Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for
This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in
| Condition(s) | Atrial Fibrillation (AF) |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | This study is researching 2 different experimental drugs called REGN7508 and REGN9933 (called "study drugs"). The study is focused on people who have atrial fibrillation, which means that the heart beats too fast and unevenly. When this happens, blood cannot move smoothly through the heart; it can slow down or pool in one spot, which can lead to the formation of blood clots. REGN7508 and REGN9933 are designed to help stop blood clots forming in patients with atrial fibrillation. The aim of the study is to see how effective and safe REGN7508 and REGN9933, individually, are in preventing ischemic stroke or systemic embolism in people with atrial fibrillation who cannot or may choose to not take blood thinners. The study is looking at several other research questions, including: * What side e |
| Who can participate | Key Inclusion Criteria: 1. Has AF or flutter (paroxysmal or persistent), not considered to be secondary to a reversible cause 2. At moderate to high risk for stroke defined as: 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 ≥4 OR 2. CHA2DS2-VA score of 3 AND at least 1 enrichment criteria as described in the protocol 3. Shared decision making between the participant and provider determining that the bleeding risk of Oral Anticoagulant (OAC) therapy outweighs the benefits, making the participant unsuitable for OAC therapy as described in the protocol Key Exclusion Criteria: 1. Has a mechanical heart valve prosthesis ( |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Regeneron Pharmaceuticals |
| Locations | Dothan, Alabama, United States; Fremont, California, United States; Huntington Beach, California, United States; Pasadena, California, United States; Ventura, California, United States; West Hills, California, United States (+7 more sites) |
| Start date | 2026-04-03 |
| NCT ID | NCT07430956 |
| Official listing | https://clinicaltrials.gov/study/NCT07430956 |