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

N/AUnknownNCT05852197

First Affiliated Hospital of Zhejiang University6,000 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

6,000

Conditions

Anticoagulant Drugs Antiplatelet Drug Peripheral Arterial Disease

Interventions

anticoagulant or antiplatelet drugsDRUG

combination of anticoagulant or antiplatelet drugs

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, None Selected, China

RECRUITING

Outcomes

Primary Outcomes

Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease

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.

Time frame: The 1st month after treatment

Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease

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.

Time frame: The 3rd month after treatment

Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease

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.

Time frame: The 6th month after treatment

Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease

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.

Time frame: The 9th month after treatment

Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease

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.

Data from ClinicalTrials.gov

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