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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChengdu University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%).

Disqualifiers

1. **Patients with a history of stroke within the past month** or a history of hemorrhagic or lacunar stroke.

Trial population

Patients undergoing endovascular treatment for lower extremity arteriosclerosis obliterans

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

Composite Adverse Event Rate (MACE/MALE): Myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation due to vascular disease.

MACE (Major Adverse Cardiovascular Events): Includes acute myocardial infarction, severe arrhythmia, heart failure, ischemic stroke, and death. Follow-up and recording will be conducted at 1 month, 6 months, and 12 months postoperatively. MALE (Major Adverse Limb Events): Includes major amputation, bleeding events (such as cerebral hemorrhage and gastrointestinal bleeding), and reintervention of the ipsilateral lower limb artery. Assessments will be performed at 1 month, 6 months, and 12 months postoperatively.

Time frame
From enrollment to the end of treatment at 12 months

Secondary outcomes

1

MACE(Major Adverse Cardiovascular Events)

MACE (Major Adverse Cardiovascular Events): Includes acute myocardial infarction, severe arrhythmia, heart failure, ischemic stroke, and death. Follow-up and recording will be conducted at 1 month, 6 months, and 12 months postoperatively

Time frame
From enrollment to the end of treatment at 12 months

Other outcomes

1

MALE(Major Adverse Limb Events)

MALE (Major Adverse Limb Events): Includes major amputation, bleeding events (such as cerebral hemorrhage and gastrointestinal bleeding), and reintervention of the ipsilateral lower limb artery. Assessments will be performed at 1 month, 6 months, and 12 months postoperatively.

Time frame
From enrollment to the end of treatment at 12 months
2

Composite Freedom from Vascular Adverse Events

Composite Freedom from Vascular Adverse Events refers to the absence of any of the aforementioned events (MACE, MALE, or major bleeding) during the follow-up period.

Time frame
From enrollment to the end of treatment at 12 months
3

All-Cause Mortality

All-cause mortality refers to death from any cause.

Time frame
From enrollment to the end of treatment at 12 months

Locations

This trial has no locations.

Sponsors and contacts

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