Peripheral artery angioplasty Trials in Disease

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

This clinical trial is being conducted in the Netherlands and focuses on patients with Peripheral Arterial Disease, a condition where narrowed blood vessels in the legs reduce blood flow. The study compares two treatment approaches: using clopidogrel alone versus using both clopidogrel and acetylsalicylic acid (commonly known as aspirin) together.

Who can participate:

• Patients who are 45 years old or older
• Patients with blockages in specific leg arteries, including the iliac, femoropopliteal, or below-the-knee arteries
• Patients with at least one TASC lesion, which is a particular type of arterial blockage
• Patients classified in Rutherford classes 1-6, which describe different levels of symptom severity
• Patients whose blockages can be treated with procedures such as percutaneous transluminal angioplasty (a procedure to open blocked arteries), with or without a stent, or hybrid procedures combining surgery and other interventions
• Patients who understand the study requirements and provide written consent to participate

Who cannot participate:

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

What the trial investigates:

The main goal of this study is to determine whether dual antiplatelet therapy, using both clopidogrel and acetylsalicylic acid together, is more effective than single therapy with clopidogrel alone in preventing serious cardiovascular events. These events include death from any cause, heart attacks, strokes, need for repeat procedures to restore blood flow, and major limb complications such as amputation. The study will also monitor for bleeding events and other side effects.

Investigational medications:

The trial uses two medications that help prevent blood clots. Clopidogrel is given as a 75 mg tablet taken by mouth daily. It works by making the blood less sticky, reducing the formation of harmful clots that can lead to heart attacks or strokes. Acetylsalicylic acid, commonly known as aspirin, is given as an 80 mg tablet taken by mouth daily. It works by blocking an enzyme that promotes blood clotting. When used together, these medications provide dual antiplatelet therapy, which may offer better protection against cardiovascular complications than using clopidogrel alone.

Participants will be randomly assigned to receive either single therapy with clopidogrel or dual therapy with both medications, and will take their assigned treatment daily for up to 12 months. Throughout the study, their health will be carefully monitored through regular follow-up assessments to track any serious health events or complications.