Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

Purpose

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study. The study is looking at several other research questions, including: - What side effects may happen from taking the study drug - Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Condition

  • Atrial Fibrillation (AF)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Has AF or flutter (paroxysmal or persistent), not considered 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 Systemic embolism (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 an International Normalized Ratio (INR) <2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

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 a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization 4. Had an ischemic stroke within 2 days prior to randomization 5. Has persistent, uncontrolled hypertension (per investigator's discretion) 6. Has estimated Glomerular Filtration Rate (eGFR) <15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from randomization Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
REGN7508 + Placebo
  • Drug: REGN7508
    Administered per the protocol
    Other names:
    • cenvacibart
  • Drug: Placebo
    Administered per the protocol
Active Comparator
Apixaban + Placebo
  • Drug: Apixaban
    Administered per the protocol
  • Drug: Placebo
    Administered per the protocol

Recruiting Locations

SEC Clinical Research
Dothan, Alabama 36305

Radin Cardiovascular Medical Group
Newport Beach, California 92663

Southern California Heart Specialists
Pasadena, California 91105

Sec Clinical Research
Pensacola, Florida 32503

Monroe Research, LLC
West Monroe, Louisiana 71291

PharmaTex Research
Amarillo, Texas 79106

West Houston Area Clinical Trial Consultants, LLC
Houston, Texas 77094

Permian Research Foundation
Odessa, Texas 79761

More Details

Status
Recruiting
Sponsor
Regeneron Pharmaceuticals

Study Contact

Clinical Trials Administrator
844-734-6643
clinicaltrials@regeneron.com