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

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

First listed

Feb 24, 2026

Start date

Apr 3, 2026

Status verified

Sep 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

• Clinical Trials Administrator
  844-734-6643
  [email protected]

Locations (35)

Find similar trials in Dothan, AL

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