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 study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Stichting OLVG Amsterdam The Netherlands
Zuyderland Medisch Centrum Stichting Geleen The Netherlands

Other Sites

Site Name City Country Status
Haga Hospital Hague The Netherlands
Noordwest Ziekenhuisgroep Stichting Alkmaar The Netherlands
Isala Klinieken Stichting Zwolle The Netherlands
Jeroen Bosch Ziekenhuis Stichting s-Hertogenbosch The Netherlands
Tergooiziekenhuizen Hilversum The Netherlands
Medisch Spectrum Twente Enschede The Netherlands
Ziekenhuisgroep Twente Stichting Almelo The Netherlands
Rode Kruis Ziekenhuis B.V. Beverwijk The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Maasstad Ziekenhuis Stichting Rotterdam The Netherlands
St. Antonius Ziekenhuis Nieuwegein The Netherlands
Meander Medical Center Amersfoort The Netherlands
Medical Center Haaglanden Leidschendam The Netherlands
Spaarne Gasthuis Hoofddorp The Netherlands
Rnahgnxxl Zisqbnjvqs Snyizcbhv Arnhem The Netherlands
Swtmqtcwa Mialgis Zyudmsfkij Groningen The Netherlands
Sjo Ektwgidzx Hkiuooqc Tfssyxc Tilburg The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Recruiting
09.07.2024

Trial locations

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.

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 ID:
2024-513363-15-01
Trial Phase:
Human Pharmacology (Phase I) – Other

Other Trials to Consider

  • A study comparing one month versus one year of aspirin and clopidogrel treatment in patients with chronic limb-threatening ischemia after below-the-knee vascular therapy.

    Not yet recruiting

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    Investigated diseases:
    Investigated drugs:
    France