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New antibody drug aims to prevent strokes in irregular heartbeat

NCT ID NCT07626411

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 17, 2026 · Updated 4 times

Summary

This large phase 3 trial tests an experimental drug, REGN7508, against the standard blood thinner apixaban for preventing strokes in people with atrial fibrillation (an irregular heartbeat). The study will enroll over 15,000 participants to compare how well each drug prevents strokes and serious bleeding. The goal is to see if REGN7508 is a safe and effective alternative.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
REGN7508 (cenvacibart), a monoclonal antibody
What this could lead to
If successful, this could offer a new, potentially safer option for preventing strokes in people with atrial fibrillation.
What could go wrong
This is a large phase 3 trial, but the drug is still experimental. It may not prove safer or more effective than apixaban, and there is a risk of unexpected side effects.

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 15,364 people

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

Started

Aug 2026

Expected to finish

Dec 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, and an indication for indefinite anticoagulation treatment as described in the protocol 2. Meets one of the following: 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 ≥2 and Oral Anticoagulant (OAC) naïve OR 2. CHA2DS2-VA score ≥3 OR 3. CHA2DS2-VA score of 2 AND at least 1 enrichment criteria as described in the protocol 3. Must have an International Normalized Ratio (INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA) Key Exclusion Criteria: 1. Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion) 2. Has known moderate-to-severe mitral stenosis 3. Has had a successful ablation therapy without documented recurrent AF or a participant after Left Atrial Appendage (LAA) occlusion/exclusion or plan for ablation or LAA occlusion/exclusion within the next 6 months starting from randomization 4. Had an ischemic stroke within 2 days prior to randomization 5. Has persistent, uncontrolled hypertension (per investigator's discretion) 6. Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m2 within 30 days prior to randomization or is on dialysis or expected to be started on dialysis within the next 6 months starting from randomization Note: Other protocol-defined Inclusion/ Exclusion criteria apply

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Conditions

The condition(s) this trial relates to.

atrial fibrillation Hemorrhage thrombotic disease stroke disorder 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

    32 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

  • Advanced Cardiovascular

    RECRUITING

    Alexander City, Alabama, 35010, United States

  • Anderson Medical Research

    RECRUITING

    Ft. Washington, Maryland, 20744, 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

  • Carient Heart & Vascular

    RECRUITING

    Manassas, Virginia, 20109, United States

  • Conquest Research

    RECRUITING

    Vienna, Virginia, 22182, United States

  • Hawthorne Health, Moose Pharmacy of Concord

    RECRUITING

    Concord, North Carolina, 28025, 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

  • NSC Research, Inc

    RECRUITING

    Johns Creek, Georgia, 30024, United States

  • Nouvelle Clinical Research LLC

    RECRUITING

    Cutler Bay, Florida, 33189, United States

  • PanAmerican Clinical Research

    RECRUITING

    Brownsville, Texas, 78520, United States

  • Permian Research Foundation

    RECRUITING

    Odessa, Texas, 79761, 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, 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

  • Profound Research, Powers Health Medical Group - Electrophysiology

    RECRUITING

    Munster, Indiana, 46321, United States

  • Radin Cardiovascular Medical Group

    RECRUITING

    Newport Beach, California, 92663, United States

  • SEC Clinical Research

    RECRUITING

    Dothan, Alabama, 36305, United States

  • Sec Clinical Research

    RECRUITING

    Pensacola, Florida, 32503, United States

  • Southern California Heart Specialists

    RECRUITING

    Pasadena, California, 91105, United States

  • Sun City Clinical Research

    RECRUITING

    Glendale, Arizona, 85351, 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 Groups Medical

    RECRUITING

    Houston, Texas, 77061, United States

  • Tennessee Center for Clinical Trials

    RECRUITING

    Tullahoma, Tennessee, 37388, United States

  • Valley Clinical Trials, LLC dba Flourish Research

    RECRUITING

    Northridge, California, 91325, United States

  • West Houston Area Clinical Trial Consultants, LLC

    RECRUITING

    Houston, Texas, 77094, United States

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