Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation (ROXI-EVEREST)

Regeneron Pharmaceuticals

Status and phase: Not yet enrolling; Phase 3

Conditions: Atrial Fibrillation (AF)

Treatments: Drug: Placebo; Drug: Apixaban; Drug: REGN7508

Study type: Interventional

Funder types: Industry

Identifiers

NCT07626411

2025-521617-97-00 (EU Trial (CTIS) Number)

R7508-CVA-24114

Details and patient eligibility

About

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)

Enrollment: 15,364 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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15,364 participants in 2 patient groups

REGN7508 + Placebo

Experimental group

Treatment:

Drug: REGN7508

Drug: Placebo

Apixaban + Placebo

Active Comparator group

Treatment:

Drug: Apixaban

Drug: Placebo