Reducing blood clots after leg artery procedures with Factor XI inhibitors in adults with PAD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial compares REGN7508 and REGN9933 with rivaroxaban and placebo in adults who have peripheral artery disease and recently undergone lower extremity revascularization. The study aims to prevent major thrombotic vascular events and to compare safety profiles, drug levels over time, and antibody formation against the drugs. Participants must have high risk features for thrombosis and have recently had revascularization procedures. Outcomes include adverse events, pharmacokinetics, and immunogenicity in addition to thrombotic and bleeding events.

Why it matters

Who can join: the full rules

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

Where it's running

• Advanced Cardiovascular
  Alexander City, Alabama, United States Recruiting
• Lake Martin Medical and Vascular Center
  Alexander City, Alabama, United States Recruiting
• Axsendo Clinical Research, Integrated Medical Services
  Avondale, Arizona, United States Recruiting
• Applied Research Center of Arkansas
  Little Rock, Arkansas, United States Recruiting
• Angel City Research, Inc.
  Los Angeles, California, United States Recruiting
• Pacific Cardiovascular and Vein Institute
  Oxnard, California, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.