Clopidogrel for Peripheral Artery Disease

(VSTAR-P Trial)

Recruiting at 1 trial location

Overseen By Stephen C Orey, MS

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Spectrum Health Hospitals

Must be taking: Dual antiplatelet

Must not be taking: Warfarin, Full dose DOACs

Disqualifiers: High bleeding risk, Recent stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 6 months

350 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether taking two blood-thinning medicines for six months is more effective than one month for individuals who have undergone a procedure to open blocked leg arteries, known as peripheral vascular intervention. The goal is to determine if extended treatment with Clopidogrel and aspirin keeps the arteries open longer without increasing bleeding risks. Suitable candidates are those aged 45 or older, who have recently had a leg artery procedure, and have artery disease due to plaque buildup. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits a broader range of patients.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop taking certain medications, like clopidogrel and low dose rivaroxaban, if you are unable to stop them for other medical reasons. If you are on warfarin or full dose direct oral anticoagulants, you may also need to stop these medications.

What is the safety track record for Clopidogrel?

Previous studies have shown that clopidogrel is quite safe, especially when compared to aspirin. Research indicates that clopidogrel reduces the risk of major heart-related events more effectively than aspirin. Additionally, clopidogrel is associated with fewer cases of stomach bleeding. For instance, one study found that only 0.7% of people taking clopidogrel experienced gastrointestinal bleeding, compared to 1.1% of those taking aspirin, suggesting that clopidogrel may be gentler on the stomach.

Clopidogrel is a well-known treatment and has already received FDA approval for other uses, which provides some confidence about its safety. Overall, the evidence suggests that clopidogrel is generally well-tolerated and has a lower risk of certain side effects compared to some alternatives. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike the standard care for Peripheral Artery Disease, which typically involves long-term single antiplatelet therapy, this approach is exploring the duration of dual antiplatelet therapy (DAPT) involving Clopidogrel and Aspirin. Researchers are excited because this trial compares two different timeframes for dual therapy—six months vs. one month—before switching to aspirin alone indefinitely. The potential benefit lies in finding the optimal balance between reducing clot-related complications and minimizing bleeding risks, which could lead to more personalized and effective treatment plans.

What evidence suggests that extending dual antiplatelet therapy to six months could be effective for peripheral artery disease?

Research has shown that clopidogrel works well for people with peripheral artery disease (PAD). Studies have found that clopidogrel is more effective than aspirin at lowering the risk of heart problems, such as heart attacks. One study showed that clopidogrel reduced these risks by 23.8% compared to aspirin. Another review found it decreased major heart and blood vessel issues with fewer bleeding problems. In this trial, participants will receive dual antiplatelet therapy with clopidogrel and aspirin for either 1 month or 6 months, followed by aspirin alone indefinitely. Using clopidogrel with aspirin can further lower risks, although some studies found the extra benefit wasn't always significant. Overall, clopidogrel has a strong history of helping people with PAD. ^{3 4 6 7 8}

Who Is on the Research Team?

Vikram C Kashyap, MD

Principal Investigator

Spectrum Health Hospitals

Are You a Good Fit for This Trial?

This trial is for individuals with Peripheral Vascular Disease or Arterial Disease who have undergone a procedure to improve blood flow in their legs. Participants must be suitable for extended medication use, but specific inclusion and exclusion criteria are not detailed here.

Inclusion Criteria

I have been diagnosed with hardening of the arteries.

I am scheduled for or had a pulmonary vein isolation (PVI) within the last 30 days.

Patient data is being submitted to Fivos, who is acting as the data collection subcontractor for the VQI-PVI registry

Exclusion Criteria

Prisoners

Allergy to aspirin

My condition involves blood vessel problems not caused by hardening of the arteries.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive dual antiplatelet therapy (DAPT) for 1 month, followed by randomization to either continue DAPT for 5 more months or switch to single antiplatelet therapy (SAPT) indefinitely

6 months

Monthly visits for monitoring and randomization at 1 month

Follow-up

Participants are monitored for safety and effectiveness, including assessment of MACE, MALE, and adverse bleeding events

12 months

Regular follow-up visits, including assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Clopidogrel

Trial Overview The study tests whether taking two blood-thinning medications (DAPT) for six months offers better outcomes than just one month after leg artery procedures. It's an open-label trial, meaning everyone knows which treatment they receive.

How Is the Trial Designed?

Group I: Dual antiplatelet therapy 6-Month followed by single antiplatelet therapy indefinitely Active Control 1 Intervention

Aspirin and Clopidogrel (Plavix) for 6-months post-procedure followed by Aspirin indefinitely. Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (Plavix) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).

Group II: Dual antiplatelet therapy 1-Month followed by single antiplatelet therapy indefinitely Active Control 1 Intervention

Aspirin and Clopidogrel (Plavix) for 1-month post-procedure followed by Aspirin indefinitely. Dual antiplatelet therapy (DAPT), defined as the use of Clopidogrel (75 mg/day) (Plavix) and aspirin (81 mg or more/day). Single antiplatelet therapy (SAPT), defined as the use of aspirin (81 mg or more/day).

Who Is Running the Clinical Trial?

Spectrum Health Hospitals

Lead Sponsor

Trials

66

Recruited

553,000+

Henry Ford Hospital

Collaborator

Trials

27

Recruited

7,400+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4338727/

Comparative Effectiveness Review of Antiplatelet Agents in ... The PAD subgroup analysis of the CAPRIE RCT suggests that clopidogrel is more effective than aspirin for reducing CV mortality, nonfatal MI, and composite ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCINTERVENTIONS.120.009727

Antiplatelet Therapy Following Peripheral Arterial ... The CAPRIE trial (Clopidogrel Versus Aspirin in Patients at Risk for Ischemic Events), published in 1996, showed a 23.8% relative risk reduction ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa1611688

Ticagrelor versus Clopidogrel in Symptomatic Peripheral ... Clopidogrel monotherapy has been shown to be more effective than aspirin monotherapy in reducing cardiovascular events in a subgroup of patients ...

4. jacc.org jacc.org/doi/10.1016/j.jacc.2018.03.483

Antithrombotic Therapy for Peripheral Artery Disease The primary MACCE endpoint was numerically lower with aspirin plus clopidogrel, but this did not reach statistical significance in the overall trial (6.8% for ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2949912724000606

A review of clopidogrel resistance in lower extremity ... Clopidogrel was initially shown to be more effective than aspirin in reducing MACE with fewer bleeding events in the CAPRIE study. Subsequent meta-analyses have ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8573731/

Efficacy and Safety of Antiplatelet Therapies in Symptomatic ... This updated network meta-analysis confirms that clopidogrel significantly decreases the risk of major adverse cardiovascular events compared with aspirin, ...

7. journals.lww.com journals.lww.com/cardiologyinreview/fulltext/9900/antiplatelet_and_anticoagulation_therapy_for.507.aspx

Antiplatelet and Anticoagulation Therapy for Peripheral... Clopidogrel is preferred, since the CAPRIE trial showed significant risk reduction in the PAD subset of patients over aspirin. Dual pathway ...

8. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)01562-4/abstract

Clopidogrel versus aspirin for secondary prevention of ... Mortality and major bleeding (256 events [0·71 per 100 patient-years] with clopidogrel vs 279 events [0·77 per 100 patient-years] with aspirin; ...