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 3, 2026 (Actual)
- Primary completion
- Mar 28, 2029 (Estimated)
- Completion
- Jun 26, 2029 (Estimated)
- Last update posted
- Oct 14, 2026
2026 – 2029
United States locations
- U.S. sites
- 43
- U.S. states
- 18
- U.S. cities
- 40
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| SEC Clinical Research | Dothan | Alabama | 36305 | Recruiting |
| Sun City Clinical Research | Glendale | Arizona | 85351 | Recruiting |
| Arkansas Cardiology P.A. | Little Rock | Arkansas | 72205 | 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 San Diego Cardiovascular Associates | La Jolla | California | 92037 | Recruiting |
| Valley Clinical Trials, LLC dba Flourish Research | Northridge | California | 91325 | Recruiting |
| Profound Research LLC at Southern California Heart Specialists | Pasadena | California | 91105 | Recruiting |
| FOMAT - Comprehensive Cardiovascular Care | Santa Maria | California | 93454 | Recruiting |
| Cardiology Associates Medical Group | Ventura | California | 93003 | Recruiting |
| Interventional Cardiology Medical Group | West Hills | California | 91307 | Recruiting |
| East Coast Institute for Research, Jacksonville | Jacksonville | Florida | 32216 | Recruiting |
| South Florida Research Organization LLC | Medley | Florida | 33166 | Recruiting |
| Sec Clinical Research | Pensacola | Florida | 32503 | Recruiting |
| Cardiovascular Center of Sarasota Foundation for Research and Education | Sarasota | Florida | 34239 | Recruiting |
| Clinical Site Partners, LLC DBA Flourish Research | Winter Park | Florida | 32789 | Recruiting |
| Atlanta Clinical Research Centers | Atlanta | Georgia | 30342 | Recruiting |
| NSC Research, Inc | Johns Creek | Georgia | 30024 | Recruiting |
| Franciscan Physician Network, Indiana Heart Physicians | Indianapolis | Indiana | 46237 | Recruiting |
| Indiana Medical Research | Merrillville | Indiana | 46410 | Recruiting |
| Profound Research, Powers Health Medical Group - Electrophysiology | Munster | Indiana | 46321 | Recruiting |
| Monroe Research, LLC | West Monroe | Louisiana | 71291 | Recruiting |
| Profound Research, Cardiology and Vascular Associates (CAVA) - Bloomfield Hills | Bloomfield Hills | Michigan | 48304 | Recruiting |
| Profound Research, Millennium Cardiology | Farmington Hills | Michigan | 48334 | Recruiting |
| Flint Clinical Research | Flint | Michigan | 48503 | Recruiting |
| AA Medical Research Center (MRC) | Flint | Michigan | 48504 | Recruiting |
| Jackson Heart Clinic | Jackson | Mississippi | 39216 | Recruiting |
| Super Health Pharmacy | Staten Island | New York | 10309 | Recruiting |
| Hawthorne Health, Moose Pharmacy of Concord | Concord | North Carolina | 28025 | Recruiting |
| K&R Research LLC | Marion | Ohio | 43302 | Recruiting |
| AnMed Health | Anderson | South Carolina | 29621 | Recruiting |
| Monument Health Clinical Research | Rapid City | South Dakota | 57701 | Recruiting |
| Tennessee Center for Clinical Trials | Tullahoma | Tennessee | 37388 | Recruiting |
| PharmaTex Research | Amarillo | Texas | 79106 | Recruiting |
| PanAmerican Clinical Research | Brownsville | Texas | 78520 | Recruiting |
| Southwest Family Medicine Associates | Dallas | Texas | 75235 | Recruiting |
| East Texas Cardiology | Houston | Texas | 77002 | Recruiting |
| Synergy Group Medical,LLC | Houston | Texas | 77036 | Recruiting |
| Synergy Groups Medical | Houston | Texas | 77061 | Recruiting |
| Heart Institute of East Texas | Lufkin | Texas | 75901 | Recruiting |
| Texas Institute of Cardiology PA | McKinney | Texas | 75071 | Recruiting |
| Synergy Group Medical, LLC | Missouri City | Texas | 77459 | Recruiting |
| Conquest Research | Vienna | Virginia | 22182 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
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 Oct 14, 2026 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT07430956 live on ClinicalTrials.gov.