Phase
Condition
Stroke
Chest Pain
Cardiac Disease
Treatment
REGN7508
Apixaban
REGN9933
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Has AF or flutter (paroxysmal or persistent), not felt to be secondary to areversible cause, and an indication for indefinite anticoagulation treatment asdescribed in the protocol
Meets one of the following:
CHA2DS2-VA [C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years] score ≥2 and OralAnticoagulant (OAC) naïve or
CHA2DS2-VA score ≥3 or
CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in theprotocol
Must have an International Normalization Ratio (INR) <2.5 at the time ofrandomization if taking warfarin or another Vitamin K Antagonist (VKA)
Exclusion
Key Exclusion Criteria:
Has a mechanical heart valve prosthesis (Note: transcatheter aortic valvereplacement is not an exclusion)
Has known moderate-to-severe mitral stenosis
Has had successful ablation therapy or Left Atrial Appendage (LAA)occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described inthe protocol
Had an ischemic stroke within 2 days prior to randomization
Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m^2 within 30 daysprior to randomization or on dialysis or expected to be started as described in theprotocol
Has a history of central nervous system bleeding within 30 days prior torandomization
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Study Design
Connect with a study center
University of Alberta Hospital - Cardiology
Edmonton, Alberta T6G 2G3
CanadaActive - Recruiting
GA Research Associates Ltd.
Moncton, New Brunswick E1G-1A7
CanadaActive - Recruiting
Health sciences North - Cardiology
Greater Sudbury, Ontario P3E 5J1
CanadaActive - Recruiting
Dr James Cha
Oshawa, Ontario L1J 2K1
CanadaActive - Recruiting
Heart Health Institute Research Inc. - Cardiology
Scarborough Village, Ontario M1B 4Z8
CanadaActive - Recruiting
Dr James Cha
Oshawa 6094578, Ontario 6093943 L1J 2K1
CanadaSite Not Available
Heart Health Institute Research Inc. - Cardiology
Scarborough Village 6141900, Ontario 6093943 M1B 4Z8
CanadaSite Not Available
Viacar Recherches Cliniques Inc. - Cardiologie
Longueuil, Quebec J4H 4B9
CanadaActive - Recruiting
Centre Hospitalier Universitaire De Sherbrooke (CHUS) - Cardiologie
Sherbrooke, Quebec J1H 5N4
CanadaActive - Recruiting
Diex Recherche Inc.
Sherbrooke, Quebec J1LOK3
CanadaActive - Recruiting
Diex Recherche Trois-rivieres
Trois-Rivières, Quebec G9A 4P3
CanadaActive - Recruiting
CHU de Quebec-Universite Laval
Québec, G1R 2J6
CanadaActive - Recruiting
SEC Clinical Research
Dothan, Alabama 36305
United StatesActive - Recruiting
Eastern Shore Research Institute
Fairhope, Alabama 36532
United StatesActive - Recruiting
SEC Clinical Research
Dothan 4059102, Alabama 4829764 36305
United StatesSite Not Available
SEC Clinical Research - Cardiology
Dothan 4059102, Alabama 4829764 36305
United StatesActive - Recruiting
Eastern Shore Research Institute
Fairhope 4061234, Alabama 4829764 36532
United StatesSite Not Available
Eastern Shore Research Institute, LLC
Fairhope 4061234, Alabama 4829764 36532
United StatesActive - Recruiting
Mission Cardiovascular Research Institute
Fremont, California 94538
United StatesActive - Recruiting
National Institute of California Heart and Vein Specialists
Huntington Beach, California 92648
United StatesActive - Recruiting
Profound Research LLC at Southern California Heart Specialists
Pasadena, California 91105
United StatesActive - Recruiting
Empire Clinical Research
Pomona, California 91767
United StatesActive - Recruiting
Northbay Clinical Research Center
Santa Rosa, California 95405
United StatesActive - Recruiting
Cardiology Associates Medical Group
Ventura, California 93003
United StatesActive - Recruiting
Interventional Cardiology Medical Group
West Hills, California 91307
United StatesActive - Recruiting
Mission Cardiovascular Research Institute
Fremont 5350734, California 5332921 94538
United StatesSite Not Available
National Institute of California Heart and Vein Specialists
Huntington Beach 5358705, California 5332921 92648
United StatesSite Not Available
National Institute of Clinical Research, Inc. / California Heart Specialists - Cardiology
Huntington Beach 5358705, California 5332921 92648
United StatesActive - Recruiting
Profound Research LLC at Southern California Heart Specialists
Pasadena 5381396, California 5332921 91105
United StatesSite Not Available
Empire Clinical Research
Pomona 5384170, California 5332921 91767
United StatesSite Not Available
Empire Clinical Research - Internal Medicine / Cardiology
Pomona 5384170, California 5332921 91767
United StatesActive - Recruiting
Cardiology Associates Medical Group
Ventura 5405878, California 5332921 93003
United StatesSite Not Available
Interventional Cardiology Medical Group
West Hills 8030162, California 5332921 91307
United StatesSite Not Available
Nouvelle Clinical Research LLC
Cutler Bay, Florida 33189
United StatesActive - Recruiting
Inpatient Research Clinic LLC
Miami Lakes, Florida 33014
United StatesActive - Recruiting
Cardiovascular Center of Sarasota Foundation for Research and Education
Sarasota, Florida 34239
United StatesActive - Recruiting
Clinical Site Partners, LLC DBA Flourish Research
Winter Park, Florida 32789
United StatesActive - Recruiting
Nouvelle Clinical Research LLC
Cutler Bay 6332309, Florida 4155751 33189
United StatesSite Not Available
Nouvelle Clinical Research LLC - Cardiology
Cutler Bay 6332309, Florida 4155751 33189
United StatesActive - Recruiting
Inpatient Research Clinic LLC
Miami Lakes 4164186, Florida 4155751 33014
United StatesSite Not Available
Cardiovascular Center of Sarasota Foundation for Research and Education
Sarasota 4172131, Florida 4155751 34239
United StatesSite Not Available
Clinical Site Partners, LLC DBA Flourish Research
Winter Park 4178560, Florida 4155751 32789
United StatesSite Not Available
Health Sciences Research Building II
Atlanta, Georgia 30322
United StatesActive - Recruiting
NSC Research, Inc
Johns Creek, Georgia 30024
United StatesActive - Recruiting
Health Sciences Research Building II
Atlanta 4180439, Georgia 4197000 30322
United StatesSite Not Available
NSC Research, Inc
Johns Creek 6331909, Georgia 4197000 30024
United StatesSite Not Available
Blue Coast Research Center, LLC
Indianapolis, Indiana 46237
United StatesActive - Recruiting
Franciscan Physician Network, Indiana Heart Physicians
Indianapolis, Indiana 46237
United StatesActive - Recruiting
Indiana University
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Indiana Medical Research
Merrillville, Indiana 46410
United StatesActive - Recruiting
Reid Physician Associates
Richmond, Indiana 47374
United StatesActive - Recruiting
Blue Coast Research Center, LLC
Indianapolis 4259418, Indiana 4921868 46237
United StatesActive - Recruiting
Franciscan Physician Network, Indiana Heart Physicians
Indianapolis 4259418, Indiana 4921868 46237
United StatesSite Not Available
Reid Physician Associates
Richmond 4263681, Indiana 4921868 47374
United StatesSite Not Available
Monroe Research, LLC
West Monroe, Louisiana 71291
United StatesActive - Recruiting
Monroe Research, LLC
West Monroe 4345850, Louisiana 4331987 71291
United StatesSite Not Available
Monroe Research, LLC - Cardiology
West Monroe 4345850, Louisiana 4331987 71291
United StatesActive - Recruiting
Anderson Medical Research
Ft. Washington, Maryland 20744
United StatesActive - Recruiting
Anderson Medical Research
Ft. Washington 4355355, Maryland 4361885 20744
United StatesSite Not Available
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215
United StatesActive - Recruiting
Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)
Boston, Massachusetts 02215
United StatesActive - Recruiting
Profound Research LLC
Farmington Hills, Michigan 48334
United StatesActive - Recruiting
AA Medical Research Center (MRC)
Flint, Michigan 48504
United StatesActive - Recruiting
Profound Research LLC
Farmington Hills 4992523, Michigan 5001836 48334
United StatesSite Not Available
Profound Research LLC at Pulse Cardiology
Farmington Hills 4992523, Michigan 5001836 48334
United StatesActive - Recruiting
AA Medical Research Center (MRC)
Flint 4992982, Michigan 5001836 48504
United StatesSite Not Available
Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research
Greensboro, North Carolina 27401
United StatesActive - Recruiting
K&R Research LLC
Marion, Ohio 43302
United StatesActive - Recruiting
Advanced Medical Research
Maumee, Ohio 43537
United StatesActive - Recruiting
K&R Research LLC
Marion 5161902, Ohio 5165418 43302
United StatesSite Not Available
K&R Research LLC - Internal Medicine
Marion 5161902, Ohio 5165418 43302
United StatesActive - Recruiting
Monument Health Clinical Research
Rapid City, South Dakota 57701
United StatesActive - Recruiting
Monument Health Clinical Research, A Department of Monument Health Rapid City Hospital, Inc
Rapid City 5768233, South Dakota 5769223 57701
United StatesSite Not Available
East Coast Institute for Research, Jefferson City
Jefferson City, Tennessee 37760
United StatesActive - Recruiting
East Coast Institute for Research - Cardiology
Jefferson City 4632959, Tennessee 4662168 37760
United StatesActive - Recruiting
East Coast Institute for Research, Jefferson City
Jefferson City 4632959, Tennessee 4662168 37760
United StatesSite Not Available
PharmaTex Research
Amarillo, Texas 79106
United StatesActive - Recruiting
Complete Heart Care P.A.
McKinney, Texas 75071
United StatesActive - Recruiting
Permian Research Foundation
Odessa, Texas 79761
United StatesActive - Recruiting
Tyler Cardiovascular Consultants
Tyler, Texas 75701
United StatesActive - Recruiting
PharmaTex Research
Amarillo 5516233, Texas 4736286 79106
United StatesSite Not Available
Permian Research Foundation
Odessa 5527554, Texas 4736286 79761
United StatesSite Not Available
Tyler Cardiovascular Consultants
Tyler 4738214, Texas 4736286 75701
United StatesSite Not Available
Alpine Research TC
Clinton, Utah 84015
United StatesActive - Recruiting
Alpine Research TC
Clinton 5773001, Utah 5549030 84015
United StatesSite Not Available
Alpine Research TC - Cardiology
Clinton 5773001, Utah 5549030 84015
United StatesActive - Recruiting

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