Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07626411
Phase
PHASE3
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • REGN7508 — DRUG
    Administered per the protocol
  • Apixaban — DRUG
    Administered per the protocol
  • Placebo — DRUG
    Administered per the protocol

Study Details

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)

Key Dates

First listed
Jun 4, 2026
Start date
Jul 31, 2026
Status verified
May 2026
Primary completion
Sep 11, 2029
Completion
Dec 10, 2029

Study Design

Enrollment
15,364 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: REGN7508 + Placebo
  • Active Comparator: Apixaban + Placebo

Primary Outcome Measure

Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism [ Time Frame: Approximately 36 months ]

Central Contacts

Related Studies