RecruitingPhase 4NCT07076082

Vascular Trial Associated Registry Pilot

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

Sponsor

Corewell Health West

Enrollment

350 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

Peripheral Arterial Disease

Summary

The purpose of this investigator-initiated, multicenter, open label, randomized trial is to evaluate 1 month vs. 6 months of dual antiplatelet therapy (DAPT) in patients undergoing lower extremity endovascular revascularization. We hypothesize that extending dual antiplatelet therapy (DAPT) to six months, compared to one month, will improve patency rates of target vessels following peripheral vascular intervention (PVI) without significantly increasing complications, particularly bleeding events.

Eligibility

Min Age: 45 Years

Inclusion Criteria4

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 Criteria14

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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGClopidogrel (Plavix) Pharmacogenetic Test Reagents

Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (clopidogrel) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).