Peripheral artery stenosis 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 investigating whether combining two blood-thinning medications is more effective than using one medication alone in preventing serious health complications in people with peripheral arterial disease who have had procedures to open blocked arteries in their legs.

Main inclusion criteria:

• Patients must be 45 years of age or older
• Must have blockages in the iliac, femoropopliteal, or below-the-knee arteries (specific areas in the legs where blood flow is reduced)
• Must have at least one TASC lesion, a specific type of arterial blockage
• Must fall into Rutherford classes 1-6, which describe the severity of symptoms ranging from mild to severe
• The blockages must be suitable for treatment with percutaneous transluminal angioplasty (a procedure to widen narrowed arteries), with or without stent placement, hybrid procedures combining surgery and other interventions, or planned reintervention within 2 months
• Must be able to understand the study requirements and provide written informed consent

Main exclusion criteria:

• Patients with other serious health conditions that could interfere with the study
• Recent heart attack or stroke
• Severe liver or kidney disease
• Patients who are pregnant or breastfeeding
• Known allergy to the study medications
• History of bleeding disorders
• Recent major surgery
• Uncontrolled high blood pressure
• Currently participating in another clinical trial
• Unable to follow study procedures or attend follow-up visits

Trial focus and goals:

The study aims to determine whether dual antiplatelet therapy (using both clopidogrel and acetylsalicylic acid together) is more effective than single antiplatelet therapy (using clopidogrel alone) in reducing serious health events after endovascular revascularization procedures. The trial will monitor participants for up to 12 months to track occurrences of death from any cause, major cardiovascular events such as heart attacks or strokes, and major limb events including re-intervention or amputation. Researchers will also carefully monitor for bleeding events and other side effects to assess the safety of these treatment approaches.

Investigational drugs:

The trial uses two medications that help prevent blood clots:

• Clopidogrel (75 mg tablet taken daily) – This medication makes the blood less sticky by blocking specific receptors on platelets, which helps prevent harmful blood clots that could lead to heart attacks or strokes
• Acetylsalicylic Acid, commonly known as aspirin (80 mg tablet taken daily) – This medication works by blocking an enzyme that promotes platelet clumping, thereby reducing the formation of blood clots

Participants will be randomly assigned to receive either clopidogrel alone or both medications together, with treatment continuing throughout the one-year study period. The combination of these medications is designed to provide enhanced protection against cardiovascular complications in patients who have undergone procedures to restore blood flow in their leg arteries.