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Clinical Trials in the USA / NCT07318610
Recruiting Phase 3

Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease

NCT07318610 · tracked via the Priya Life Science USA tracker
Sponsor
Regeneron Pharmaceuticals
Phase
Phase 3
Started
2026-07-10
Last updated
2026-10-22

Condition(s) studied

Peripheral Artery Disease (PAD)

Investigational drug(s) / intervention(s)

REGN7508 →REGN9933 →PlaceboRivaroxaban →

REGN7508: Administered per the protocol

REGN9933: Administered per the protocol

Placebo: Administered per the protocol

Rivaroxaban: Administered per the protocol

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Key Inclusion Criteria: 1. Successful LER distal to the external iliac artery for ischemia due to atherosclerotic disease within 10 days prior to randomization as described in the protocol 2. At least 1 of the following enrichment factors for major thrombotic vascular events: 1. Bypass with prosthetic graft 2. Endovascular treatment with stenting 3. Target lesion length \>15 cm 4. History of LER or amputation for PAD prior to qualifying LER 5. Type 2 diabetes mellitus requiring pharmacologic treatment 6. Comorbid symptomatic coronary artery disease as described in the protocol 7. Chronic kidney disease as described in the protocol 8. Age ≥75 years Key Exclusion Criteria: 1. Has any active clinical condition requiring chronic therapeutic anticoagulation after the index revascularization including known triple positive antiphospholipid syndrome 2. Has known bleeding diathesis, platelet count \<50,000/mm\^3 or history of non-traumatic intracerebral hemorrhage, known cerebral amyloid angiopathy, or known unrepaired cerebrovascular malformations 3. Has recent coronary revascularization as described in the protocol 4. For Cohort 2 only: Has estimated Glomerular Filtration Rate (eGFR) \<15 mL/min/1.73m\^2 within 14 days prior to randomization or on dialysis or expected to be started on dialysis within the next 12 weeks starting from randomization 5. Has any other condition or therapy which would make the participant unsuitable for this study or not allow participation for the full planned study period 6. Has allergy, hypersensitivity, or other contraindication to REGN7508, REGN9933, or rivaroxaban (Cohort 2 only) or their excipients Note: Other Protocol Defined Inclusion/ Exclusion Criteria Apply

Primary outcome measure(s)

  • Time-to-first occurrence of a major thrombotic vascular event, consisting of Acute Limb Ischemia (ALI), major amputation (above the ankle) of vascular etiology, Myocardial Infarction (MI), ischemic stroke, or Cardiovascular (CV) death — Approximately up to 42 months
    Cohort 1
  • Time-to-first occurrence of International Society of Thrombosis and Hemostasis (ISTH) major or Clinically Relevant Non-major (CRNM) bleeding — Approximately up to 42 months
    Cohort 1 and 2

Trial sites (29)

FacilityCityRegionStatus
Advanced Cardiovascular Alexander City Alabama Recruiting
Lake Martin Medical and Vascular Center Alexander City Alabama Recruiting
Axsendo Clinical Research, Integrated Medical Services Avondale Arizona Recruiting
Applied Research Center of Arkansas Little Rock Arkansas Recruiting
Angel City Research, Inc. Los Angeles California Recruiting
Pacific Cardiovascular and Vein Institute Oxnard California Recruiting
Interventional Cardiology Medical Group West Hills California Recruiting
Nature Coast Clinical Research - Cardiology Crystal River Florida Recruiting
Cardiovascular Institute of Northwest Florida, Main Office Panama City Florida Recruiting
Tampa Cardiovascular Interventions and Research Tampa Florida Recruiting
Lutheran Medical Group LLC dba Lutheran Health Physicians Fort Wayne Indiana Recruiting
ASHA Clinical Research Munster, LLC Hammond Indiana Recruiting
Profound Research, Powers Health Medical Group Munster Indiana Recruiting
Cardiovascular Solutions Shreveport Louisiana Recruiting
Rovia Clinical Research - Hattiesburg Clinic Petal Mississippi Recruiting
Advanced Heart and Vascular Institute of Hunterdon Flemington New Jersey Recruiting
Mecklenburg Heart Specialists Vascular Institute and Vein Center Charlotte North Carolina Recruiting
Accellacare of Piedmont, Piedmont Healthcare Mooresville North Carolina Recruiting
Hightower Clinical Oklahoma City Oklahoma Recruiting
Monument Health Clinical Research Rapid City South Dakota Recruiting
Apex Research Foundation, LLC Jackson Tennessee Recruiting
Tennova TCMC Knoxville Tennessee Recruiting
Vanderbilt Heart and Vascular Tullahoma, Cardiology and Vascular Associates Tullahoma Tennessee Recruiting
PharmaTex Research Amarillo Texas Recruiting
Vital Heart and Vein Cypress Texas Recruiting
Epic Medical Research DeSoto Texas Recruiting
Epic Medical Research-Plano Plano Texas Recruiting
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust Doncaster United Kingdom Recruiting
Charing Cross Hospital London United Kingdom Recruiting

On this site

📄 Xarelto (rivaroxaban) drug profile →

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Other trials for the same condition

Serranator POINT FORCE Registry Recruiting
The Chocolate Touch Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07318610 on ClinicalTrials.gov ↗ ← All trials in the USA