Vascular Trial Associated Registry Pilot
ConditionPeripheral Arterial Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age45+
SponsorCorewell Health West
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Clopidogrel (Plavix) Pharmacogenetic Test Reagents
DrugDual 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).
Treatment groups
350 Participants
are divided into 2 treatment groupsGroup A: Dual antiplatelet therapy 1-Month followed by single antiplatelet therapy indefinitelyActive comparator 1 intervention
Group B: Dual antiplatelet therapy 6-Month followed by single antiplatelet therapy indefinitelyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
The proportion of patients eligible who are offered study enrollment
Patients who undergo PVI that meet inclusion criteria and are offered enrollment.
Time frame
1 year2
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 year3
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-months4
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 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Corewell Health West
Lead sponsor
Henry Ford Hospital
Collaborator
Source ClinicalTrials.gov