Vascular registry pilot for peripheral arterial disease

Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization

Trying whether taking two antiplatelet medicines for six months instead of one month helps keep treated leg arteries open after lower extremity endovascular revascularization in people with peripheral arterial disease.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 350 (estimated)
• Ages: 45 Years and up
• Sex: All
• Sponsor: Corewell Health West (Academic / other)
• Locations: 2 sites (Detroit, Michigan and 1 other locations)
• Trial ID: NCT07076082 on ClinicalTrials.gov

What this trial studies

This multicenter, open-label randomized pilot enrolls patients aged 45 and older undergoing lower extremity endovascular revascularization for atherosclerotic peripheral arterial disease. All participants receive dual antiplatelet therapy (aspirin plus clopidogrel) for the first month, and those who consent at one month are randomized 1:1 (stratified by diabetes) to stop clopidogrel and continue single antiplatelet therapy versus continue dual therapy for an additional five months. Outcomes including target vessel patency, major adverse cardiovascular events (MACE), major adverse limb events (MALE), and bleeding events are followed for 12 months and data are collected through nested participation in the VQI-PVI registry.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 or older with atherosclerotic peripheral arterial disease who undergo lower extremity endovascular revascularization, can consent, are not allergic to aspirin or clopidogrel, and can participate in VQI-PVI registry data submission and follow-up.

Not a fit: Patients at high bleeding risk, those allergic to aspirin or clopidogrel, those unable to stop anticoagulants or on dual pathway inhibition, or those with nonatherosclerotic vascular disease are unlikely to benefit from extended dual antiplatelet therapy in this protocol.

Why it matters

Potential benefit: If successful, extending dual antiplatelet therapy could increase the chance that treated leg arteries remain open without substantially increasing bleeding complications.

How similar studies have performed: Longer dual antiplatelet regimens have shown mixed results in peripheral interventions and more consistent evidence in coronary stenting, so this approach is plausible but not yet well established for peripheral arterial disease.

Eligibility criteria

Inclusion Criteria:

* Age greater than or equal to 45 at time of enrollment
* Patient is scheduled for a PVI or has recently had a PVI in the last 30 days
* Patient data is being submitted to Fivos, who is acting as the data collection subcontractor for the VQI-PVI registry.
* Atherosclerotic vascular disease

Exclusion Criteria:

* Patients who cannot consent for themselves
* Allergy to Clopidogrel
* Patients unable to stop clopidogrel for other medical reasons
* Patients on dual pathway inhibition (DPI) with low dose rivaroxaban (2.5mg twice a day) that are unable to stop these medications
* Allergy to aspirin
* Nonatherosclerotic vascular disease
* Patients undergoing open bypass at the same time as the peripheral transcutaneous angioplasty
* Patients with high bleeding risk (HBR) defined as:

  * History of major bleeding, active bleeding disorder, severe renal impairment (CrCl \<30), concurrent anticoagulation, platelet count \<100,000
  * Recent stroke (within 6 months)
  * Current warfarin therapy or full dose therapeutic direct oral anticoagulants (DOAC).
* Patients unwilling or unable to comply with standard of care follow-up visits
* Pregnant women
* Prisoners

Where this trial is running

Detroit, Michigan and 1 other locations

• Henry Ford Hospital — Detroit, Michigan, United States (Not_yet_recruiting)
• Corewell Health West — Grand Rapids, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Vikram C Kashyap, MD — Corewell Health West
• Study coordinator: Stephen C Orey, MS

Conditions Peripheral Arterial Disease; Peripheral Vascular Disease, Peripheral Vascular Intervention, Dual Antiplatelet therapy, Peripheral Arterial Disease