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Study on the Effect of Clopidogrel and Acetylsalicylic Acid on Reducing Heart and Blood Vessel Events in Patients with Peripheral Arterial Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of different treatments for Peripheral Arterial Disease (PAD), a condition where the blood vessels in the legs are narrowed, reducing blood flow. The study will compare two types of treatments: single antiplatelet therapy using Clopidogrel and dual antiplatelet therapy using both Clopidogrel and Acetylsalicylic Acid (commonly known as aspirin). These medications help prevent blood clots, which can improve blood flow and reduce the risk of serious complications.

The purpose of the study is to determine if using both medications together is more effective than using just one in reducing the risk of serious health events, such as heart attacks or strokes, in patients with PAD who have undergone a procedure called endovascular revascularization. This procedure is used to open up blocked blood vessels in the legs. Participants in the study will be randomly assigned to receive either the single or dual therapy, or a placebo, which is a tablet that looks like the medication but does not contain any active ingredients.

The study will last for up to 12 months, during which participants will take the assigned treatment orally in the form of tablets. Throughout the study, the health of the participants will be monitored to track any occurrences of serious health events, such as death from any cause, major cardiovascular events, or major limb events. The study will also look at the occurrence of bleeding and other side effects. By the end of the study, researchers hope to better understand the benefits and risks of these treatments for people with PAD.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment

    Upon joining the study, eligibility is confirmed based on specific criteria such as age, medical condition, and understanding of the trial's implications.

    Written informed consent is required to participate.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the condition of the arteries, specifically the iliac, femoropopliteal, and below-the-knee arteries.

    This assessment determines the suitability for procedures like percutaneous transluminal angioplasty or other interventions.

  3. Step 3

    Medication administration

    Participants are randomly assigned to receive either single antiplatelet therapy (SAPT) with clopidogrel or dual antiplatelet therapy (DAPT) with clopidogrel and acetylsalicylic acid.

    Clopidogrel is administered as a 75 mg film-coated tablet taken orally.

    Acetylsalicylic acid is administered as an 80 mg tablet taken orally.

    The medication is taken daily for the duration of the trial.

  4. Step 4

    Follow-up assessments

    Regular follow-up assessments are conducted to monitor the occurrence of any cardiovascular events or complications.

    These assessments help determine the effectiveness of the treatment in reducing adverse events.

  5. Step 5

    End of trial evaluation

    At the end of the one-year follow-up period, a final evaluation is conducted to assess the primary and secondary endpoints.

    The primary endpoint includes all-cause death and cardiovascular events such as re-intervention, amputation, or myocardial infarction.

    The secondary endpoint includes the occurrence of bleeding events and other major adverse cardiovascular and limb events.

Who can join the trial?

9 criteria

  • The patient must have blockages in the **iliac**, **femoropopliteal**, and/or **below-the-knee (BTK)** arteries. These are specific areas in the legs where blood flow can be reduced.
  • The patient must have at least one **TASC lesion**, which is a type of blockage in the arteries.
  • The patient must be in **Rutherford classes 1-6**, which are categories that describe the severity of symptoms in patients with artery disease, and there must be a need for a procedure to open up the arteries.
  • The patient must understand what it means to join the study and what it involves.
  • The patient must provide **written informed consent**, which means they agree in writing to participate after understanding the study details.
  • The patient must be **45 years old or older**.
  • The blockages in the patient's arteries must be suitable for one of the following treatments:
    • **Percutaneous transluminal angioplasty (PTA)** or **recanalization**, which are procedures to open up blocked arteries, with or without placing a small tube called a stent.
    • A **hybrid procedure**, which combines surgery on the common femoral artery with additional procedures on the iliac, femoral, or tibial arteries.
    • A **reintervention** within 2 months, which means another procedure is needed shortly after the first one as part of a planned treatment.

Who cannot join the trial?

10 criteria

  • Patients with other serious health conditions that could interfere with the study.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent heart attack or stroke.
  • Patients with severe liver or kidney disease.
  • Patients who are pregnant or breastfeeding.
  • Patients with a known allergy to the study medication.
  • Patients who have a history of bleeding disorders.
  • Patients who have had recent major surgery.
  • Patients with uncontrolled high blood pressure.
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Investigated drugs

  • Clopidogrel

    is a medication used to prevent blood clots in patients who have undergone certain types of heart or blood vessel procedures. It works by making the blood less sticky, which helps to prevent the formation of harmful clots that can lead to heart attacks or strokes.

  • Acetylsalicylic Acid

    , commonly known as aspirin, is used to reduce pain, fever, or inflammation. In this trial, it is used in combination with clopidogrel to prevent blood clots. This combination is known as dual antiplatelet therapy and is being studied to see if it is more effective than using clopidogrel alone in preventing serious heart and blood vessel problems after certain procedures.

What is already known about the treatment

  • Clopidogrel

    Clopidogrel is administered orally in tablet form and is used to prevent blood clots in patients with cardiovascular conditions. It is currently well-established in medical practice and literature as an antiplatelet medication. The main therapeutic indication for clopidogrel is to reduce the risk of heart attack and stroke in individuals with peripheral arterial disease or other heart-related conditions. At the molecular level, clopidogrel works by inhibiting the P2Y12 component of ADP receptors on the platelet surface, preventing platelet aggregation. It is classified pharmacologically as a platelet aggregation inhibitor.

  • Acetylsalicylic Acid (Aspirin)

    Acetylsalicylic acid, commonly known as aspirin, is taken orally in tablet form and is widely used to reduce pain, fever, and inflammation, as well as to prevent blood clots. It is a well-documented medication in medical literature and is often used in combination with other drugs for enhanced therapeutic effects. The primary therapeutic indication for aspirin in this context is to prevent atherothrombotic events in patients with peripheral arterial disease. Aspirin works by irreversibly inhibiting the enzyme cyclooxygenase, which results in decreased formation of thromboxane A2, a promoter of platelet aggregation. It is classified as a nonsteroidal anti-inflammatory drug (NSAID) and an antiplatelet agent.

Investigated diseases

Peripheral Arterial Disease (PAD) – This condition involves the narrowing or blockage of the arteries, primarily affecting the legs. It occurs when fatty deposits build up in the artery walls, reducing blood flow to the limbs. People with PAD may experience leg pain, especially when walking, which typically eases with rest. As the disease progresses, the pain may occur even at rest, and wounds on the feet or toes may heal slowly. In severe cases, PAD can lead to critical limb ischemia, where blood flow is severely restricted. This can result in tissue damage and may require medical intervention to restore circulation.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-513363-15-01Estimated enrolment1 696 patientsSponsorUniversitair Medisch Centrum Utrecht

sourced from the EU Clinical Trials Register and site verification

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