NCT05852197RecruitingNot Applicable
Effect of Anticoagulant Drug Intervention on postoperativeMajor Adverse Limb Events and Major Adverse Cardiovascular Events in Patients With Peripheral Arterial Disease
First Affiliated Hospital of Zhejiang University1 site in 1 country6,000 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 6,000
- Locations
- 1
- Primary Endpoint
- Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age ≥50 years old
- •Patients with symptomatic PAD
- •Moderate intermittent claudication, or severe limb ischemia
- •Radiographically confirmed occlusion
- •Received a successful revascularization
Exclusion Criteria
- •Acute limb ischemia occurred within 2 weeks before revascularization;
- •Large tissue defect of any lower limb (defined as obvious ulceration/gangrene near phalangeal head);
- •After revascularization, there are clinical conditions requiring systemic anticoagulation
Arms & Interventions
Use a combination of anticoagulant or antiplatelet drugs ， group 1
Intervention: anticoagulant or antiplatelet drugs (Drug)
Use a combination of anticoagulant or antiplatelet drugs， group 2
Intervention: anticoagulant or antiplatelet drugs (Drug)
Outcomes
Primary Outcomes
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
Time Frame: 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 Outcomes
- all-cause mortality(The 1st，3rd，6th，9th，12th month)
- MALE(The 1st，3rd，6th，9th，12th month)
- MACE(The 1st，3rd，6th，9th，12th month)
- health economics evaluation(The 1st，3rd，6th，9th，12th month)
- Compound protection from vasogenic adverse events(The 1st，3rd，6th，9th，12th month)
Investigators
Study Sites (1)
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