Vascular Trial Associated Registry Pilot: Antiplatelet Therapies for Patients Undergoing Lower Extremity Endovascular Revascularization
Corewell Health West
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.
Description
The Main Objective of this study is to create an investigator-initiated, multicenter, open label, randomized trial to evaluate 1 month vs. 6 months of DAPT in patients undergoing lower extremity endovascular revascularization. The randomization will be 1:1 within one strata (diabetes yes/no), using blocks of varying sizes. All patients will be on DAPT for one month. At the time of the one-month visit, eligible patients who consent will be randomized to single antiplatelet therapy (SAPT) indefinitely (Arm 1) or to DAPT for 5 more months (followed by SAPT) (Arm 2). Follow-up will continue for 12…
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- No
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…
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).
Locations (2)
- Henry Ford HospitalDetroit, Michigan
- Corewell Health WestGrand Rapids, Michigan