Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation

NCT07175428 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: R7508-CVA-2393
• Study Type: interventional
• Target: 1,200
• Locations: 2 countries
• Sites: 42

Brief Summary

This study is researching experimental drugs called REGN7508 and REGN9933. The study is focused on participants who have atrial fibrillation, which means that the heart beats too fast and unevenly. 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 well REGN7508 and REGN9933 work in patients that get medicine for their atrial fibrillation. The bleeding effects of REGN7508 and REGN9933 will be compared to another medicine (apixaban), which is available on the market to treat and prevent formation of blood clots. The study is looking at several other research questions, including:

• What side effects may happen from taking REGN7508 or REGN9933
• How well do the study drugs reduce the risk of having a stroke
• How much of REGN7508 or REGN9933 is in the blood at different times
• Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the drugs less effective or could lead to side effects)

Conditions

Atrial Fibrillation (AF)

Keywords

Bleeding; Stroke; Systemic embolism; Blood clots

Outcome Measures

Primary Outcomes (1)

• Incidence of any bleeding

  Defined as the composite of International Society on Thrombosis and Haemostasis (ISTH) major bleeding, ISTH Clinically Relevant Non-Major (CRNM) bleeding, or minor bleeding

  12 weeks

Secondary Outcomes (18)

• Incidence of the composite of ISTH major bleeding or ISTH CRNM bleeding

  12 weeks

• Incidence of ISTH major bleeding

  12 weeks

• Incidence of ISTH CRNM bleeding

  12 weeks

• Incidence of minor bleeding

  12 weeks

• Number of ISTH major bleeding events

  12 weeks

Study Arms (3)

REGN7508

EXPERIMENTAL

Drug: REGN7508

REGN9933

EXPERIMENTAL

Drug: REGN9933

Apixaban

ACTIVE COMPARATOR

Drug: Apixaban

Interventions

REGN7508 DRUG

Administered per the protocol

REGN7508

REGN9933 DRUG

Administered per the protocol

REGN9933

Apixaban DRUG

Administered per the protocol

Also known as: Eliquis

Apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Has AF or flutter (paroxysmal or persistent), not felt to be secondary to a reversible cause, and an indication for indefinite anticoagulation treatment as described in the protocol
• Meets one of the following:
• CHA2DS2-VA \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Thromboembolism (double points); V: Vascular disease; A: Age 65-74 years\] score ≥2 and Oral Anticoagulant (OAC) naïve or
• CHA2DS2-VA score ≥3 or
• CHA2DS2-VA score of 2 and at least 1 enrichment criteria as described in the protocol
• Must have a Prothrombin Time/International Normalization Ratio (PT/INR) \<2.5 at the time of randomization if taking warfarin or another Vitamin K Antagonist (VKA)

You may not qualify if:

• Has known moderate-to-severe mitral stenosis
• Had an ischemic stroke within 2 days prior to randomization
• Has Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 14 days prior to randomization or on dialysis or expected to be started as described in the protocol
• Has a history of central nervous system bleeding within 30 days prior to randomization

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (42)

SEC Clinical Research

Dothan, Alabama, 36305, United States

RECRUITING

Eastern Shore Research Institute

Fairhope, Alabama, 36532, United States

RECRUITING

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

RECRUITING

National Institute of California Heart and Vein Specialists

Huntington Beach, California, 92648, United States

RECRUITING

Profound Research LLC at Southern California Heart Specialists

Pasadena, California, 91105, United States

RECRUITING

Empire Clinical Research

Pomona, California, 91767, United States

RECRUITING

Northbay Clinical Research Center

Santa Rosa, California, 95405, United States

RECRUITING

Cardiology Associates Medical Group

Ventura, California, 93003, United States

RECRUITING

Interventional Cardiology Medical Group

West Hills, California, 91307, United States

RECRUITING

Nouvelle Clinical Research LLC

Cutler Bay, Florida, 33189, United States

RECRUITING

Inpatient Research Clinic LLC

Miami Lakes, Florida, 33014, United States

RECRUITING

Cardiovascular Center of Sarasota Foundation for Research and Education

Sarasota, Florida, 34239, United States

RECRUITING

Clinical Site Partners, LLC DBA Flourish Research

Winter Park, Florida, 32789, United States

RECRUITING

Health Sciences Research Building II

Atlanta, Georgia, 30322, United States

RECRUITING

NSC Research, Inc

Johns Creek, Georgia, 30024, United States

RECRUITING

Indiana University

Indianapolis, Indiana, 46202, United States

RECRUITING

Blue Coast Research Center, LLC

Indianapolis, Indiana, 46237, United States

RECRUITING

Franciscan Physician Network, Indiana Heart Physicians

Indianapolis, Indiana, 46237, United States

RECRUITING

Indiana Medical Research

Merrillville, Indiana, 46410, United States

RECRUITING

Reid Physician Associates

Richmond, Indiana, 47374, United States

RECRUITING

Monroe Research, LLC

West Monroe, Louisiana, 71291, United States

RECRUITING

Anderson Medical Research

Ft. Washington, Maryland, 20744, United States

RECRUITING

Beth Israel Lahey Health, Beth Israel Deaconess Medical Center (BIDMC)

Boston, Massachusetts, 02215, United States

RECRUITING

Profound Research LLC

Farmington Hills, Michigan, 48334, United States

RECRUITING

AA Medical Research Center (MRC)

Flint, Michigan, 48504, United States

RECRUITING

Moses Cone Hospital Operating Corporation dba Cone Health, Lebauer-Brodie Center for Cardiovascular Research

Greensboro, North Carolina, 27401, United States

RECRUITING

K&R Research LLC

Marion, Ohio, 43302, United States

RECRUITING

Advanced Medical Research

Maumee, Ohio, 43537, United States

RECRUITING

Monument Health Clinical Research

Rapid City, South Dakota, 57701, United States

RECRUITING

East Coast Institute for Research, Jefferson City

Jefferson City, Tennessee, 37760, United States

RECRUITING

PharmaTex Research

Amarillo, Texas, 79106, United States

RECRUITING

Complete Heart Care P.A.

McKinney, Texas, 75071, United States

RECRUITING

Permian Research Foundation

Odessa, Texas, 79761, United States

RECRUITING

Tyler Cardiovascular Consultants

Tyler, Texas, 75701, United States

RECRUITING

Alpine Research TC

Clinton, Utah, 84015, United States

RECRUITING

GA Research Associates Ltd.

Moncton, New Brunswick, E1G-1A7, Canada

RECRUITING

Health sciences North - Cardiology

Greater Sudbury, Ontario, P3E 5J1, Canada

RECRUITING

Dr James Cha

Oshawa, Ontario, L1J 2K1, Canada

RECRUITING

Heart Health Institute Research Inc. - Cardiology

Scarborough Village, Ontario, M1B 4Z8, Canada

RECRUITING

Viacar Recherches Cliniques Inc. - Cardiologie

Longueuil, Quebec, J4H 4B9, Canada

RECRUITING

Diex Recherche Inc.

Sherbrooke, Quebec, J1LOK3, Canada

RECRUITING

Diex Recherche Trois-rivieres

Trois-Rivières, Quebec, G9A 4P3, Canada

RECRUITING

MeSH Terms

Conditions

Atrial Fibrillation; Hemorrhage; Stroke; Thrombosis

Interventions

apixaban

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Embolism and Thrombosis

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clinical Trials Administrator

CONTACT

844-734-6643; clinicaltrials@regeneron.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 16, 2025
• Study Start: October 20, 2025
• Primary Completion (Estimated): February 9, 2027
• Study Completion (Estimated): April 21, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: When Regeneron has: * received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development * made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) * the legal authority to share the data, and * ensured the ability to protect participant privacy
• Access Criteria: Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

Locations

US (35); CA (7)