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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Monterrey,Nuevo Leon,64610,Mexico
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Chihuahua,31238,Mexico
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Distrito Federal,03100,Mexico
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Mexico,Distrito Federal,14080,Mexico
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Mexico D F,06720,Mexico
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San Luis Potosi,78200,Mexico
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Aguascalientes,20116,Mexico
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Veracruz,91900,Mexico
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Manila,1000,Philippines
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Iloilo,5000,Philippines
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Lisboa,1649 035,Portugal
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Matosinhos,4454 513,Portugal
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Almada,2801 951,Portugal
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Porto,4200 319,Portugal
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Coimbra,3000 075,Portugal
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Santa Maria da Feira,4520 211,Portugal
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Lisboa,1500 650,Portugal
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Setubal,2910-446,Portugal
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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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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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Singapore,169608,Singapore
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Malacky,90122,Slovakia
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Nitra,949 01,Slovakia
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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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Cape Town,7531,South Africa
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Somerset West,Western Cape,7130,South Africa
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Cape Town,Western Cape,7500,South Africa
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Cape Town,ZAF,7570,South Africa
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Marbella,Andalucia,29600,Spain
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Antequera,Malaga,29200,Spain
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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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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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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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Tainan,704,Taiwan
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Tainan,71004,Taiwan
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Taipei,110,Taiwan
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Ubon Ratchathani,34000,Thailand
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Songkhla,Hat Yai,90110,Thailand
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Bangkok,10700,Thailand
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Khon Kaen,THA,40002,Thailand
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Chiang Mai,50200,Thailand
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Bangkok,10330,Thailand
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Muang,12120,Thailand
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Bangkok,10400,Thailand
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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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Izmir,35100,Turkey
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Izmir,35340,Turkey
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Wirrel,Ch62 6ee,United Kingdom
Lenzmeier Family Practice
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Glendale,Arizona,85308,United States
Thomas Lenzmeier
Peace River Cardiovascular Center
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Port Charlotte,Florida,33952,United States
David Allan Hotchkiss
Johns Hopkins University
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Columbia,Maryland,21044,United States
Daniel Kim
Care Access
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Warwick,Rhode Island,02886,United States
Sudhir Bansal
Northwest Houston Clinical Research PLLC
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Tomball,Texas,77375,United States
Shamaila Aslam
Blue Coast Research Center LLC .
Recruiting
Vista,California,92081,United States
Kareem Wehba
Hanh Bui
Cotton O Neil Clinical Res Center Cotton O Neil Clin Res Ctr
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Topeka,Kansas,66606,United States
Michael Cox
New York Presbyterian Queens .
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Flushing,New York,11355,United States
Sijun Kim
Amarillo Heart Clin Rsh Inst
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Amarillo,Texas,79124,United States
Joaquin Martinez-Arraras
East West Research Institute
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Honolulu,Hawaii,96814,United States
David Fitz-Patrick
VAMC Research-G V Sonny Montgomery Clinic .
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Jackson,Mississippi,39216,United States
Sarah Joiner
Monument Health Clinical Research A Depart Of Monument Health
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Rapid City,South Dakota,57701,United States
Bhaskar Purushottam
Buffi Green
Ali Bajwa
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
CV Ins of the South
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Opelousas,Louisiana,70570,United States
siby george ayalloore
Cone Health Cancer Center
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Greensboro,North Carolina,27403,United States
Bridgette Christopher
Synexus Clinical Research
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Columbus,Ohio,43212,United States
Cathy Greiwe
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
Accellacare .
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Knoxville,Tennessee,37912,United States
John Kirby
The Center for Clinical Trials
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Saraland,Alabama,36571,United States
Howard Rubenstein
Janice Orr
Capital Area Research LLC
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Newport,Pennsylvania,17074,United States
Venkatesh Nadar
Consano Clinical Research LLC
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Shavano Park,Texas,78231,United States
Michelle Welch
Uni of California at Los Angeles
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Torrance,California,90502,United States
Matthew Jay Budoff
Franciscan Health Services Research Center
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Indianapolis,Indiana,46237,United States
Atul Chugh
New Jersey Heart
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Linden,New Jersey,07036,United States
Jasjit S Walia
Clinical Research Advantage Fiel Family and Sports Med, PC
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Tempe,Arizona,85283,United States
Thomas Fiel
BayCare Health System .
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Tampa,Florida,33705,United States
Van Nguyen
AA Medical Research Center
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Flint,Michigan,48504,United States
Ahmed Arif
Mountain View Clincal Research Inc .
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Greer,South Carolina,29651,United States
Ronald Mayfield
Karleigh Williams
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
Cambridge Medical Trials .
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Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
Endocrine Associates of Long Island P C
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Smithtown,New York,11787,United States
Michael Howard Shanik
Flourish Research Research
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Grandwood Park,Illinois,60031,United States
Shayna Carter
Barbara Hutchinson
Lincoln Internal Medicine Associates
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Lincoln,Nebraska,68516,United States
Jason R Potts
Wellmont CVA Heart Institute
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Greenville,Tennessee,37745,United States
Jack Whitaker
MultiCare Ins Research Innovation
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Puyallup,Washington,98372,United States
Ahmad Slim
Ascension Saint Agnes Heart Care
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Baltimore,Maryland,21229,United States
Martin Albornoz
Adv Imaging Prev and Clin Research Cardio
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Wilmington,North Carolina,28401,United States
Rebecca Blackburn
Matthew Janik
Hightower Clinical Research Central Ok Early Detection Ctr
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Oklahoma City,Oklahoma,73134,United States
Susan Dimick
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
Anderson Medical Research Main Center
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Fort Washington,Maryland,20744,United States
Felton Anderson
Comprehensive Center Research
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Weslaco,Texas,78596,United States
Eduardo Luna
Eva Woods
Excel Medical Clinical Trials LLC
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Boca Raton,Florida,33434,United States
Seth J Baum
Kansas Heart Hospital
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Wichita,Kansas,67226,United States
Thomas Ashcom
IMA Medical Research PC Cardiology
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Kew Gardens,New York,11415,United States
Pam Toler
Tamas Balogh
Charles R Drew University of Medicine and Science
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Los Angeles,California,90059,United States
Arnel Joaquin
Kootenai Heart Clinic-Sandpoint
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Sandpoint,Idaho,83864,United States
Emily Kelly
Ronald Jenkins
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
Eva Collins
William Randall
Buynak Clinical Research PC
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Valparaiso,Indiana,46383,United States
Robert Buynak
Albany Medical College
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Albany,New York,12206,United States
Robert S Busch
Javara Research
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Stephenville,Texas,76401,United States
Benjamin Marcum
Synexus Clinical Research US Inc
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Tucson,Arizona,85741,United States
Judith Brown
Javara Research .
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Fayetteville,Georgia,30214,United States
Charles Kemp
Jessica Kent
Troy Internal Medicine Research .
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Troy,Michigan,48098,United States
Heather Papa
Neil J. Fraser
Trident Cardiology
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Ladson,South Carolina,29465,United States
Frederick Funke
Avant Research Associates LLC
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Crowley,Louisiana,70526,United States
Satinder Saini
Synexus Clinical Research US Inc
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Cincinnati,Ohio,45236,United States
Linda Brotherton
Paul Nugent
San Diego Cardiac Center
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San Diego,California,92123,United States
Jiken Bhatt
Cardiovascular Services .
Recruiting
Peoria,Illinois,61602,United States
Donald Yakel
Advanced Heart Care, LLC .
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Bridgewater,New Jersey,08807,United States
Sharan Mahal
Confluence Health Hospital
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Wenatchee,Washington,98801,United States
Anton Grasch
Lillestol Research LLC .
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Fargo,North Dakota,58103,United States
Michael J. Lillestol
Epic Medical Research
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Red Oak,Texas,75154,United States
Haresh Boghara
Graves Gilbert Clinic
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Bowling Green,Kentucky,42101,United States
Jerry Roy
Cognitive Clinical Trials LLC
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Phoenix,Arizona,85044,United States
Kenneth Steil
Advanced Medical Research Center
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Saint Petersburg,Florida,33713,United States
Brien Pierpont
Capitol Cardiology Associates
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Lanham,Maryland,20706,United States
Vineet Venugopal
Synexus Clinical Research US Inc
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Anderson,South Carolina,29621,United States
James Kopp
St Louis Heart and Vascular
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Saint Louis,Missouri,63136,United States
George Kichura
Manassas Clinical Research Center
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Manassas,Virginia,20110,United States
Nabil Andrawis
Medication Management LLC
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Greensboro,North Carolina,27405,United States
Jagadeesh Ganji
Clinical Research Solution
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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
Alaska Heart and Vascular
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Anchorage,Alaska,99508,United States
Jacob Kelly
Allegheny General Hospital
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Pittsburgh,Pennsylvania,15212,United States
Andrew Oehler
Westchester Medical Center
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Valhalla,New York,10595,United States
Anuritha Tirumani
Hasan Ahmad
East Coast Institute for Research .
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Jacksonville,Florida,32223,United States
Ashwini Gore
Central Alabama Research
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Birmingham,Alabama,35209,United States
Barry McLean
South Oklahoma Heart Research LLC
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Oklahoma City,Oklahoma,73135,United States
Kay Springer
Naeem Tahirkheli
Mid Hudson Medical Research PLLC
Recruiting
New Windsor,New York,12553,United States
Sashi Makam
Burke Internal Medicine and Research
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Burke,Virginia,22015,United States
Nashwa Gabra
Monroe Research Llc Research
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West Monroe,Louisiana,71291,United States
Assad Mouhaffel
Heart House Research Foundation .
Recruiting
Springfield,Ohio,45504,United States
Akber Mohammed
C for Endo Diabetes and MD
Recruiting
Newhall,California,91321,United States
Sina Tebi
Northwest Heart Clinical Rsrch LLC .
Recruiting
Arlington Heights,Illinois,60005,United States
Roger Nissen
Cardiology Associates Medical Group
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Ventura,California,93003,United States
Angelica Medina
Omid Fatemi
Hutchinson Clinic
Recruiting
Hutchinson,Kansas,67502,United States
James Ruhlmann
Capital Cardiology Associates
Recruiting
Albany,New York,12211,United States
Parag Shah
NRG Wellness Center Javara Inc
Recruiting
Sugar Land,Texas,77478,United States
Angel Boston
Ronald M Pucillo
Barnum Medical Research Inc .
Recruiting
Natchitoches,Louisiana,71457,United States
Otis R. Barnum
Cleveland Clinic Foundation A 90
Recruiting
Cleveland,Ohio,44195,United States
Leslie Sung Hee Cho
Savica Radesic
Cardiovascular Res Found
Recruiting
Beverly Hills,California,90210,United States
Ronald P Karlsberg
Atlanta Heart Specialists LLC
Recruiting
Tucker,Georgia,30084,United States
David Suh
Fairview Health Services St Johns
Recruiting
Saint Paul,Minnesota,55103,United States
Les Forgosh
Oliver Chiu
Main Street Physicians Care
Recruiting
Little River,South Carolina,29566,United States
Stephen D Grubb
Altru Health Research Dept. .
Recruiting
Grand Forks,North Dakota,58201,United States
Jason Go
Northeast Clinical Research of San Antonio LLC
Recruiting
San Antonio,Texas,78233,United States
Arthur Guerrero
Encompass Clinical Research
Recruiting
Spring Valley,California,91978,United States
Hanid Audish
Beacon Health System
Recruiting
Elkhart,Indiana,46514,United States
Julie Large
Troy Weirick
Hackensack University Medical Center Hackensack Univ Medical Center
Recruiting
Hackensack,New Jersey,07601,United States
Nathaniel Lebowitz
West Virginia University Hospital
Recruiting
Morgantown,West Virginia,26506,United States
Sudarshan Balla
Research Integrity LLC
Recruiting
Owensboro,Kentucky,42303,United States
Kishor Vora
Clinical Research Inst of Arizona
Recruiting
Sun City West,Arizona,85375,United States
Jalal Abbas
James A Haley Veterans Hospital
Recruiting
Tampa,Florida,33612,United States
David Whitaker
MGH Clinical Trials
Recruiting
Boston,Massachusetts,02114 2696,United States
Kaavya Paruchuri
Kim Lannery
Columbia VA Health Care System
Recruiting
Columbia,South Carolina,29209,United States
Kurt Barringhaus
Physicians East Endocrinology Research
Recruiting
Greenville,North Carolina,27834,United States
Mark Warren
Texas Cardiology Assocs Of Houston .
Recruiting
Kingwood,Texas,77339,United States
Fielicia Stowe
Ira H Lieber
California Medical Research Associates Inc
Recruiting
Northridge,California,91324,United States
Ramachandra Patak
Mercury Street Medical
Recruiting
Butte,Montana,59701,United States
John Pullman
Virginia Commonwealth University .
Recruiting
Richmond,Virginia,23298-0111,United States
Anurag Mehta
Frontier Clinical Research LLC
Recruiting
Smithfield,Pennsylvania,15478,United States
Marcy Goisse
Pharma Tex Research .
Recruiting
Amarillo,Texas,79106,United States
Ashley Johnson
David Brabham
Synexus Synexus
Recruiting
Glendale,Arizona,85306,United States
Elysa Shaw
Rachel Fadden
Fam Medical Specialists Of Fl Plc
Recruiting
Plant City,Florida,33563,United States
Michael Gimness
Theresa Frost
Cary Research Group .
Recruiting
Cary,North Carolina,27511,United States
Cole Ocker
Sunil Desai
MedCare Pharma LLC Drug Shipment
Recruiting
Houston,Texas,77079,United States
Afrah Ahmed
Zohair Raza
CCT Hatboro Medical Associates
Recruiting
Hatboro,Pennsylvania,19040,United States
Harris Cohen
New Phase Research And Development
Recruiting
Knoxville,Tennessee,37909,United States
Amanda M Miller
Mobile Heart Specialists
Recruiting
Mobile,Alabama,36608,United States
Christopher S Brown
Hillcrest Medical Research
Recruiting
DeLand,Florida,32720,United States
John Hill
Hudson Valley Urology Cardiovascular Practice
Recruiting
Poughkeepsie,New York,12601,United States
Camille Finkle
Sunny Suresh Intwala
Southern Clinical Research
Recruiting
Zachary,Louisiana,70791,United States
Ernest Thompson
Lynn Health Science Institute
Recruiting
Oklahoma City,Oklahoma,73112,United States
Ryan Morgan
University of Illinois at Chicago Cardio
Recruiting
Chicago,Illinois,60612,United States
David Tofovic
Elite Clinical Research LLC Cardio
Recruiting
Jackson,Mississippi,39211,United States
Honey East
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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