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Recruiting Phase 4 NCT07076082

Vascular Trial Associated Registry Pilot

Trial Parameters

Condition Peripheral Arterial Disease
Sponsor Corewell Health West
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 350
Sex ALL
Min Age 45 Years
Max Age N/A
Start Date 2025-10-15
Completion 2027-10-30
Interventions
Clopidogrel (Plavix) Pharmacogenetic Test Reagents

Brief 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 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 warfar

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