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.
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-months post-procedure and will include assessment of MACE and MALE, as well as adverse bleeding events. Data for this trial will be collected via nested participation in the VQI Peripheral Vascular Intervention (PVI) registry's existing Procedural and Follow-up data collection modules.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
350
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).
Henry Ford Hospital
Detroit, Michigan, United States
NOT_YET_RECRUITINGCorewell Health West
Grand Rapids, Michigan, United States
RECRUITINGThe proportion of patients eligible who are offered study enrollment
Patients who undergo PVI that meet inclusion criteria and are offered enrollment.
Time frame: 1 year
The proportion of eligible patients who consent to enrollment and randomization
Patients who meet inclusion criteria and agree to participate in trial vs those that do not agree to participate in trial
Time frame: 1 year
The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months
The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
Time frame: 6-months
The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months
The number of enrolled patients that have the occurrence of one of the following stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
Time frame: 1 year
The numbers and proportions of patients who have each type of major event
Of the enrolled patients that have a medical primary event how many individuals were in each category stroke, myocardial infarction, major amputation (above ankle), urgent revascularization (thrombolysis, endovascular therapy, or surgical bypass), or loss of patency of the target vessel.
Time frame: 1 year
The proportions of patients who have major event status recorded at each observation time
Major event status at 1, 6-months post PVI and 12-month post PVI
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Time frame: 1 year