Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease (NCT07318610)
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)
🩺 Plain-English Summary (8th-Grade Level)
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
Who can join: Review the eligibility criteria below.
Location: Lake Martin Medical and Vascular Center — Alexander City, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- Lake Martin Medical and Vascular Center — Alexander City, Alabama
- Axsendo Clinical Research, Integrated Medical Services — Avondale, Arizona
- Applied Research Center of Arkansas — Little Rock, Arkansas
- Angel City Research, Inc. — Los Angeles, California
- Pacific Cardiovascular and Vein Institute — Oxnard, California
- Nature Coast Clinical Research - Cardiology — Crystal River, Florida
- Profound Research, Powers Health Medical Group — Munster, Indiana
- Cardiovascular Solutions — Shreveport, Louisiana
- Accellacare of Piedmont, Piedmont Healthcare — Mooresville, North Carolina
- Hightower Clinical — Oklahoma City, Oklahoma
- Apex Research Foundation, LLC — Jackson, Tennessee
- Tennova TCMC — Knoxville, Tennessee
- Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates — Tullahoma, Tennessee
- PharmaTex Research — Amarillo, Texas
- Vital Heart and Vein — Cypress, Texas
- Epic Medical Research — DeSoto, Texas
- Epic Medical Research-Plano — Plano, Texas
📞 Contact the Study Coordinator
Phone: (844) 734-6643
Email: clinicaltrials@regeneron.com
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Peripheral Artery Disease (PAD)
- The Chocolate Touch Study — Gainesville, Florida
- Hemodynamic Parameters in People With Atherosclerotic Vascular Disease Referred to a Secondary Prevention and Cardiovascular Rehabilitation Program — Lévis, Quebec
- Detecting Peripheral Artery Disease With the Pulse — Omaha, Nebraska
- Using Near-Infrared Light to Better Understand Peripheral Artery Disease — Arlington, Texas
- Serranator POINT FORCE Registry — Scottsdale, Arizona
Explore by condition: All Peripheral Artery Disease (PAD) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.