Effect of Anticoagulant and Antiplatelet Drug Intervention on Postoperative Major Adverse Events … (NCT06850207) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Effect of Anticoagulant and Antiplatelet Drug Intervention on Postoperative Major Adverse Events in Patients with PAD:Phase II
6,000 participantsStarted 2025-02-28
Plain-language summary
This study is a multicenter, prospective, observational research project. It is anticipated to enroll a total of 6,000 patients between February 1, 2025, and January 31, 2028 (with completion of one-year postoperative follow-up by January 31, 2029). Patients will be grouped according to different combinations of anticoagulant and antiplatelet drugs used postoperatively for PAD. The types, dosages, and duration of postoperative anticoagulant and antiplatelet drug use will be recorded. Follow-up assessments will be conducted at 1 month, 6 months, and 12 months postoperatively to document the occurrence of Major Adverse Cardiovascular Events (MACE) and Major Adverse Limb Events (MALE) in the enrolled patients.
Who can participate
SexALL
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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.
What they're measuring
1
Composite Adverse Event Rate (MACE/MALE): Myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation due to vascular disease.
Timeframe: From enrollment to the end of treatment at 12 months
Trial details
NCT IDNCT06850207
SponsorChengdu University of Traditional Chinese Medicine