Effect of Anticoagulant and Antiplatelet Drug Intervention on Postoperative Major Adverse Events in Patients with PAD：Phase II

Launched by CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Feb 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of different blood-thinning medications on patients with Peripheral Arterial Disease (PAD) after they have heart-related procedures. The goal is to see how these medications can help prevent serious complications, such as heart attacks and limb problems, in patients who have undergone specific treatments for their PAD. The study plans to include around 6,000 patients from early 2025 to early 2028, with follow-up evaluations taking place at one month, six months, and twelve months after their procedures.

To be eligible for this trial, participants must have a history of PAD or related symptoms, and they should have recently undergone treatment for their condition. Those interested must also provide their consent to participate. However, individuals with a recent history of strokes, severe heart issues, or certain other health conditions may not be able to join. Participants can expect to take part in regular check-ins to monitor their health and track any major complications that may arise following their treatment. This research aims to improve care and outcomes for patients with PAD, making it an important study for those affected by this condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. History of PAD, or a history of intermittent claudication with an ankle/brachial blood pressure ratio \< 0.9, or angiography-confirmed significant peripheral arterial stenosis (≥50%).
• • 2. Underwent endovascular treatment for aortoiliac, femoral, popliteal, or infrapopliteal arteries.
• • 3. No restrictions on endovascular treatment methods, including all internationally recognized devices and techniques used in real-world practice.
• • 4. Agreed and signed the informed consent form.
• Exclusion Criteria:
• • 1. \*\*Patients with a history of stroke within the past month\*\* or a history of hemorrhagic or lacunar stroke.
• • 2. Patients with a known ejection fraction \< 30% or severe heart failure with Class III/IV symptoms.
• • 3. Patients with non-cardiovascular diseases associated with poor prognosis(e.g., metastatic cancer) or interventions that increase the risk of adverse events in the study.
• • 4. Patients with a history of allergies or known contraindications to drugs such as rivaroxaban or aspirin.
• • 5. Patients with any known liver disease associated with coagulation disorders. 6. Pregnant or breastfeeding women, or women of childbearing potential who are sexually active and not using effective contraception.
• • 7. Patients with known contraindications to any study-related procedures.