Safety of two new clot-preventing medicines for adults with atrial fibrillation on anticoagulation

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 2 interventional study, adults with atrial fibrillation who require indefinite anticoagulation are assigned to receive REGN7508, REGN9933, or the approved anticoagulant apixaban. The study compares bleeding events, stroke and systemic embolism rates, and records side effects to characterize safety and tolerability. Investigators will also measure drug concentrations over time and check for antibodies the body might make against the investigational medicines. Key enrollment criteria include CHA2DS2-VA score thresholds and an INR <2.5 at randomization for participants on warfarin.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

1. 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
2. Meets one of the following:

   1. CHA2DS2-VA \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\] 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 Normalization 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 successful ablation therapy or Left Atrial Appendage (LAA) occlusion/exclusion, or planned ablation or LAA occlusion/exclusion as described in the protocol
4. Had an ischemic stroke within 2 days prior to randomization
5. Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 30 days prior to randomization or on dialysis or expected to be started as described in the protocol
6. Has a history of central nervous system bleeding within 30 days prior to randomization

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Where it's running

• SEC Clinical Research
  Dothan, Alabama, United States Recruiting
• Eastern Shore Research Institute
  Fairhope, Alabama, United States Recruiting
• Valley Clinical Trials, Inc
  Covina, California, United States Recruiting
• North Coast Cardiology
  Encinitas, California, 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

+41 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.