Peripheral artery thrombosis 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 examining whether combining two medications that prevent blood clots is more effective than using just one in patients with peripheral arterial disease who have had a procedure to open blocked blood vessels in their legs.

Main inclusion criteria:

• Patients must be 45 years old or older
• Patients must have blockages in specific arteries of the legs (iliac, femoropopliteal, or below-the-knee arteries)
• Patients must have at least one TASC lesion, which is a type of blockage in the arteries
• Patients must fall into Rutherford classes 1-6, categories that describe the severity of symptoms, and require a procedure to open up the arteries
• The blockages must be suitable for treatment with procedures such as percutaneous transluminal angioplasty (a procedure to open blocked arteries), hybrid procedures (combining surgery with other treatments), or reintervention within 2 months
• Patients must understand the study and provide written informed consent

Main exclusion criteria:

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

Focus and goal of the trial:

The trial aims to determine whether using two antiplatelet medications together (dual antiplatelet therapy) is more effective than using one medication alone (single antiplatelet therapy) in reducing serious health events such as heart attacks, strokes, repeat procedures, or amputations. Participants will be randomly assigned to receive either clopidogrel alone or clopidogrel combined with acetylsalicylic acid (aspirin). The study will last for up to 12 months, during which researchers will monitor participants for cardiovascular events, complications, and side effects such as bleeding.

Investigational drugs:

The trial is testing clopidogrel and acetylsalicylic acid (commonly known as aspirin). Clopidogrel is a medication that makes the blood less sticky, helping to prevent harmful blood clots that can lead to heart attacks or strokes. It is taken orally as a 75 mg tablet once daily. Acetylsalicylic acid is also used to prevent blood clots and is taken as an 80 mg tablet once daily. Together, these medications form what is known as dual antiplatelet therapy. The study will compare this combination treatment against using clopidogrel alone to see which approach is more effective in preventing serious cardiovascular and limb-related events in patients with peripheral arterial disease.