Status:
RECRUITING
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Atrial Fibrillation (AF)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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. RE...
Eligibility Criteria
Inclusion
- Key
- 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
- 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 Oral Anticoagulant (OAC) naïve or
- CHA2DS2-VA score ≥3 or
- CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
- 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
- Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement 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 in the protocol
- Had an ischemic stroke within 2 days prior to randomization
- 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
- Has a history of central nervous system bleeding within 30 days prior to randomization
- Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Key Trial Info
Start Date :
October 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 21 2027
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT07175428
Start Date
October 20 2025
End Date
April 21 2027
Last Update
January 7 2026
Active Locations (20)
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1
SEC Clinical Research - Cardiology
Dothan, Alabama, United States, 36305
2
Eastern Shore Research Institute, LLC
Fairhope, Alabama, United States, 36532
3
Mission Cardiovascular Research Institute
Fremont, California, United States, 94538
4
National Institute of Clinical Research, Inc. / California Heart Specialists - Cardiology
Huntington Beach, California, United States, 92648