NCT07626411 Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
| NCT ID | NCT07626411 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Regeneron Pharmaceuticals |
| Condition | Atrial Fibrillation (AF) |
| Study Type | INTERVENTIONAL |
| Enrollment | 15,364 participants |
| Start Date | 2026-08-10 |
| Primary Completion | 2029-09-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 15,364 participants in total. It began in 2026-08-10 with a primary completion date of 2029-09-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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)
Eligibility Criteria
Key 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) 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 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
Contact & Investigator
Clinical Trial Management
STUDY DIRECTOR
Regeneron Pharmaceuticals
Frequently Asked Questions
Who can join the NCT07626411 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Atrial Fibrillation (AF). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07626411 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 15,364 participants.
Is NCT07626411 currently recruiting?
Yes, NCT07626411 is actively recruiting participants. Contact the research team at clinicaltrials@regeneron.com for enrollment information.
Where is the NCT07626411 trial being conducted?
This trial is being conducted at Dothan, United States, Newport Beach, United States, Pasadena, United States, Pensacola, United States and 4 additional locations.
Who is sponsoring the NCT07626411 clinical trial?
NCT07626411 is sponsored by Regeneron Pharmaceuticals. The principal investigator is Clinical Trial Management at Regeneron Pharmaceuticals. The trial plans to enroll 15,364 participants.
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