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.
Study Location
Novartis Investigative Site
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Buenos Aires,W3400abh,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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Caba,Buenos Aires,C1405bch,Argentina
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Rosario,Santa Fe,S200cvd,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 Buenos Aires,C1426,Argentina
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Malvern East,Victoria,3145,Australia
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Joondalup,Western Australia,6027,Australia
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Camperdown,New South Wales,2050,Australia
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Clayton,Victoria,3168,Australia
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Woolloongabba,Queensland,4102,Australia
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Concord,New South Wales,2139,Australia
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Heidelberg,Victoria,3084,Australia
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Sippy Downs,Queensland,4556,Australia
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Hobart,Tasmania,7000,Australia
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Adelaide,South Australia,5000,Australia
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Genk,3600,Belgium
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Mechelen,2800,Belgium
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Hasselt,3500,Belgium
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Aracaju,SE,49055530,Brazil
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Blumenau,Santa Catarina,89020 430,Brazil
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Vitoria,ES,29055-450,Brazil
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Rio de Janeiro,20241-180,Brazil
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Santo Andre,Sao Paulo,09030-010,Brazil
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Campinas,13092-133,Brazil
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Rio de Janeiro,22061-080,Brazil
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Uberlandia,Minas Gerais,38400 500,Brazil
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Porto Alegre,RS,90160093,Brazil
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Sao Jose dos Campos,SP,12243280,Brazil
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Brasilia,DF,70390-903,Brazil
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Campinas,SP,13060 080,Brazil
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Porto Alegre,RS,90560 030,Brazil
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Sao Paulo,SP,01323 000,Brazil
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Brasilia,DF,71625-009,Brazil
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Salvador,BA,40170-130,Brazil
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Belo Horizonte,MG,30140 062,Brazil
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Sao Paulo,SP,04266 010,Brazil
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Curitiba,Parana,80045-170,Brazil
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Sao Paulo,SP,01323001,Brazil
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Brasilia,Distrito Federal,70710-100,Brazil
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Salvador,BA,41820-011,Brazil
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Belo Horizonte,MG,30150-320,Brazil
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Curitiba,PR,80730-150,Brazil
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Sao Paulo,SP,04012-909,Brazil
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Maceio,AL,57051-160,Brazil
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Stara Zagora,6000,Bulgaria
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Pleven,5800,Bulgaria
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Sofia,1202,Bulgaria
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Sandanski,2280,Bulgaria
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Gabrovo,5300,Bulgaria
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Burgas,8000,Bulgaria
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Plovdiv,4002,Bulgaria
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Sofia,1233,Bulgaria
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Sofia,1504,Bulgaria
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Sofia,1510,Bulgaria
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Varna,9010,Bulgaria
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Kyustendil,2500,Bulgaria
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Sofia,1606,Bulgaria
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Veliko Tarnovo,5000,Bulgaria
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Sofia,1709,Bulgaria
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Pernik,2300,Bulgaria
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Blagoevgrad,270 0,Bulgaria
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Floridablanca,Santander,57-7,Colombia
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Medellin,050037,Colombia
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Barranquilla,Atlantico,080002,Colombia
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Manizales,170008,Colombia
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Bogota,110221,Colombia
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Barranquilla,Atlantico,080012,Colombia
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Barranquilla,080020,Colombia
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Medellin,Antioquia,050010,Colombia
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Chia,Cundinamarca,250001,Colombia
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Cali,760004,Colombia
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Medellin,050021,Colombia
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Cali,Valle Del Cauca,760001,Colombia
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Medellin,050012,Colombia
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Bucaramanga,Santander,65265,Colombia
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Ibague,Tolima,730006,Colombia
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San Gil,684031,Colombia
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Rijeka,51000,Croatia
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Karlovac,Karlovacka Zupanija,47000,Croatia
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Opatija,51410,Croatia
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Krapinske toplice,49 217,Croatia
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Osijek,Osijek Baranja,31000,Croatia
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Zagreb,10000,Croatia
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Varazdin,42000,Croatia
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Krapinske Toplice,49217,Croatia
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Pula,52100,Croatia
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Slavonski Brod,35000,Croatia
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Vinkovci,32100,Croatia
Barnum Medical Research Inc .
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Natchitoches,Louisiana,71457,United States
Otis R. Barnum
Cone Health Cancer Center
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Greensboro,North Carolina,27403,United States
Bridgette Christopher
Lillestol Research LLC .
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Fargo,North Dakota,58103,United States
Michael J. Lillestol
Meridian International Research
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Miami Gardens,Florida,33014,United States
Velia Salgado
Renato Carlos Dominguez
Gonzalo Quesada
Cardiovascular Solutions LLC
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Shreveport,Louisiana,71103,United States
Wenwu Zhang
Primed Clinical Research Research
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Dayton,Ohio,45429,United States
William Randall
Eva Collins
Frontier Clinical Research LLC
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Smithfield,Pennsylvania,15478,United States
Marcy Goisse
East West Research Institute
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Honolulu,Hawaii,96814,United States
David Fitz-Patrick
Mountain View Clincal Research Inc .
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Greer,South Carolina,29651,United States
Karleigh Williams
Ronald Mayfield
Advanced Medical Research Center
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Saint Petersburg,Florida,33713,United States
Brien Pierpont
Virginia Commonwealth University .
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Richmond,Virginia,23298-0111,United States
Anurag Mehta
Central Alabama Research
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Birmingham,Alabama,35209,United States
Barry McLean
Synexus Clinical Research
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Columbus,Ohio,43212,United States
Cathy Greiwe
Hudson Valley Urology Cardiovascular Practice
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Poughkeepsie,New York,12601,United States
Camille Finkle
Sunny Suresh Intwala
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
Ascension Saint Agnes Heart Care
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Baltimore,Maryland,21229,United States
Martin Albornoz
West Virginia University Hospital
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Morgantown,West Virginia,26506,United States
Sudarshan Balla
Cognitive Clinical Trials LLC
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Phoenix,Arizona,85044,United States
Kenneth Steil
Texas Cardiology Assocs Of Houston .
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Kingwood,Texas,77339,United States
Ira H Lieber
Fielicia Stowe
Johns Hopkins University
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Columbia,Maryland,21044,United States
Daniel Kim
MedCare Pharma LLC Drug Shipment
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Houston,Texas,77079,United States
Zohair Raza
Afrah Ahmed
Cardiology Associates Medical Group
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Ventura,California,93003,United States
Angelica Medina
Omid Fatemi
Peace River Cardiovascular Center
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Port Charlotte,Florida,33952,United States
David Allan Hotchkiss
Fam Medical Specialists Of Fl Plc
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Plant City,Florida,33563,United States
Theresa Frost
Michael Gimness
Biopharma Informatic LLC .
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Houston,Texas,77084,United States
Humayun Naqvi
CV Ins of the South
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Opelousas,Louisiana,70570,United States
siby george ayalloore
Main Street Physicians Care
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Little River,South Carolina,29566,United States
Stephen D Grubb
Monroe Research Llc Research
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West Monroe,Louisiana,71291,United States
Assad Mouhaffel
Acclaim Clinical Research
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San Diego,California,92120,United States
John Beckes
Uni of California at Los Angeles
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Torrance,California,90502,United States
Matthew Jay Budoff
Carient Heart and Vascular
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Manassas,Virginia,20109,United States
Hamid Taheri
South Oklahoma Heart Research LLC
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Oklahoma City,Oklahoma,73135,United States
Kay Springer
Naeem Tahirkheli
Hightower Clinical Research Central Ok Early Detection Ctr
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Oklahoma City,Oklahoma,73134,United States
Susan Dimick
Epic Medical Research
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Red Oak,Texas,75154,United States
Haresh Boghara
New Jersey Heart
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Linden,New Jersey,07036,United States
Jasjit S Walia
Altru Health Research Dept. .
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Grand Forks,North Dakota,58201,United States
Jason Go
Virginia Heart CLCZ696G2301
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Falls Church,Virginia,22042,United States
Subash Bazaz
Cynthia E Alvarez
Tariq Haddad
Clinical Research Advantage Fiel Family and Sports Med, PC
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Tempe,Arizona,85283,United States
Thomas Fiel
Synexus Clinical Research US Inc
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Tucson,Arizona,85741,United States
Judith Brown
James A Haley Veterans Hospital
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Tampa,Florida,33612,United States
David Whitaker
Capital Area Research LLC
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Newport,Pennsylvania,17074,United States
Venkatesh Nadar
Confluence Health Hospital
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Wenatchee,Washington,98801,United States
Anton Grasch
MGH Clinical Trials
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Boston,Massachusetts,02114 2696,United States
Kaavya Paruchuri
Kim Lannery
Care Access
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Warwick,Rhode Island,02886,United States
Sudhir Bansal
Research Integrity LLC
Recruiting
Owensboro,Kentucky,42303,United States
Kishor Vora
Graves Gilbert Clinic
Recruiting
Bowling Green,Kentucky,42101,United States
Jerry Roy
Alaska Heart and Vascular
Recruiting
Anchorage,Alaska,99508,United States
Jacob Kelly
Cardiovascular Res Found
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Beverly Hills,California,90210,United States
Ronald P Karlsberg
Pharma Tex Research .
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Amarillo,Texas,79106,United States
Ashley Johnson
David Brabham
Flourish Research Research
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Grandwood Park,Illinois,60031,United States
Barbara Hutchinson
Shayna Carter
Northwest Heart Clinical Rsrch LLC .
Recruiting
Arlington Heights,Illinois,60005,United States
Roger Nissen
Atlanta Heart Specialists LLC
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Tucker,Georgia,30084,United States
David Suh
Westchester Medical Center
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Valhalla,New York,10595,United States
Anuritha Tirumani
Hasan Ahmad
Columbia VA Health Care System
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Columbia,South Carolina,29209,United States
Kurt Barringhaus
The Center for Clinical Trials
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Saraland,Alabama,36571,United States
Howard Rubenstein
Janice Orr
Kansas Heart Hospital
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Wichita,Kansas,67226,United States
Thomas Ashcom
Medication Management LLC
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Greensboro,North Carolina,27405,United States
Jagadeesh Ganji
Manassas Clinical Research Center
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Manassas,Virginia,20110,United States
Nabil Andrawis
Adv Imaging Prev and Clin Research Cardio
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Wilmington,North Carolina,28401,United States
Matthew Janik
Rebecca Blackburn
University of Florida Health Science Center Main Centre
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Jacksonville,Florida,32209,United States
Francesco Franchi
Excel Medical Clinical Trials LLC
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Boca Raton,Florida,33434,United States
Seth J Baum
New Phase Research And Development
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Knoxville,Tennessee,37909,United States
Amanda M Miller
Clinical Research Inst of Arizona
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Sun City West,Arizona,85375,United States
Jalal Abbas
Synexus Synexus
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Glendale,Arizona,85306,United States
Elysa Shaw
Rachel Fadden
Javara Research
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Stephenville,Texas,76401,United States
Benjamin Marcum
Lincoln Internal Medicine Associates
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Lincoln,Nebraska,68516,United States
Jason R Potts
AA Medical Research Center
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Flint,Michigan,48504,United States
Ahmed Arif
Trident Cardiology
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Ladson,South Carolina,29465,United States
Frederick Funke
C for Endo Diabetes and MD
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Newhall,California,91321,United States
Sina Tebi
Elite Clinical Research LLC Cardio
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Jackson,Mississippi,39211,United States
Honey East
MultiCare Ins Research Innovation
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Puyallup,Washington,98372,United States
Ahmad Slim
Charles R Drew University of Medicine and Science
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Los Angeles,California,90059,United States
Arnel Joaquin
Synexus Clinical Research US Inc
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Anderson,South Carolina,29621,United States
James Kopp
Hutchinson Clinic
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Hutchinson,Kansas,67502,United States
James Ruhlmann
Kootenai Heart Clinic-Sandpoint
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Sandpoint,Idaho,83864,United States
Emily Kelly
Ronald Jenkins
Cary Research Group .
Recruiting
Cary,North Carolina,27511,United States
Cole Ocker
Sunil Desai
Southern Clinical Research
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Zachary,Louisiana,70791,United States
Ernest Thompson
Hillcrest Medical Research
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DeLand,Florida,32720,United States
John Hill
Blue Coast Research Center LLC .
Recruiting
Vista,California,92081,United States
Hanh Bui
Kareem Wehba
Discovery Clinical Trials .
Recruiting
Pflugerville,Texas,78660-3015,United States
Brian K MacGillivray
Care Access Rapid City
Recruiting
Rapid City,South Dakota,57701,United States
Ali Bajwa
Bhaskar Purushottam
Buffi Green
Capital Cardiology Associates
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Albany,New York,12211,United States
Parag Shah
Amarillo Heart Clin Rsh Inst
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Amarillo,Texas,79124,United States
Joaquin Martinez-Arraras
Hackensack University Medical Center Hackensack Univ Medical Center
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Hackensack,New Jersey,07601,United States
Nathaniel Lebowitz
BayCare Health System .
Recruiting
Tampa,Florida,33705,United States
Van Nguyen
Consano Clinical Research LLC
Recruiting
Shavano Park,Texas,78231,United States
Michelle Welch
Mid Hudson Medical Research PLLC
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New Windsor,New York,12553,United States
Sashi Makam
California Medical Research Associates Inc
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Northridge,California,91324,United States
Ramachandra Patak
Encompass Clinical Research
Recruiting
Spring Valley,California,91978,United States
Hanid Audish
Albany Medical College
Recruiting
Albany,New York,12206,United States
Robert S Busch
Cardiovascular Services .
Recruiting
Peoria,Illinois,61602,United States
Donald Yakel
Physicians East Endocrinology Research
Recruiting
Greenville,North Carolina,27834,United States
Mark Warren
Franciscan Health Services Research Center
Recruiting
Indianapolis,Indiana,46237,United States
Atul Chugh
Northwest Houston Clinical Research PLLC
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Tomball,Texas,77375,United States
Shamaila Aslam
Avant Research Associates LLC
Recruiting
Crowley,Louisiana,70526,United States
Satinder Saini
Comprehensive Center Research
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Weslaco,Texas,78596,United States
Eduardo Luna
Eva Woods
Mercury Street Medical
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Butte,Montana,59701,United States
John Pullman
University of Illinois at Chicago Cardio
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Chicago,Illinois,60612,United States
David Tofovic
Advanced Heart Care, LLC .
Recruiting
Bridgewater,New Jersey,08807,United States
Sharan Mahal
Clinical Research Solution
Recruiting
Houston,Texas,77095,United States
Linda Salinas David
Veena Watwe
Tennessee Center For Clinical Trials
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Tullahoma,Tennessee,37388,United States
Dinesh Gupta
Javara Research .
Recruiting
Fayetteville,Georgia,30214,United States
Charles Kemp
Jessica Kent
NRG Wellness Center Javara Inc
Recruiting
Sugar Land,Texas,77478,United States
Angel Boston
Ronald M Pucillo
Fairview Health Services St Johns
Recruiting
Saint Paul,Minnesota,55103,United States
Les Forgosh
Oliver Chiu
New York Presbyterian Queens .
Recruiting
Flushing,New York,11355,United States
Sijun Kim
Wellmont CVA Heart Institute
Recruiting
Greenville,Tennessee,37745,United States
Jack Whitaker
Accellacare .
Recruiting
Knoxville,Tennessee,37912,United States
John Kirby
Troy Internal Medicine Research .
Recruiting
Troy,Michigan,48098,United States
Heather Papa
Neil J. Fraser
Lynn Health Science Institute
Recruiting
Oklahoma City,Oklahoma,73112,United States
Ryan Morgan
Cleveland Clinic Foundation A 90
Recruiting
Cleveland,Ohio,44195,United States
Leslie Sung Hee Cho
Savica Radesic
Synexus Clinical Research US Inc
Recruiting
Cincinnati,Ohio,45236,United States
Linda Brotherton
Paul Nugent
IMA Medical Research PC Cardiology
Recruiting
Kew Gardens,New York,11415,United States
Pam Toler
Tamas Balogh
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
Lenzmeier Family Practice
Recruiting
Glendale,Arizona,85308,United States
Thomas Lenzmeier
VAMC Research-G V Sonny Montgomery Clinic .
Recruiting
Jackson,Mississippi,39216,United States
Sarah Joiner
CCT Hatboro Medical Associates
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Hatboro,Pennsylvania,19040,United States
Harris Cohen
St Louis Heart and Vascular
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Saint Louis,Missouri,63136,United States
George Kichura
Burke Internal Medicine and Research
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Burke,Virginia,22015,United States
Nashwa Gabra
East Coast Institute for Research .
Recruiting
Jacksonville,Florida,32223,United States
Ashwini Gore
Capitol Cardiology Associates
Recruiting
Lanham,Maryland,20706,United States
Vineet Venugopal
Anderson Medical Research Main Center
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Fort Washington,Maryland,20744,United States
Felton Anderson
Cotton O Neil Clinical Res Center Cotton O Neil Clin Res Ctr
Recruiting
Topeka,Kansas,66606,United States
Michael Cox
Mobile Heart Specialists
Recruiting
Mobile,Alabama,36608,United States
Christopher S Brown
San Diego Cardiac Center
Recruiting
San Diego,California,92123,United States
Jiken Bhatt
Heart House Research Foundation .
Recruiting
Springfield,Ohio,45504,United States
Akber Mohammed
Beacon Health System
Recruiting
Elkhart,Indiana,46514,United States
Julie Large
Troy Weirick
Allegheny General Hospital
Recruiting
Pittsburgh,Pennsylvania,15212,United States
Andrew Oehler
Cambridge Medical Trials .
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Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
Endocrine Associates of Long Island P C
Recruiting
Smithtown,New York,11787,United States
Michael Howard Shanik
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