Preventing stroke and systemic embolism in adults with atrial fibrillation who can't use oral blood thinners

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

This Phase 3, randomized, placebo-controlled trial compares REGN7508 and REGN9933, given separately, against placebo in adults with atrial fibrillation judged unsuitable for oral anticoagulation. Eligible participants meet defined CHA2DS2-VA stroke-risk criteria and have a shared decision with their clinician that oral anticoagulants are inappropriate. The study tracks ischemic stroke, systemic embolism, and safety outcomes to compare event rates and side effects between each investigational drug and placebo. Enrollment occurs at several U.S. clinical research centers.

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
2. At moderate to high risk for stroke defined as:

   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 ≥4 OR
   2. CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol
3. Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol

Key Exclusion Criteria:

1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
2. Had an ischemic stroke within 2 days prior to randomization
3. Has persistent, uncontrolled hypertension (per investigator's discretion)
4. Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization
5. Has a life expectancy less than 12 months
6. Has participated in a prior Factor XI (FXI) inhibitor study

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Where it's running

• SEC Clinical Research
  Dothan, Alabama, United States Recruiting
• Sun City Clinical Research
  Glendale, Arizona, United States Recruiting
• Arkansas Cardiology P.A.
  Little Rock, Arkansas, United States Recruiting
• Mission Cardiovascular Research Institute
  Fremont, California, United States Recruiting
• National Institute of California Heart and Vein Specialists
  Huntington Beach, California, United States Recruiting
• Profound Research LLC at San Diego Cardiovascular Associates
  La Jolla, California, United States Recruiting

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.