Atrial Fibrillation (AF)
Conditions
Keywords
Bleeding, Stroke, Systemic embolism, Blood clots
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)
Interventions
DRUGREGN7508
Administered per the protocol
DRUGApixaban
Administered per the protocol
DRUGPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| Time to occurrence of fatal bleeding | Approximately 36 months |
| Number of ISTH major bleeding events | Approximately 36 months |
| Number of ISTH CRNM bleeding events | Approximately 36 months |
| Number of minor bleeding events | Approximately 36 months |
| Time to all-cause death | Approximately 36 months |
| Occurrence of Treatment-Emergent Adverse Events (TEAEs) | Approximately 39 months |
| Severity of TEAEs | Approximately 39 months |
| Occurrence of Anti-Drug Antibodies (ADA) to REGN7508 | Approximately 36 months |
| Magnitude of ADA to REGN7508 | Approximately 36 months |
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed