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RecruitingPhase 2

Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

Regeneron Pharmaceuticals · NCT07175428

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
1200
US sites recruiting
42
Study start
October 20, 2025
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation.

The aim of the study is to see how well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots.

The study is looking at several other research questions, including:

  • What side effects may happen from taking REGN7508 or REGN9933
  • How well do the study drugs reduce the risk of having a stroke
  • How much of REGN7508 or REGN9933 is in the blood at different times
  • Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)

Being studied: REGN7508; REGN9933; Apixaban

Conditions: Atrial Fibrillation (AF)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • 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 an International Normalization Ratio (INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

Key Exclusion Criteria

  • 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 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
  • Has a history of central nervous system bleeding within 30 days prior to randomization

Note: Other protocol-defined Inclusion/ Exclusion criteria apply

Recruiting US locations

Study contacts (from the official record)

  • Clinical Trials Administrator · 844-734-6643 · clinicaltrials@regeneron.com
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Safety in Adult Participants With Atrial Fibrillation Who Are… (NCT07175428) | Bored Studies