Preventing stroke and systemic embolism in adults with atrial fibrillation using REGN7508 compared with apixaban

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this phase 3 trial, adults with atrial fibrillation are randomized to REGN7508, apixaban, or placebo to compare safety and effectiveness in preventing stroke and systemic embolism. The study also examines side effects and whether the body develops antibodies against REGN7508. Participants must have AF with an indication for long-term anticoagulation and meet specific risk criteria, with exclusions including mechanical heart valves and certain valve conditions. Sites are located in Alabama, and Regeneron is the lead sponsor with no listed collaborators.

Why it matters

Who can join: the full rules

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

Where it's running

• Advanced Cardiovascular
  Alexander City, Alabama, United States Recruiting
• SEC Clinical Research
  Dothan, Alabama, United States Recruiting
• Eastern Shore Research Institute
  Fairhope, Alabama, United States Recruiting
• West Valley Clinical Trials
  Glendale, Arizona, United States Recruiting
• Scottsdale Clinical Trials
  Scottsdale, Arizona, United States Recruiting
• Arkansas Cardiology P.A.
  Little Rock, Arkansas, United States Recruiting

+16 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.