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
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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