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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Kansas Heart Hospital
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Wichita,Kansas,67226,United States
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Virginia Heart CLCZ696G2301
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Falls Church,Virginia,22042,United States
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Cynthia E Alvarez
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Chase Medical Research LLC Research
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Waterbury,Connecticut,06708,United States
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Amarillo Heart Clin Rsh Inst
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Amarillo,Texas,79124,United States
Joaquin Martinez-Arraras
Central Alabama Research
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Birmingham,Alabama,35209,United States
Barry McLean
Cleveland Clinic Foundation A 90
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Cleveland,Ohio,44195,United States
Leslie Sung Hee Cho
Savica Radesic
Lincoln Internal Medicine Associates
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Lincoln,Nebraska,68516,United States
Jason R Potts
Confluence Health Hospital
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Wenatchee,Washington,98801,United States
Anton Grasch
Cardiovascular Solutions LLC
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Shreveport,Louisiana,71103,United States
Wenwu Zhang
Clinical Research Solution Cypress
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Houston,Texas,77095,United States
Veena Watwe
Fadi Alameddine
Feras Mohamed
Linda Salinas David
James A Haley Veterans Hospital
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Tampa,Florida,33612,United States
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Columbia VA Health Care System
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Columbia,South Carolina,29209,United States
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Mid Hudson Medical Research PLLC
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New Windsor,New York,12553,United States
Sashi Makam
C for Endo Diabetes and MD
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Newhall,California,91321,United States
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Flourish Research Research Department
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Bowie,Maryland,20715,United States
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Avant Research Associates LLC
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Crowley,Louisiana,70526,United States
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RM Medical Research Inc
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Miami Lakes,Florida,33014,United States
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Velia Salgado
Renato Carlos Dominguez
Lenzmeier Family Practice
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Glendale,Arizona,85308,United States
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Lynn Health Science Institute
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Oklahoma City,Oklahoma,73112,United States
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Clinical Research of South Nevada .
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Las Vegas,Nevada,89121,United States
Roger Estevez
Epic Medical Research
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Red Oak,Texas,75154,United States
Haresh Boghara
Northwest Heart Clinical Rsrch LLC .
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Arlington Heights,Illinois,60005,United States
Roger Nissen
Care Access Rapid City
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Rapid City,South Dakota,57701,United States
Ali Bajwa
Bhaskar Purushottam
Buffi Green
Medication Management LLC
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Greensboro,North Carolina,27408,United States
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Acclaim Clinical Research
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San Diego,California,92120,United States
John Beckes
Troy Internal Medicine Research .
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Troy,Michigan,48098,United States
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Neil J. Fraser
Capital Cardiology Associates
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Albany,New York,12211,United States
Parag Shah
Hope Clinical Research
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Canoga Park,California,91303,United States
Hessam Aazami
West Broadway Clinic Cardio
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Council Bluffs,Iowa,51501,United States
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Samantha Opal
Comprehensive Center Research
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Weslaco,Texas,78596,United States
Eva Woods
Eduardo Luna
Blue Coast Research Center LLC .
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Vista,California,92081,United States
Kareem Wehba
Hanh Bui
Cardiovascular Res of Knoxville LLC
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Powell,Tennessee,37849,United States
Charles B Treasure
Altru Health Research Dept. .
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Grand Forks,North Dakota,58201,United States
Jason Go
St Louis Heart and Vascular
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Saint Louis,Missouri,63136,United States
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Centricity Research Suffolk PCare Research
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Suffolk,Virginia,23434,United States
Samir Abdelshaheed
NOLA Care Clinical Research
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Metairie,Louisiana,70006,United States
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Tina Messina
Harold Miller
MedCare Pharma LLC Drug Shipment
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Houston,Texas,77079,United States
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Afrah Ahmed
Fam Medical Specialists Of Fl Plc
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Plant City,Florida,33563,United States
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Theresa Frost
Frontier Clinical Research LLC
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Smithfield,Pennsylvania,15478,United States
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Research Integrity LLC
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Owensboro,Kentucky,42303,United States
Kishor Vora
Zenith Clinical Research
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Hollywood,Florida,33021,United States
Moises Issa
VA North Texas Health Care System .
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Dallas,Texas,75216,United States
Kyaw Soe
The Center for Clinical Trials
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Saraland,Alabama,36571,United States
Janice Orr
Howard Rubenstein
Methodist Physicians Clinic Cardiology
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Omaha,Nebraska,68114,United States
Thomas Wolf
Ascension Saint Agnes Heart Care
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Baltimore,Maryland,21229,United States
Martin Albornoz
Epic Clinical Research
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Lewisville,Texas,75057,United States
Manjoo Sharma
Atlanta Heart Specialists LLC
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Tucker,Georgia,30084,United States
David Suh
Trident Cardiology
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Ladson,South Carolina,29465,United States
Frederick Funke
Cary Research Group .
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Cary,North Carolina,27511,United States
Cole Ocker
Sunil Desai
Clinical Trials Research Sacramento
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Sacramento,California,95821-2134,United States
Jeffrey D Wayne
Continental Clinical
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Towson,Maryland,21204,United States
Gregory Pokrywka
East Texas Cardiology PA .
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Houston,Texas,77002,United States
Anwar Ahmad
Eminat LLC
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Miramar,Florida,33027,United States
Yaneth Trujillo
Hatboro Medical Associates P C
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Hatboro,Pennsylvania,19040,United States
Harris Cohen
Synexus Clinical Research US Inc
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Tucson,Arizona,85741,United States
Judith Brown
New Jersey Heart
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Linden,New Jersey,07036,United States
Jasjit S Walia
Beacon Health System
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Elkhart,Indiana,46514,United States
Julie Large
Troy Weirick
Javara Research
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Stephenville,Texas,76401,United States
Benjamin Marcum
Adv Imaging Prev and Clin Research Cardio
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Wilmington,North Carolina,28401,United States
Matthew Janik
Rebecca Blackburn
Uni of California at Los Angeles
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Torrance,California,90502,United States
Matthew Jay Budoff
Park Nicollet Institute Park Nicollet Medical Ctr
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Saint Louis Park,Minnesota,55416,United States
Pawan Hari
Manassas Clinical Research Center
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Manassas,Virginia,20110,United States
Nabil Andrawis
Hudson Valley Urology Cardiovascular Practice
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Poughkeepsie,New York,12601,United States
Camille Finkle
Sunny Suresh Intwala
California Medical Research Associates Inc
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Northridge,California,91324,United States
Ramachandra Patak
Graves Gilbert Clinic
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Bowling Green,Kentucky,42101,United States
Jerry Roy
Excel Medical Clinical Trials LLC
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Boca Raton,Florida,33434,United States
Seth J Baum
Louisiana Heart Center Research .
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Slidell,Louisiana,70458,United States
Marc Bernstein
Doctors Hospital at Renaissance
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Edinburg,Texas,78539,United States
Mahesh G. Changlani
Cognitive Clinical Trials LLC
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Phoenix,Arizona,85044,United States
Kenneth Steil
Hightower Clinical Research Central Ok Early Detection Ctr
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Oklahoma City,Oklahoma,73134,United States
Susan Dimick
Advanced Heart Care, LLC .
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Bridgewater,New Jersey,08807,United States
Sharan Mahal
Chicago Clinical Research Inst
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Chicago,Illinois,60607,United States
Dennis Levinson
Physicians East Endocrinology Research
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Greenville,North Carolina,27834,United States
Mark Warren
San Diego Cardiac Center
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San Diego,California,92123,United States
Jiken Bhatt
Biopharma Informatic LLC .
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Houston,Texas,77084,United States
Humayun Naqvi
New York Presbyterian Queens .
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Flushing,New York,11355,United States
Sijun Kim
Burke Internal Medi And Research
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Burke,Virginia,22015,United States
Nashwa Gabra
Interv Cardiology Med Grp
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West Hills,California,91307,United States
Farhad Rafii
Barnum Medical Research Inc .
Recruiting
Natchitoches,Louisiana,71457,United States
Otis R. Barnum
Zenos Clinical Research
Recruiting
Dallas,Texas,75230,United States
James Lilly
Alaska Heart and Vascular
Recruiting
Anchorage,Alaska,99508,United States
Jacob Kelly
Rama Research LLC
Recruiting
Marion,Ohio,43302,United States
Bhola Rama
Las Vegas Endocrinology
Recruiting
Henderson,Nevada,89074,United States
Quang Nguyen
East West Research Institute
Recruiting
Honolulu,Hawaii,96814,United States
David Fitz-Patrick
Main Street Physicians Care
Recruiting
Little River,South Carolina,29566,United States
Stephen D Grubb
Primecare Medical Group
Recruiting
Houston,Texas,77024,United States
Ankur Doshi
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
BayCare Health System .
Recruiting
Tampa,Florida,33705,United States
Van Nguyen
Bon Secours Medical Group
Recruiting
Greenville,South Carolina,29607,United States
James Merriam
Johns Hopkins University
Recruiting
Columbia,Maryland,21044,United States
Daniel Kim
North Hills Medical Research Inc .
Recruiting
Bedford,Texas,76021,United States
John D Gabriel
Longwood Research
Recruiting
Huntsville,Alabama,35801,United States
Saadat Ansari
Synexus Clinical Research
Recruiting
Columbus,Ohio,43212,United States
Cathy Greiwe
Nebraska Heart Inst Med Office Bldg
Recruiting
Lincoln,Nebraska,68526,United States
Anand Deshmukh
West Virginia University Hospital
Recruiting
Morgantown,West Virginia,26506,United States
Jacob Krafcheck
Sudarshan Balla
Essentia Health Duluth Clinic
Recruiting
Duluth,Minnesota,55805,United States
Catherine Benziger
Louisiana Heart Center Research .
Recruiting
Hammond,Louisiana,70403,United States
Bruce J Iteld
David Turbay MD PLLC
Recruiting
El Paso,Texas,79905,United States
David Turbay
Consano Clinical Research LLC
Recruiting
Shavano Park,Texas,78231,United States
Michelle Welch
MultiCare Ins Research Innovation
Recruiting
Puyallup,Washington,98372,United States
Ahmad Slim
Peace River Cardiovascular Center
Recruiting
Port Charlotte,Florida,33952,United States
David Allan Hotchkiss
Care Access
Recruiting
Warwick,Rhode Island,02886,United States
Sudhir Bansal
Keck Medical Center USC Keck School of Medicine of USC
Recruiting
Los Angeles,California,90033,United States
Parveen Garg
Hutchinson Clinic
Recruiting
Hutchinson,Kansas,67502,United States
James Ruhlmann
Tennessee Center For Clinical Trials
Recruiting
Tullahoma,Tennessee,37388,United States
Dinesh Gupta
Aultman Hospital Main Centre
Recruiting
Canton,Ohio,44710,United States
Prabhakaran Gopalakrishnan
Mercury Street Medical
Recruiting
Butte,Montana,59701,United States
John Pullman
East Texas Research Associates Inc.
Recruiting
Livingston,Texas,77351,United States
Kuruvilla Mani Cheriparambil
South Charlotte Cardiology P C
Recruiting
Charlotte,North Carolina,28277,United States
James Liu
Cordova Clinical Research
Recruiting
Sacramento,California,95841,United States
Muhammad Yusufzai
MGH Clinical Trials
Recruiting
Boston,Massachusetts,02114 2696,United States
Kaavya Paruchuri
Sara Haidermota
Cambridge Medical Trials .
Recruiting
Alexandria,Louisiana,71301,United States
Naseem A Jaffrani
University of Florida Health Science Center Main Centre
Recruiting
Jacksonville,Florida,32209,United States
Francesco Franchi
Metropolitan Cardiovascular Consultants Llc
Recruiting
Beltsville,Maryland,20705,United States
Ayim Akyea-Djamson
Wake Forest U of Health Sciences
Recruiting
Winston-Salem,North Carolina,27157,United States
Michael Shapiro
Sonya Price
Virginia Commonwealth University .
Recruiting
Richmond,Virginia,23298-0111,United States
Anurag Mehta
Advent Health Orlando Research
Recruiting
Orlando,Florida,32803,United States
Rohit Bhatheja
Capital Area Research LLC
Recruiting
Newport,Pennsylvania,17074,United States
Venkatesh Nadar
Cardiovascular Res Found
Recruiting
Beverly Hills,California,90210,United States
Ronald P Karlsberg
Albany Medical College
Recruiting
Albany,New York,12206,United States
Robert S Busch
Franciscan Health Services Research Center
Recruiting
Indianapolis,Indiana,46237,United States
Atul Chugh
New Phase Research And Development
Recruiting
Knoxville,Tennessee,37909,United States
Amanda M Miller
Monroe Research Llc Research
Recruiting
West Monroe,Louisiana,71291,United States
Assad Mouhaffel
Endocrine Associates of Long Island P C
Recruiting
Smithtown,New York,11787,United States
Michael Howard Shanik
Valley Clinical Trials .
Recruiting
Northridge,California,91325,United States
Mehrdad Ariani
The Research Group .
Recruiting
Lexington,Kentucky,40503,United States
Justin Arambasick
University of Illinois at Chicago Cardio
Recruiting
Chicago,Illinois,60612,United States
David Tofovic
IMA Research Clinical Research
Recruiting
Mount Airy,North Carolina,27030,United States
Johnny R Dy
Encompass Clinical Research
Recruiting
Spring Valley,California,91978,United States
Hanid Audish
Heart Care Associates P C
Recruiting
Hopewell,Virginia,23860,United States
Kamlesh Dave
Clinical Research Inst of Arizona
Recruiting
Sun City West,Arizona,85375,United States
Jalal Abbas
South Oklahoma Heart Research LLC
Recruiting
Oklahoma City,Oklahoma,73135,United States
Kay Springer
Naeem Tahirkheli
Cardiovas Assoc of Delaware Valley
Recruiting
Elmer,New Jersey,08318,United States
Dilip Viswanath
CV Ins of the South
Recruiting
Opelousas,Louisiana,70570,United States
siby george ayalloore
IMA Medical Research PC Cardiology
Recruiting
Kew Gardens,New York,11415,United States
Pam Toler
Tamas Balogh
South Denver Cardiology Associates PC
Recruiting
Littleton,Colorado,80120,United States
Paul Jurgens
Kootenai Heart Clinic-Sandpoint
Recruiting
Sandpoint,Idaho,83864,United States
Emily Kelly
Ronald Jenkins
Cone Health Cancer Center
Recruiting
Greensboro,North Carolina,27403,United States
Bridgette Christopher
University of California San Diego .
Recruiting
San Diego,California,92103,United States
Michael John Wilkinson
SW Family Medicine Associates
Recruiting
Dallas,Texas,75235,United States
Chrisette Dharma
Synexus Synexus
Recruiting
Glendale,Arizona,85306,United States
Elysa Shaw
Rachel Fadden
Heart House Research Foundation .
Recruiting
Springfield,Ohio,45504,United States
Akber Mohammed
AB Clinical Trials .
Recruiting
Las Vegas,Nevada,89119,United States
Atoya Adams
Karen Sullivan
Elite Clinical Research LLC Cardio
Recruiting
Jackson,Mississippi,39211,United States
Honey East
Northwest Houston Cardiology PA
Recruiting
Houston,Texas,77070,United States
Krishnamoorthy Vivekananthan
Northwest Houston Clinical Research
Recruiting
Tomball,Texas,77375,United States
Shamaila Aslam
VA Medical Center - NWI, Endocrine Studies (R151)
Recruiting
Omaha,Nebraska,68105,United States
Cyrus De Souza
Midwest Endocrinology Associates Research
Recruiting
Milwaukee,Wisconsin,53215,United States
Oscar Sanchez
Javara Research .
Recruiting
Fayetteville,Georgia,30214,United States
Charles Kemp
Jessica Kent
Mountain View Clincal Research Inc .
Recruiting
Greer,South Carolina,29651,United States
Karleigh Williams
Ronald Mayfield
Anderson Medical Research Main Center
Recruiting
Fort Washington,Maryland,20744,United States
Felton Anderson
Novel Research LLC Research
Recruiting
Bellaire,Texas,77401,United States
Hassan Khan
Michele Sartori
Mobile Heart Specialists
Recruiting
Mobile,Alabama,36608,United States
Christopher S Brown
Primed Clinical Research Research
Recruiting
Dayton,Ohio,45429,United States
Eva Collins
William Randall
Ctr For Clin Rsrch And Innovation Cardio
Recruiting
Spring,Texas,77389,United States
Amie Sun-Wright
Ashly Abraham
Abbott Northwestern Hospital
Recruiting
Minneapolis,Minnesota,55407-3799,United States
Jonathan Urbach
Sophia Clark
Bethesda Medical Clinic
Recruiting
Marrero,Louisiana,70072,United States
Mary Jane Lalla
Shibu Varughese
Texas Health Physicians Group
Recruiting
Fort Worth,Texas,76107,United States
R Todd Richwine
Springs Medical And Research
Recruiting
Miami,Florida,33135,United States
Merlin Osorio
Pharma Tex Research .
Recruiting
Amarillo,Texas,79106,United States
Ashley Johnson
David Brabham
Synexus Clinical Research US Inc
Recruiting
Cincinnati,Ohio,45236,United States
Linda Brotherton
Paul Nugent
Nebraska Heart Institute CHI Health Nebraska
Recruiting
Lincoln,Nebraska,68510,United States
Douglas Kosmicki
Universal Research Group LLC .
Recruiting
Tacoma,Washington,98405,United States
Sabrina Benjamin
Advanced Medical Research Center
Recruiting
Saint Petersburg,Florida,33713,United States
Brien Pierpont
Synexus Clinical Research US Inc
Recruiting
Anderson,South Carolina,29621,United States
James Kopp
Charles R Drew Uni Of Med And Sci
Recruiting
Los Angeles,California,90059,United States
Arnel Joaquin
Cotton O Neil Clinical Research Institute
Recruiting
Topeka,Kansas,66606,United States
Michael Cox
Discovery Clinical Trials .
Recruiting
Pflugerville,Texas,78660-3015,United States
Brian K MacGillivray
AA Medical Research Center
Recruiting
Flint,Michigan,48504,United States
Ahmed Arif
Cardiovascular Associates Research Main Center
Recruiting
Covington,Louisiana,70433,United States
Dale Presser
East Coast Institute for Research .
Recruiting
Jacksonville,Florida,32223,United States
Ashwini Gore
Buynak Clinical Research PC
Recruiting
Valparaiso,Indiana,46383,United States
Robert Buynak
Cardiology Associates Medical Group
Recruiting
Ventura,California,93003,United States
Omid Fatemi
Angelica Medina
Accellacare .
Recruiting
Knoxville,Tennessee,37912,United States
John Kirby
Lillestol Research LLC .
Recruiting
Fargo,North Dakota,58103,United States
Michael J. Lillestol
Kansas City VA Medical Center
Recruiting
Kansas City,Missouri,64128,United States
Vikas Singh
CTMD Research
Recruiting
Palm Springs,Florida,33406,United States
Luis Castillo
Allegheny General Hospital
Recruiting
Pittsburgh,Pennsylvania,15212,United States
Andrew Oehler
National Heart Institute
Recruiting
Beverly Hills,California,90211,United States
Norman Lepor
Cardiovascular Research and Education Foundation Inc
Recruiting
Wausau,Wisconsin,54401,United States
Daniel Krause
Southern Clinical Research
Recruiting
Zachary,Louisiana,70791,United States
Ernest Thompson
Texas Cardiology Assocs Of Houston .
Recruiting
Kingwood,Texas,77339,United States
Fielicia Stowe
Ira H Lieber
Westchester Medical Center
Recruiting
Valhalla,New York,10595,United States
Anuritha Tirumani
Hasan Ahmad
VA Palo Alto Health Care System
Recruiting
Palo Alto,California,94304-1207,United States
Shriram Nallamshetty
Capitol Cardiology Associates
Recruiting
Lanham,Maryland,20706,United States
Vineet Venugopal
Norton Healthcare Inc .
Recruiting
Louisville,Kentucky,40202,United States
Mostafa El-Refai
Hillcrest Medical Research
Recruiting
DeLand,Florida,32720,United States
John Hill
Hackensack Univ Med Ctr
Recruiting
Hackensack,New Jersey,07601,United States
Nathaniel Lebowitz
Cardiovascular Services .
Recruiting
Peoria,Illinois,61602,United States
Donald Yakel
Wellmont CVA Heart Institute
Recruiting
Greenville,Tennessee,37745,United States
Jack Whitaker
Accellacare .
Recruiting
Statesville,North Carolina,28625,United States
Bruce Seaton
Stanford University Medical Center Center For Clinical Research
Recruiting
Stanford,California,94305,United States
Joshua Knowles
Carient Heart and Vascular
Recruiting
Manassas,Virginia,20109,United States
Hamid Taheri
A&A Research Group Inc
Recruiting
Miami,Florida,33186,United States
Aniel Navarro Marin
Clinical Research Advantage Fiel Family and Sports Med, PC
Recruiting
Tempe,Arizona,85283,United States
Thomas Fiel
Cardiology Of Tulsa Inc Saint Francis Hospital
Recruiting
Tulsa,Oklahoma,74136,United States
Andrew Kurklinsky
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