Peripheral artery restenosis 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 trial is being conducted in the Netherlands and focuses on comparing two treatment approaches for patients with peripheral arterial disease who have undergone procedures to open blocked blood vessels in their legs.

Who can participate:

• Patients aged 45 years or older
• Those with blockages in specific leg arteries (iliac, femoropopliteal, or below-the-knee arteries)
• Patients who have undergone or will undergo procedures such as angioplasty (a balloon procedure to open arteries), with or without stents, or hybrid procedures combining surgery with other interventions
• Patients classified in Rutherford classes 1-6, which indicate varying degrees of symptom severity
• Those who can understand the study requirements and provide written consent

Who cannot participate:

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

What the trial involves:

The main goal is to determine whether using two blood-thinning medications together is more effective than using just one in preventing serious health problems after artery-opening procedures. The trial compares single antiplatelet therapy using clopidogrel alone against dual antiplatelet therapy using both clopidogrel and acetylsalicylic acid (aspirin). Some participants will receive a placebo, which looks like medication but contains no active ingredients.

Participants take their assigned treatment daily as tablets for up to 12 months. Throughout this period, doctors monitor for serious events such as death, heart attacks, strokes, need for repeat procedures, or amputations. The study also tracks bleeding events and other side effects.

Investigational drugs:

Clopidogrel is a medication that makes blood less sticky, helping prevent harmful clots that can lead to heart attacks or strokes. It is given as a 75 mg tablet taken by mouth daily. Clopidogrel works by blocking specific receptors on platelets, preventing them from clumping together.

Acetylsalicylic acid (aspirin) is commonly used to reduce pain and inflammation, but in this trial it helps prevent blood clots. It is given as an 80 mg tablet taken by mouth daily. Aspirin works by blocking an enzyme that promotes platelet clumping, thereby reducing the risk of clot formation.