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

NCT06850207 | Not Yet Recruiting

• 1 other identifier: ChengduUTCM11
• Study Type: observational
• Target: 6,000
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Peripheral Arterial Disease(PAD)

Keywords

peripheral arterial disease; Anticoagulant and Antiplatelet Drug; Adverse Events

Outcome Measures

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.

  From enrollment to the end of treatment at 12 months

Secondary Outcomes (1)

• MACE（Major Adverse Cardiovascular Events）

  From enrollment to the end of treatment at 12 months

Other Outcomes (3)

• MALE（Major Adverse Limb Events）

  From enrollment to the end of treatment at 12 months

• Composite Freedom from Vascular Adverse Events

  From enrollment to the end of treatment at 12 months

• All-Cause Mortality

  From enrollment to the end of treatment at 12 months

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing endovascular treatment for lower extremity arteriosclerosis obliterans

You may qualify if:

• \. 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%).
• \. Underwent endovascular treatment for aortoiliac, femoral, popliteal, or infrapopliteal arteries.
• \. No restrictions on endovascular treatment methods, including all internationally recognized devices and techniques used in real-world practice.
• \. Agreed and signed the informed consent form.

You may not qualify if:

• \. \*\*Patients with a history of stroke within the past month\*\* or a history of hemorrhagic or lacunar stroke.
• \. Patients with a known ejection fraction \< 30% or severe heart failure with Class III/IV symptoms.
• \. 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.
• \. Patients with a history of allergies or known contraindications to drugs such as rivaroxaban or aspirin.
• \. 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.
• \. Patients with known contraindications to any study-related procedures.

Sponsors & Collaborators

• Chengdu University of Traditional Chinese Medicine: lead

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Central Study Contacts

QIqi Wang

CONTACT

086-15184495605; wangqiqi_czyfy@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: February 23, 2025
• First Posted: February 27, 2025
• Study Start: February 28, 2025
• Primary Completion (Estimated): January 31, 2029
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share