Recruiting PHASE4 Peripheral Arterial Disease

New treatment option for Peripheral Arterial Disease

Official title Vascular Trial Associated Registry Pilot

ClinicalTrials.gov ID: NCT07076082

What this study is testing

What is Clopidogrel (Plavix) Pharmacogenetic Test Reagents?

Clopidogrel (Plavix) Pharmacogenetic Test Reagents is an investigational medicine, being studied as a potential treatment for 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
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.
  • 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
Who can join
  • 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
What rules you out
  • 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
  • Prisoners

The study team makes the final eligibility decision.

Where it's taking place

  • 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 - 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?

Study sites include Detroit, Michigan, United States; Grand Rapids, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.