ROXI-EVEREST

Currently Recruiting: Participants and Sites

Study Drug/Intervention: REGN7508/APIXABAN

Anticipated Sample Size: Approximately 15,364 Participants

Study Timeline: This study is expected to conclude in January 2030.

ClinicalTrials.gov ID: NCT07626411

Study Objective

The ROXI-EVEREST study goal is to demonstrate that REGN7508 is non-inferior to apixaban with respect to the risk of stroke or systemic embolism and is superior to apixaban with respect to the risk of ISTH major bleeding or ISTH CRNM bleeding in participants with AF at risk for stroke and/or systemic embolism.

Unique Aspects

This project is one of three studies within the ROXI Program space. Participants will conduct at-home administration of study interventions after an initial in-clinic visit (V1) at which participants are provided training by the investigator.

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

Participants with AF at risk for stroke and/or systemic embolism.

Study Sites

Approximately 45 sites throughout the United States and Japan. Visit the ClinicalTrials.gov Study Details page to view all locations.

Individual participants could be in the study for approximately 14 to 39 months. The overall study duration is expected to be approximately 39 months.

Follow-Up

The 90-day follow-up period includes open-label apixaban administration from the end-of-treatment visit to the end-of-study visit.

Regeneron Pharmaceuticals, Inc.

• Study Chair: Manesh Patel, MD
• Principal Investigator: John Alexander, MD
• Project Lead: Hirra Zahir, MBA