inclusion Criteria:
* At an increased risk for a first MACE (i.e., no prior major ASCVD event), defined as any one of the following:
1. Evidence of atherosclerotic coronary artery disease (CAD) on computer tomography (CT) or invasive coronary angiogram defined as a coronary artery stenosis ≥20% but \<50% in the left main coronary artery or stenosis ≥20% but \<70% in any other major epicardial coronary artery, or
2. Coronary artery calcium (CAC) score obtained by CT-scan ≥100 Agatston units, or
3. High 10-year ASCVD risk ≥20%, or
4. Intermediate 10-year ASCVD risk 7.5% - \<20% with at least 2 risk-enhancing factors.
* LDL-C ≥70 mg/dL (≥1.81 mmol/L) but \<190 mg/dL (\<4.91 mmol/L) at the screening visit. If on a background lipid lowering therapy, the dose should be stable for at least 4 weeks prior to the screening visit and the participant should be willing to remain on this background therapy for the entire duration of the study.
Exclusion Criteria:
* History of major ASCVD event.
* History of, or planned, ischemia-driven revascularization in a coronary or extracoronary arterial bed prior to randomization
* Absence of coronary atherosclerosis on a CT angiogram or an invasive coronary angiogram in the 2 years prior to randomization
* Coronary artery calcium (CAC) score of 0 obtained in the 2 years prior to randomization
* Active liver disease or hepatic dysfunction
* Previous, current, or planned treatment with a monoclonal antibody (mAb) directed toward proprotein convertase subtilisin/kexin type 9 (PCSK9) (e.g., evolocumab, alirocumab)
* Pregnant or nursing (lactating) women
* Women of childbearing potential unless they are using effective methods of contraception while taking study treatment which includes for 6 months after last study drug administration
Other protocol-defined inclusion/exclusion criteria may apply.
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Ciudad de Buenos Aires,C1426,Argentina
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Caba,Buenos Aires,C1414aif,Argentina
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Cordoba,X5000,Argentina
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Ciudad Autonoma de Bs As,Buenos Aires,C1015abo,Argentina
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Parana,3100,Argentina
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Ciudad de Formosa,Formosa,P3600,Argentina
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Tucuman,San Miguel De Tucuman,T4000icl,Argentina
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Rosario,Santa Fe,S200cvd,Argentina
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Buenos Aires,W3400abh,Argentina
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Caba,Buenos Aires,C1405bch,Argentina
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Heidelberg,Victoria,3084,Australia
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Concord,New South Wales,2139,Australia
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Malvern East,Victoria,3145,Australia
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Sippy Downs,Queensland,4556,Australia
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Joondalup,Western Australia,6027,Australia
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Woolloongabba,Queensland,4102,Australia
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Adelaide,South Australia,5000,Australia
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Hobart,Tasmania,7000,Australia
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Clayton,Victoria,3168,Australia
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Camperdown,New South Wales,2050,Australia
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Genk,3600,Belgium
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Hasselt,3500,Belgium
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Mechelen,2800,Belgium
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Porto Alegre,RS,90560 030,Brazil
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Belo Horizonte,MG,30140 062,Brazil
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Sao Paulo,SP,01323001,Brazil
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Salvador,BA,40170-130,Brazil
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Blumenau,Santa Catarina,89020 430,Brazil
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Belo Horizonte,MG,30150-320,Brazil
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Salvador,BA,41820-011,Brazil
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Santo Andre,Sao Paulo,09030-010,Brazil
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Uberlandia,Minas Gerais,38400 500,Brazil
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Herning,7400,Denmark
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Petach Tikva,4941492,Israel
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Riga,Lv-1001,Latvia
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Ogre,LV,5001,Latvia
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Kaunas,Kauno Apskritis,50161,Lithuania
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Panevezys,35144,Lithuania
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Seri Manjung,Perak,32040,Malaysia
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Alor Setar,Kedah,05460,Malaysia
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Monterrey,Nuevo Leon,64440,Mexico
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Veracruz,91900,Mexico
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Guadalajara,Jalisco,44260,Mexico
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Aguascalientes,20230,Mexico
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Chihuahua,31238,Mexico
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Guadalajara,Jalisco,44670,Mexico
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Distrito Federal,03100,Mexico
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Cuauhtemoc,Cdmx,06760,Mexico
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Mexico,Distrito Federal,14080,Mexico
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Tampico,Tamaulipas,89440,Mexico
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Monterrey,Nuevo Leon,64020,Mexico
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Mexico D F,06720,Mexico
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Ciudad de Mexico,Distrito Federal,06700,Mexico
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Merida,Yucatan,97070,Mexico
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San Luis Potosi,78200,Mexico
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Aguascalientes,20116,Mexico
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Amsterdam,1105 az,Netherlands
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San Juan City,1500,Philippines
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Manila,1000,Philippines
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Iloilo,5000,Philippines
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Quezon,1102,Philippines
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Santa Maria da Feira,4520 211,Portugal
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Setubal,2910-446,Portugal
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Carnaxide,Lisboa,2799 523,Portugal
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Almada,2801 951,Portugal
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Lisboa,1649 035,Portugal
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Coimbra,3000 075,Portugal
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Matosinhos,4454 513,Portugal
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Lisboa,1500 650,Portugal
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Porto,4200 319,Portugal
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Cluj Napoca,400006,Romania
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Baia Mare,430123,Romania
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Lasi,700544,Romania
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Baia Mare,430222,Romania
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Pitesti,Arges,110438,Romania
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Targu Mures,540142,Romania
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Braila,810249,Romania
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Oradea,Bihor,410001,Romania
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Targu Mures,540143,Romania
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Bucharest,021875,Romania
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Targu Mures,Mures,540124,Romania
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Tirgoviste,130095,Romania
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Bucharest,050098,Romania
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Targu Mures,Mures,540136,Romania
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Buzau,120133,Romania
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Timisoara,Timis,300041,Romania
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Singapore,169608,Singapore
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Bratislava,813 69,Slovakia
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Bratislava,83106,Slovakia
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Bratislava,84104,Slovakia
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Malacky,90122,Slovakia
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Nitra,949 01,Slovakia
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Cape Town,Western Cape,7500,South Africa
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Western Cape,7130,South Africa
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Cape Town,ZAF,7570,South Africa
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Cape Town,7531,South Africa
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Port Elizabeth,Eastern Cape,6001,South Africa
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Pretoria,Gauteng,0184,South Africa
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Antequera,Malaga,29200,Spain
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Marbella,Andalucia,29600,Spain
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Uppsala,75237,Sweden
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Malmo,Skane Lan,21152,Sweden
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Vasteras,721 89,Sweden
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Goteborg,405 45,Sweden
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Linkoping,58213,Sweden
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Lund,22221,Sweden
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Solna,171 64,Sweden
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Stockholm,111 57,Sweden
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Tainan,704,Taiwan
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Tainan,71004,Taiwan
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Taipei,110,Taiwan
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Taichung,Taiwan ROC,40201,Taiwan
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Taipei,11217,Taiwan
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Changhua,50006,Taiwan
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Taoyuan,33305,Taiwan
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Kaohsiung,80756,Taiwan
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Taichung,40447,Taiwan
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Khon Kaen,THA,40002,Thailand
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Muang,12120,Thailand
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Bangkok,10330,Thailand
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Ubon Ratchathani,34000,Thailand
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Bangkok,10400,Thailand
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Bangkok,10700,Thailand
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Songkhla,Hat Yai,90110,Thailand
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Chiang Mai,50200,Thailand
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Izmir,35100,Turkey
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Izmir,35340,Turkey
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Mersin,33110,Turkey
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Izmir,Bayrakli,35540,Turkey
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Mugla,48000,Turkey
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Denizli,20070,Turkey
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Gaziantep,27310,Turkey
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Haydarpasa Istanbul,34668,Turkey
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Wirrel,Ch62 6ee,United Kingdom
Trident Cardiology
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Ladson,South Carolina,29465,United States
Frederick Funke
Elite Clinical Research LLC Cardio
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Jackson,Mississippi,39211,United States
Honey East
James A Haley Veterans Hospital
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Tampa,Florida,33612,United States
David Whitaker
Lenzmeier Family Practice
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Glendale,Arizona,85308,United States
Thomas Lenzmeier
Synexus Clinical Research US Inc
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Cincinnati,Ohio,45236,United States
Linda Brotherton
Paul Nugent
Cary Research Group .
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Cary,North Carolina,27511,United States
Sunil Desai
Cole Ocker
Research Integrity LLC
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Owensboro,Kentucky,42303,United States
Kishor Vora
Northwest Houston Clinical Research PLLC
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Tomball,Texas,77375,United States
Shamaila Aslam
Blue Coast Research Center LLC .
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Vista,California,92081,United States
Kareem Wehba
Hanh Bui
New Jersey Heart
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Linden,New Jersey,07036,United States
Jasjit S Walia
Northwest Heart Clinical Rsrch LLC .
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Arlington Heights,Illinois,60005,United States
Roger Nissen
Biopharma Informatic LLC .
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Houston,Texas,77084,United States
Humayun Naqvi
National Heart Institute
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Beverly Hills,California,90211,United States
Norman Lepor
Hightower Clinical Research Central Ok Early Detection Ctr
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Oklahoma City,Oklahoma,73134,United States
Susan Dimick
Monroe Research Llc Research
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West Monroe,Louisiana,71291,United States
Assad Mouhaffel
Carient Heart and Vascular
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Manassas,Virginia,20109,United States
Hamid Taheri
Meridian International Research
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Miami Gardens,Florida,33014,United States
Renato Carlos Dominguez
Gonzalo Quesada
Velia Salgado
Wellmont CVA Heart Institute
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Greenville,Tennessee,37745,United States
Jack Whitaker
Uni of California at Los Angeles
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Torrance,California,90502,United States
Matthew Jay Budoff
Synexus Clinical Research US Inc
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Anderson,South Carolina,29621,United States
James Kopp
AA Medical Research Center
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Flint,Michigan,48504,United States
Ahmed Arif
Fam Medical Specialists Of Fl Plc
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Plant City,Florida,33563,United States
Michael Gimness
Theresa Frost
The Center for Clinical Trials
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Saraland,Alabama,36571,United States
Howard Rubenstein
Janice Orr
Hudson Valley Urology Cardiovascular Practice
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Poughkeepsie,New York,12601,United States
Sunny Suresh Intwala
Camille Finkle
Hutchinson Clinic
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Hutchinson,Kansas,67502,United States
James Ruhlmann
Consano Clinical Research LLC
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Shavano Park,Texas,78231,United States
Michelle Welch
Care Access Rapid City
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Rapid City,South Dakota,57701,United States
Ali Bajwa
Bhaskar Purushottam
Buffi Green
Lincoln Internal Medicine Associates
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Lincoln,Nebraska,68516,United States
Jason R Potts
Atlanta Heart Specialists LLC
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Tucker,Georgia,30084,United States
David Suh
Clinical Research Advantage Fiel Family and Sports Med, PC
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Tempe,Arizona,85283,United States
Thomas Fiel
Primed Clinical Research Research
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Dayton,Ohio,45429,United States
William Randall
Eva Collins
Adv Imaging Prev and Clin Research Cardio
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Wilmington,North Carolina,28401,United States
Matthew Janik
Rebecca Blackburn
Barnum Medical Research Inc .
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Natchitoches,Louisiana,71457,United States
Otis R. Barnum
Virginia Heart CLCZ696G2301
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Falls Church,Virginia,22042,United States
Subash Bazaz
Tariq Haddad
Cynthia E Alvarez
University of Florida Health Science Center Main Centre
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Jacksonville,Florida,32209,United States
Francesco Franchi
New York Presbyterian Queens .
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Flushing,New York,11355,United States
Sijun Kim
Beacon Health System
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Elkhart,Indiana,46514,United States
Troy Weirick
Julie Large
Discovery Clinical Trials .
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Pflugerville,Texas,78660-3015,United States
Brian K MacGillivray
Acclaim Clinical Research
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San Diego,California,92120,United States
John Beckes
Allegheny General Hospital
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Pittsburgh,Pennsylvania,15212,United States
Andrew Oehler
Johns Hopkins University
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Columbia,Maryland,21044,United States
Daniel Kim
MultiCare Ins Research Innovation
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Puyallup,Washington,98372,United States
Ahmad Slim
Tennessee Center For Clinical Trials
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Tullahoma,Tennessee,37388,United States
Dinesh Gupta
Excel Medical Clinical Trials LLC
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Boca Raton,Florida,33434,United States
Seth J Baum
VAMC Research-G V Sonny Montgomery Clinic .
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Jackson,Mississippi,39216,United States
Sarah Joiner
Cone Health Cancer Center
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Greensboro,North Carolina,27403,United States
Bridgette Christopher
Comprehensive Center Research
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Weslaco,Texas,78596,United States
Eduardo Luna
Eva Woods
University of Illinois at Chicago Cardio
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Chicago,Illinois,60612,United States
David Tofovic
Charles R Drew University of Medicine and Science
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Los Angeles,California,90059,United States
Arnel Joaquin
South Oklahoma Heart Research LLC
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Oklahoma City,Oklahoma,73135,United States
Kay Springer
Naeem Tahirkheli
Southern Clinical Research
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Zachary,Louisiana,70791,United States
Ernest Thompson
Endocrine Associates of Long Island P C
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Smithtown,New York,11787,United States
Michael Howard Shanik
Cotton O Neil Clinical Res Center Cotton O Neil Clin Res Ctr
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Topeka,Kansas,66606,United States
Michael Cox
Javara Research
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Stephenville,Texas,76401,United States
Benjamin Marcum
East West Research Institute
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Honolulu,Hawaii,96814,United States
David Fitz-Patrick
Synexus Clinical Research US Inc
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Tucson,Arizona,85741,United States
Judith Brown
Heart House Research Foundation .
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Springfield,Ohio,45504,United States
Akber Mohammed
CV Ins of the South
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Opelousas,Louisiana,70570,United States
siby george ayalloore
IMA Medical Research PC Cardiology
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Kew Gardens,New York,11415,United States
Pam Toler
Tamas Balogh
Franciscan Health Services Research Center
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Indianapolis,Indiana,46237,United States
Atul Chugh
Epic Medical Research
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Red Oak,Texas,75154,United States
Haresh Boghara
San Diego Cardiac Center
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San Diego,California,92123,United States
Jiken Bhatt
Anderson Medical Research Main Center
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Fort Washington,Maryland,20744,United States
Felton Anderson
Confluence Health Hospital
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Wenatchee,Washington,98801,United States
Anton Grasch
Cambridge Medical Trials .
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Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
Main Street Physicians Care
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Little River,South Carolina,29566,United States
Stephen D Grubb
BayCare Health System .
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Tampa,Florida,33705,United States
Van Nguyen
Cognitive Clinical Trials LLC
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Phoenix,Arizona,85044,United States
Kenneth Steil
Cleveland Clinic Foundation A 90
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Cleveland,Ohio,44195,United States
Leslie Sung Hee Cho
Savica Radesic
Albany Medical College
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Albany,New York,12206,United States
Robert S Busch
Flourish Research Research
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Grandwood Park,Illinois,60031,United States
Barbara Hutchinson
Shayna Carter
Clinical Research Solution
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Houston,Texas,77095,United States
Linda Salinas David
Veena Watwe
Manassas Clinical Research Center
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Manassas,Virginia,20110,United States
Nabil Andrawis
Columbia VA Health Care System
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Columbia,South Carolina,29209,United States
Kurt Barringhaus
Troy Internal Medicine Research .
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Troy,Michigan,48098,United States
Heather Papa
Neil J. Fraser
Peace River Cardiovascular Center
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Port Charlotte,Florida,33952,United States
David Allan Hotchkiss
Alaska Heart and Vascular
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Anchorage,Alaska,99508,United States
Jacob Kelly
Lillestol Research LLC .
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Fargo,North Dakota,58103,United States
Michael J. Lillestol
East Coast Institute for Research .
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Jacksonville,Florida,32223,United States
Ashwini Gore
Advanced Heart Care, LLC .
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Bridgewater,New Jersey,08807,United States
Sharan Mahal
Central Alabama Research
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Birmingham,Alabama,35209,United States
Barry McLean
Pharma Tex Research .
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Amarillo,Texas,79106,United States
Ashley Johnson
David Brabham
Frontier Clinical Research LLC
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Smithfield,Pennsylvania,15478,United States
Marcy Goisse
Capitol Cardiology Associates
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Lanham,Maryland,20706,United States
Vineet Venugopal
Medication Management LLC
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Greensboro,North Carolina,27405,United States
Jagadeesh Ganji
Burke Internal Medicine and Research
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Burke,Virginia,22015,United States
Nashwa Gabra
St Louis Heart and Vascular
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Saint Louis,Missouri,63136,United States
George Kichura
Ascension Saint Agnes Heart Care
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Baltimore,Maryland,21229,United States
Martin Albornoz
New Phase Research And Development
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Knoxville,Tennessee,37909,United States
Amanda M Miller
C for Endo Diabetes and MD
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Newhall,California,91321,United States
Sina Tebi
CCT Hatboro Medical Associates
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Hatboro,Pennsylvania,19040,United States
Harris Cohen
Westchester Medical Center
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Valhalla,New York,10595,United States
Anuritha Tirumani
Hasan Ahmad
Kansas Heart Hospital
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Wichita,Kansas,67226,United States
Thomas Ashcom
NRG Wellness Center Javara Inc
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Sugar Land,Texas,77478,United States
Angel Boston
Ronald M Pucillo
Cardiology Associates Medical Group
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Ventura,California,93003,United States
Angelica Medina
Omid Fatemi
Cardiovascular Solutions LLC
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Shreveport,Louisiana,71103,United States
Wenwu Zhang
Kootenai Heart Clinic-Sandpoint
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Sandpoint,Idaho,83864,United States
Emily Kelly
Ronald Jenkins
Amarillo Heart Clin Rsh Inst
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Amarillo,Texas,79124,United States
Joaquin Martinez-Arraras
Cardiovascular Res Found
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Beverly Hills,California,90210,United States
Ronald P Karlsberg
Lynn Health Science Institute
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Oklahoma City,Oklahoma,73112,United States
Ryan Morgan
West Virginia University Hospital
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Morgantown,West Virginia,26506,United States
Sudarshan Balla
Mid Hudson Medical Research PLLC
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New Windsor,New York,12553,United States
Sashi Makam
Buynak Clinical Research PC
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Valparaiso,Indiana,46383,United States
Robert Buynak
Northeast Clinical Research of San Antonio LLC
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San Antonio,Texas,78233,United States
Arthur Guerrero
Encompass Clinical Research
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Spring Valley,California,91978,United States
Hanid Audish
Clinical Research Inst of Arizona
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Sun City West,Arizona,85375,United States
Jalal Abbas
Synexus Clinical Research
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Columbus,Ohio,43212,United States
Cathy Greiwe
Avant Research Associates LLC
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Crowley,Louisiana,70526,United States
Satinder Saini
Javara Research .
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Fayetteville,Georgia,30214,United States
Charles Kemp
Jessica Kent
Virginia Commonwealth University .
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Richmond,Virginia,23298-0111,United States
Anurag Mehta
Capital Cardiology Associates
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Albany,New York,12211,United States
Parag Shah
Cardiovascular Services .
Recruiting
Peoria,Illinois,61602,United States
Donald Yakel
Texas Cardiology Assocs Of Houston .
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Kingwood,Texas,77339,United States
Fielicia Stowe
Ira H Lieber
California Medical Research Associates Inc
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Northridge,California,91324,United States
Ramachandra Patak
Advanced Medical Research Center
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Saint Petersburg,Florida,33713,United States
Brien Pierpont
Synexus Synexus
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Glendale,Arizona,85306,United States
Elysa Shaw
Rachel Fadden
Graves Gilbert Clinic
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Bowling Green,Kentucky,42101,United States
Jerry Roy
Mountain View Clincal Research Inc .
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Greer,South Carolina,29651,United States
Karleigh Williams
Ronald Mayfield
Fairview Health Services St Johns
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Saint Paul,Minnesota,55103,United States
Les Forgosh
Oliver Chiu
Altru Health Research Dept. .
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Grand Forks,North Dakota,58201,United States
Jason Go
Hackensack University Medical Center Hackensack Univ Medical Center
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Hackensack,New Jersey,07601,United States
Nathaniel Lebowitz
MedCare Pharma LLC Drug Shipment
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Houston,Texas,77079,United States
Afrah Ahmed
Zohair Raza
MGH Clinical Trials
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Boston,Massachusetts,02114 2696,United States
Kaavya Paruchuri
Kim Lannery
Mobile Heart Specialists
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Mobile,Alabama,36608,United States
Christopher S Brown
Care Access
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Warwick,Rhode Island,02886,United States
Sudhir Bansal
Physicians East Endocrinology Research
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Greenville,North Carolina,27834,United States
Mark Warren
Hillcrest Medical Research
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DeLand,Florida,32720,United States
John Hill
Mercury Street Medical
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Butte,Montana,59701,United States
John Pullman
Capital Area Research LLC
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Newport,Pennsylvania,17074,United States
Venkatesh Nadar
Accellacare .
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Knoxville,Tennessee,37912,United States
John Kirby
Novartis Investigative Site
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Hanoi,100000,Vietnam
Novartis Investigative Site
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Ho Chi Minh,700000,Vietnam
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