Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT07430956
Phase
PHASE3
Status
Recruiting
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Conditions

  • Atrial Fibrillation (AF)

Eligibility Criteria

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

Interventions

  • REGN7508 — DRUG
    Administered per the protocol
  • REGN9933 — DRUG
    Administered per the protocol
  • Placebo — DRUG
    Administered per the protocol

Study Details

This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots. 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 effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners. The study is looking at several other research questions, including: * What side effects may happen from taking REGN7508 or REGN9933 * How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo * How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo * How well does REGN7508 or REGN9933 lower the risk of death compared to placebo * How much REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)

Key Dates

Start date
Apr 3, 2026
Status verified
May 2026
Primary completion
Mar 28, 2029
Completion
Jun 26, 2029

Study Design

Enrollment
2,628 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: REGN7508
  • Experimental: REGN9933
  • Placebo Comparator: Placebo

Primary Outcome Measure

Time to first occurrence of ischemic stroke or systemic embolism [ Time Frame: Up to 36 months ]

Central Contacts

Locations (13)

FacilityCityStateZIPSite coordinators
SEC Clinical ResearchDothanAlabama36305-
Mission Cardiovascular Research InstituteFremontCalifornia94538-
National Institute of California Heart and Vein SpecialistsHuntington BeachCalifornia92648-
Profound Research LLC at Southern California Heart SpecialistsPasadenaCalifornia91105-
Cardiology Associates Medical GroupVenturaCalifornia93003-
Interventional Cardiology Medical GroupWest HillsCalifornia91307-
South Florida Research Organization LLCMedleyFlorida33166-
Clinical Site Partners, LLC DBA Flourish ResearchWinter ParkFlorida32789-
NSC Research, IncJohns CreekGeorgia30024-
Monroe Research, LLCWest MonroeLouisiana71291-
AA Medical Research Center (MRC)FlintMichigan48504-
K&R Research LLCMarionOhio43302-
PharmaTex ResearchAmarilloTexas79106-

Find similar trials in Dothan, AL

By research site
SEC Clinical Research· Dothan, ALMission Cardiovascular Research Institute· Fremont, CANational Institute of California Heart and Vein Specialists· Huntington Beach, CAProfound Research LLC at Southern California Heart Specialists· Pasadena, CACardiology Associates Medical Group· Ventura, CAInterventional Cardiology Medical Group· West Hills, CA

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