NCT07076082 · Corewell Health West
Vascular Trial Associated Registry Pilot
(VSTAR-P)
What this study is about
The purpose of this investigator-initiated, conducted at multiple hospitals, open label, randomly assigned trial is to evaluate 1 month vs. 6 months of dual antiplatelet therapy (DAPT) in patients undergoing lower extremity endovascular revascularization.
View original scientific description
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.
Interventions
DRUG
Clopidogrel (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).
Primary outcome measures
The proportion of patients eligible who are offered study enrollment
Time frame: 1 year
Patients who undergo PVI that meet inclusion criteria and are offered enrollment.
The proportion of eligible patients who consent to enrollment and randomization
Time frame: 1 year
Patients who meet inclusion criteria and agree to participate in trial vs those that do not agree to participate in trial
The proportion of enrolled patients who have the primary (composite) event of interest defined at 6 months
Time frame: 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.
The proportion of enrolled patients who have the primary (composite) event of interest defined at 12 months
Time frame: 1 year
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.
The numbers and proportions of patients who have each type of major event
Time frame: 1 year
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.
The proportions of patients who have major event status recorded at each observation time
Time frame: 1 year
Major event status at 1, 6-months post PVI and 12-month post PVI
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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
Where
- Detroit, Michigan
- Grand Rapids, Michigan
Collaborators
Henry Ford Hospital
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 16, 2026 · Source of record for eligibility and locations