Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Phase 2 – studying effectiveness and dosage
Conditions:
Atrial Fibrillation (AF)
Sponsor: Regeneron Pharmaceuticals
trial.available_in:
БГ
Overview
This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation.
The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.
The study is looking at several other research questions, including:
* What side effects may happen from taking REGN7508 or REGN9933
* How well do the study drugs reduce the risk of having a stroke
* How much of REGN7508 or REGN9933 is in the blood at different times
* Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)
Who can participate
Key Inclusion Criteria:
1. Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
2. Meets one of the following:
1. 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 Oral Anticoagulant (OAC) naïve or
2. CHA2DS2-VA score ≥3 or
3. CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
3. Must have a Prothrombin Time/International Normalization Ratio (PT/INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)
Key Exclusion Criteria:
1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
2. Has known moderate-to-severe mitral stenosis
3. Has had successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
4. Had an ischemic stroke within 2 days prior to randomization
5. Has Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 14 days prior to randomization or on dialysis or expected to be started as described in the protocol
6. Has a history of central nervous system bleeding within 30 days prior to randomization
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Interventions
REGN7508
DRUG
REGN9933
DRUG
Apixaban
DRUG
Locations
42
Canada (7)
Health sciences North - Cardiology
Greater Sudbury , Ontario
Viacar Recherches Cliniques Inc. - Cardiologie
Longueuil , Quebec
GA Research Associates Ltd.
Moncton , New Brunswick
Dr James Cha
Oshawa , Ontario
Heart Health Institute Research Inc. - Cardiology
Scarborough Village , Ontario
Diex Recherche Inc.
Sherbrooke , Quebec
Diex Recherche Trois-rivieres
Trois-Rivières , Quebec
United States (35)
PharmaTex Research
Amarillo , Texas
Health Sciences Research Building II
Atlanta , Georgia
Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)
Boston , Massachusetts
Alpine Research TC
Clinton , Utah
Nouvelle Clinical Research LLC
Cutler Bay , Florida
SEC Clinical Research
Dothan , Alabama
Eastern Shore Research Institute
Fairhope , Alabama
Profound Research LLC
Farmington Hills , Michigan
AA Medical Research Center (MRC)
Flint , Michigan
Mission Cardiovascular Research Institute
Fremont , California
Anderson Medical Research
Ft. Washington , Maryland
Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research
Greensboro , North Carolina
National Institute of California Heart and Vein Specialists