Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation

NCT07626411 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: R7508-CVA-241142025-521617-97-00
• Study Type: interventional
• Target: 15,364
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is researching an experimental drug called REGN7508 (called "study drug") and how it compares against another treatment called apixaban. The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. The aim of the study is to see how safe and effective REGN7508 is in preventing stroke and/or systemic embolism in participants with atrial fibrillation and how it compares against participants that will receive apixaban in this study. The study is looking at several other research questions, including:

• What side effects may happen from taking the study drug
• Whether the body makes antibodies against the study drug (which could make the study drug less effective or could lead to side effects)

Conditions

Atrial Fibrillation (AF)

Keywords

Bleeding; Stroke; Systemic embolism; Blood clots

Outcome Measures

Primary Outcomes (2)

• Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism

  Approximately 36 months

• Time to first occurrence of International Society on Thrombosis and Haemostasis (ISTH) major bleeding or ISTH Clinically Relevant Non-Major (CRNM) bleeding

  Approximately 36 months

Secondary Outcomes (14)

• Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding

  Approximately 36 months

• Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding

  Approximately 36 months

• Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death

  Approximately 36 months

• Time to first occurrence of ISTH major bleeding

  Approximately 36 months

• Time to first occurrence of hemorrhagic stroke, intracerebral hemorrhage, or hemorrhagic transformation of an ischemic stroke

  Approximately 36 months

Study Arms (2)

REGN7508 + Placebo

EXPERIMENTAL

Drug: REGN7508; Drug: Placebo

Apixaban + Placebo

ACTIVE COMPARATOR

Drug: Apixaban; Drug: Placebo

Interventions

REGN7508 DRUG

Administered per the protocol

Also known as: cenvacibart

REGN7508 + Placebo

Apixaban DRUG

Administered per the protocol

Apixaban + Placebo

Placebo DRUG

Administered per the protocol

Apixaban + Placebo; REGN7508 + Placebo

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 considered 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 \[C: Congestive heart failure; H: Hypertension; A2: Age ≥75 years (double points); D: Diabetes mellitus; S2: Stroke or TIA or Systemic embolism (double points); V: Vascular disease; A: Age 65-74 years\] 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 an International Normalized Ratio (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 persistent, uncontrolled hypertension (per investigator's discretion)
• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

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 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 4, 2026
• Study Start (Estimated): July 31, 2026
• Primary Completion (Estimated): September 11, 2029
• Study Completion (Estimated): December 10, 2029
• Last Updated: June 4, 2026

Record last verified: 2026-05

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