Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: REGN7508, Apixaban, Placebo.
- Who it may be relevant to
- Registry conditions: Atrial Fibrillation (AF). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508, a Monoclonal Antibody Against Factor XI, Versus Apixaban in Participants With Atrial Fibrillation (ROXI-EVEREST)
Overview
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)
Interventions
- Drug REGN7508
Administered per the protocol - Drug Apixaban
Administered per the protocol - Drug Placebo
Administered per the protocol
Primary outcome measures
- Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type) or systemic embolism [Time frame: 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 [Time frame: Approximately 36 months]
Secondary outcome measures (12)
- Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or ISTH CRNM bleeding [Time frame: Approximately 36 months]
- Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, or ISTH major bleeding [Time frame: Approximately 36 months]
- Time to first occurrence of stroke (ischemic, hemorrhagic, or of unspecified type), systemic embolism, ISTH major bleeding, or all-cause death [Time frame: Approximately 36 months]
- Time to first occurrence of ISTH major bleeding [Time frame: Approximately 36 months]
- Time to first occurrence of hemorrhagic stroke, intracerebral hemorrhage, or hemorrhagic transformation of an ischemic stroke [Time frame: Approximately 36 months]
- Time to occurrence of fatal bleeding [Time frame: Approximately 36 months]
- Number of ISTH major bleeding events [Time frame: Approximately 36 months]
- Number of ISTH CRNM bleeding events [Time frame: Approximately 36 months]
- Number of minor bleeding events [Time frame: Approximately 36 months]
- Time to all-cause death [Time frame: Approximately 36 months]
- Occurrence of Treatment-Emergent Adverse Events (TEAEs) [Time frame: Approximately 39 months]
- Severity of TEAEs [Time frame: Approximately 39 months]
Eligibility criteria
Inclusion criteria
- 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)
Exclusion criteria
- Has a mechanical heart valve prosthesis (Note: transcatheter aortic valve replacement is not an exclusion)
- Has known moderate-to-severe mitral stenosis
- 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
- 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
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07626411 · R7508-CVA-24114 · 2025-521617-97-00