Stroke and Systemic Embolism Prevention in Adult Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable
Public ClinicalTrials.gov record NCT07430956. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Master Protocol for a Phase 3, Randomized, Multicenter, Double-blind Study to Assess Stroke and Systemic Embolism Prevention With REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, Versus Placebo in Participants With Atrial Fibrillation for Whom Oral Anticoagulation is Unsuitable (ROXI-INCLINE)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 effects may happen from taking REGN7508 or REGN9933 * How well does REGN7508 or REGN9933 lower the risk of having an ischemic stroke and/or systemic embolism compared to the placebo * How well does REGN7508 or REGN9933 lower the risk of having a major health problem affecting heart and blood circulation compared to placebo * How well does REGN7508 or REGN9933 lower the risk of death compared to placebo * How much REGN7508 or REGN9933 is in the blood at different times * Whether the body makes antibodies against REGN7508 or REGN9933 (which could make the study drugs less effective or could lead to side effects)
Study identification
- NCT ID
- NCT07430956
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 2,628 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Apr 2, 2026
- Primary completion
- Mar 27, 2029
- Completion
- Jun 25, 2029
- Last update posted
- Jun 22, 2026
2026 – 2029
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 18
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SEC Clinical Research | Dothan | Alabama | 36305 | Recruiting |
| Mission Cardiovascular Research Institute | Fremont | California | 94538 | Recruiting |
| National Institute of California Heart and Vein Specialists | Huntington Beach | California | 92648 | Recruiting |
| Profound Research LLC at Southern California Heart Specialists | Pasadena | California | 91105 | Recruiting |
| Cardiology Associates Medical Group | Ventura | California | 93003 | Recruiting |
| Interventional Cardiology Medical Group | West Hills | California | 91307 | Recruiting |
| South Florida Research Organization LLC | Medley | Florida | 33166 | Recruiting |
| Sec Clinical Research | Pensacola | Florida | 32503 | Recruiting |
| Clinical Site Partners, LLC DBA Flourish Research | Winter Park | Florida | 32789 | Recruiting |
| NSC Research, Inc | Johns Creek | Georgia | 30024 | Recruiting |
| Monroe Research, LLC | West Monroe | Louisiana | 71291 | Recruiting |
| Profound Research, Millennium Cardiology | Farmington Hills | Michigan | 48334 | Recruiting |
| AA Medical Research Center (MRC) | Flint | Michigan | 48504 | Recruiting |
| K&R Research LLC | Marion | Ohio | 43302 | Recruiting |
| AnMed Health | Anderson | South Carolina | 29621 | Recruiting |
| PharmaTex Research | Amarillo | Texas | 79106 | Recruiting |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | Recruiting |
| Texas Institute of Cardiology PA | McKinney | Texas | 75071 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07430956, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 22, 2026 · Synced Sep 7, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07430956 live on ClinicalTrials.gov.