Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07626411
Phase
PHASE3
Status
Recruiting

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
Aug 10, 2026
Status verified
Aug 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

Locations (8)

FacilityCityStateZIPSite coordinators
SEC Clinical ResearchDothanAlabama36305-
Radin Cardiovascular Medical GroupNewport BeachCalifornia92663-
Southern California Heart SpecialistsPasadenaCalifornia91105-
Sec Clinical ResearchPensacolaFlorida32503-
Monroe Research, LLCWest MonroeLouisiana71291-
PharmaTex ResearchAmarilloTexas79106-
West Houston Area Clinical Trial Consultants, LLCHoustonTexas77094-
Permian Research FoundationOdessaTexas79761-

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