Effect of Anticoagulant Drug Intervention on Postoperative MALE and MACE in Patients With PAD

Recruiting

• Conditions: Anticoagulant Drugs; Antiplatelet Drug; Peripheral Arterial Disease
• Interventions: Drug: anticoagulant or antiplatelet drugs

• Registration Number: NCT05852197
• Lead Sponsor: First Affiliated Hospital of Zhejiang University

Brief Summary

Patients with PAD were grouped according to the combination of different anticoagulant and antiplate drugs. The type, dosage and duration of anticoagulant and antiplatelet drugs were recorded after operation. Major Adverse Cardiovascular Events and Major Adverse Limb Events were followed up at 1 month, 6 months and 12 months, respectively.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-02
• Study First Submitted: 2023-04-22
• Study First Submitted QC: 2023-05-08
• Last Update Submitted: 2023-05-08
• Study First Posted: 2023-05-10
• Last Update Posted: 2023-05-10
• Primary Completion: 2024-02-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 6000

Inclusion Criteria

1. Age ≥50 years old
2. Patients with symptomatic PAD
3. Moderate intermittent claudication, or severe limb ischemia
4. Radiographically confirmed occlusion
5. Received a successful revascularization

Exclusion Criteria

1. Acute limb ischemia occurred within 2 weeks before revascularization;
2. Large tissue defect of any lower limb (defined as obvious ulceration/gangrene near phalangeal head);
3. After revascularization, there are clinical conditions requiring systemic anticoagulation

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Use a combination of anticoagulant or antiplatelet drugs ， group 1	anticoagulant or antiplatelet drugs	-
Use a combination of anticoagulant or antiplatelet drugs， group 2	anticoagulant or antiplatelet drugs	-

Primary Outcome Measures

Name	Time	Method
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease	The 12th month after treatment	The incidence of myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.

Secondary Outcome Measures

Name	Time	Method
all-cause mortality	The 1st，3rd，6th，9th，12th month	Deaths occurring during follow-up, regardless of cause
MALE	The 1st，3rd，6th，9th，12th month	The incidence of acute limb ischemia, major amputation due to vascular disease owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
MACE	The 1st，3rd，6th，9th，12th month	The incidence of myocardial infarction, ischemic stroke owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month.
health economics evaluation	The 1st，3rd，6th，9th，12th month	The cost of patient treatment
Compound protection from vasogenic adverse events	The 1st，3rd，6th，9th，12th month	The incidence of muscle infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease, massive bleeding after the treatment. Measured in the first, sixth, ninth, and twelfth month.

Trial Locations

Locations (1)

First Affiliated Hospital of Zhejiang University; 🇨🇳 Hangzhou, None Selected, China