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New hope for stroke prevention in heart patients who Can't use standard meds

NCT ID NCT07430956

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study tests two experimental drugs, REGN7508 and REGN9933, to prevent strokes in people with atrial fibrillation (an irregular heartbeat) who cannot or choose not to take standard blood thinners. About 2,628 participants will receive one of the drugs or a placebo to see if they reduce the risk of stroke or blood clots. The goal is to find a safer option for those at high risk of bleeding.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 2,628 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2026

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause 2. At moderate to high risk for stroke defined as: 1. CHA2DS2-VA \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\] score ≥4 OR 2. CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol 3. Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol Key Exclusion Criteria: 1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion) 2. Had an ischemic stroke within 2 days prior to randomization 3. Has persistent, uncontrolled hypertension (per investigator's discretion) 4. Has a history of Central Nervous System (CNS) bleeding within 30 days prior to randomization 5. Has a life expectancy less than 12 months 6. Has participated in a prior Factor XI (FXI) inhibitor study Note: Other protocol-defined Inclusion/ Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

atrial fibrillation atrial flutter pulmonary embolism thrombotic disease venous thromboembolism ischemic stroke prevention target

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atrial fibrillation (AF)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    35 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AA Medical Research Center (MRC)

    RECRUITING

    Flint, Michigan, 48504, United States

  • AnMed Health

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Arkansas Cardiology P.A.

    RECRUITING

    Little Rock, Arkansas, 72205, United States

  • Atlanta Clinical Research Centers

    RECRUITING

    Atlanta, Georgia, 30342, United States

  • Cardiology Associates Medical Group

    RECRUITING

    Ventura, California, 93003, United States

  • Cardiovascular Center of Sarasota Foundation for Research and Education

    RECRUITING

    Sarasota, Florida, 34239, United States

  • Clinical Site Partners, LLC DBA Flourish Research

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Conquest Research

    RECRUITING

    Vienna, Virginia, 22182, United States

  • East Texas Cardiology

    RECRUITING

    Houston, Texas, 77002, United States

  • Hawthorne Health, Moose Pharmacy of Concord

    RECRUITING

    Concord, North Carolina, 28025, United States

  • Heart Institute of East Texas

    RECRUITING

    Lufkin, Texas, 75901, United States

  • Indiana Medical Research

    RECRUITING

    Merrillville, Indiana, 46410, United States

  • Interventional Cardiology Medical Group

    RECRUITING

    West Hills, California, 91307, United States

  • K&R Research LLC

    RECRUITING

    Marion, Ohio, 43302, United States

  • Mission Cardiovascular Research Institute

    RECRUITING

    Fremont, California, 94538, United States

  • Monroe Research, LLC

    RECRUITING

    West Monroe, Louisiana, 71291, United States

  • Monument Health Clinical Research

    RECRUITING

    Rapid City, South Dakota, 57701, United States

  • NSC Research, Inc

    RECRUITING

    Johns Creek, Georgia, 30024, United States

  • National Institute of California Heart and Vein Specialists

    RECRUITING

    Huntington Beach, California, 92648, United States

  • PanAmerican Clinical Research

    RECRUITING

    Brownsville, Texas, 78520, United States

  • PharmaTex Research

    RECRUITING

    Amarillo, Texas, 79106, United States

  • Profound Research LLC at San Diego Cardiovascular Associates

    RECRUITING

    La Jolla, California, 92037, United States

  • Profound Research LLC at Southern California Heart Specialists

    RECRUITING

    Pasadena, California, 91105, United States

  • Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills

    RECRUITING

    Bloomfield Hills, Michigan, 48304, United States

  • Profound Research, Millennium Cardiology

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • SEC Clinical Research

    RECRUITING

    Dothan, Alabama, 36305, United States

  • Sec Clinical Research

    RECRUITING

    Pensacola, Florida, 32503, United States

  • South Florida Research Organization LLC

    RECRUITING

    Medley, Florida, 33166, United States

  • Southwest Family Medicine Associates

    RECRUITING

    Dallas, Texas, 75235, United States

  • Super Health Pharmacy

    RECRUITING

    Staten Island, New York, 10309, United States

  • Synergy Group Medical, LLC

    RECRUITING

    Missouri City, Texas, 77459, United States

  • Synergy Group Medical,LLC

    RECRUITING

    Houston, Texas, 77036, United States

  • Synergy Groups Medical

    RECRUITING

    Houston, Texas, 77061, United States

  • Tennessee Center for Clinical Trials

    RECRUITING

    Tullahoma, Tennessee, 37388, United States

  • Texas Institute of Cardiology PA

    RECRUITING

    McKinney, Texas, 75071, United States

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Other studies related to the condition(s) this trial covers.