Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Public ClinicalTrials.gov record NCT07318610. 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, Multicenter, Randomized Study to Evaluate the Efficacy and Safety of REGN7508 and REGN9933, Monoclonal Antibodies Against Factor XI, in Participants With Recent Lower Extremity Revascularization for Symptomatic Peripheral Artery Disease (ROXI-PALISADE)
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. The study is focused on people who have Peripheral Artery Disease (PAD), which means that the blood vessels in their arms and legs have become too narrow. People with PAD have a higher risk of getting blood clots after procedures like Lower Extremity Revascularization (LER), a procedure to improve blood flow in the legs and feet. The aim of this study is to see how well REGN7508 and REGN9933 prevent life-threatening blood clots in participants with PAD who have recently had LER. The effects of REGN7508 and REGN9933, individually, will also be compared to rivaroxaban and a placebo. The study is looking at several other research questions, including: * What side effects might happen from taking the study drugs and how do they compare to the side effects of rivaroxaban * How much study drug is in the blood at different times * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects) * If the study drugs affect the ability of the blood to clot normally
Study identification
- NCT ID
- NCT07318610
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 7,050 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
- Jul 9, 2026
- Primary completion
- Aug 17, 2029
- Completion
- Nov 15, 2029
- Last update posted
- Aug 18, 2026
2026 – 2029
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Lake Martin Medical and Vascular Center | Alexander City | Alabama | 35010 | Recruiting |
| Axsendo Clinical Research, Integrated Medical Services | Avondale | Arizona | 85392 | Recruiting |
| Applied Research Center of Arkansas | Little Rock | Arkansas | 72205 | Recruiting |
| Angel City Research, Inc. | Los Angeles | California | 90010 | Recruiting |
| Pacific Cardiovascular and Vein Institute | Oxnard | California | 93036 | Recruiting |
| Nature Coast Clinical Research - Cardiology | Crystal River | Florida | 34429 | Recruiting |
| Profound Research, Powers Health Medical Group | Munster | Indiana | 46321 | Recruiting |
| Cardiovascular Solutions | Shreveport | Louisiana | 71103 | Recruiting |
| Accellacare of Piedmont, Piedmont Healthcare | Mooresville | North Carolina | 28117 | Recruiting |
| Hightower Clinical | Oklahoma City | Oklahoma | 73102 | Recruiting |
| Apex Research Foundation, LLC | Jackson | Tennessee | 38301 | Recruiting |
| Tennova TCMC | Knoxville | Tennessee | 37934 | Recruiting |
| Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates | Tullahoma | Tennessee | 37388 | Recruiting |
| PharmaTex Research | Amarillo | Texas | 79106 | Recruiting |
| Vital Heart and Vein | Cypress | Texas | 77429 | Recruiting |
| Epic Medical Research | DeSoto | Texas | 75115 | Recruiting |
| Epic Medical Research-Plano | Plano | Texas | 75093 | 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 NCT07318610, 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 Aug 18, 2026 · Synced Sep 3, 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 NCT07318610 live on ClinicalTrials.gov.