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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-521617-97-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| REGN7508 + Placebo | Experimental |
| |
| Apixaban + Placebo | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN7508 | Drug | Administered per the protocol |
|
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Key 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:
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:
Note: Other protocol-defined Inclusion/ Exclusion criteria apply
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
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All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
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
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| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| D006470 | Hemorrhage |
| D020521 | Stroke |
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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| Apixaban | Drug | Administered per the protocol |
|
| Placebo | Drug | Administered per the protocol |
|
| 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 |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D016769 | Embolism and Thrombosis |