Peripheral Arterial Disease study: Clopidogrel
Official title Vascular Trial Associated Registry Pilot
ClinicalTrials.gov ID: NCT07076082
What this study is testing
What is Clopidogrel (Plavix) Pharmacogenetic Test Reagents?
This is an investigational test being studied to help guide treatment choices for people with peripheral arterial disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a longer course of two blood‑thinning medicines keeps the treated artery open after a leg procedure. It also checks if the longer course causes more bleeding.
- Who it's for
- You may be able to join if you had a lower leg artery procedure and are healthy enough to take medicines for up to six months.
- What's involved
- You will take two medicines that help blood not clot, starting right after your procedure. You will have check‑ups at the clinic to see how your artery is doing and to watch for side effects.
- Time commitment
- The study lasts up to six months, with visits at the start, one month, and six months after the procedure.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility 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
- 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
- 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
- Prisoners
The study team makes the final eligibility decision.
Where it is enrolling
- Detroit, Michigan, United States
- Grand Rapids, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Detroit, Michigan, United States; Grand Rapids, Michigan, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.