Clinical trial
Effect of Anticoagulant Drug Intervention on postoperativeMajor Adverse Limb Events and Major Adverse Cardiovascular Events in Patients With Peripheral Arterial Disease
Name
IIT20230084B
Description
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.
Trial arms
Trial start
2023-01-01
Estimated PCD
2024-02-01
Trial end
2026-01-01
Status
Recruiting
Treatment
anticoagulant or antiplatelet drugs
combination of anticoagulant or antiplatelet drugs
Arms:
Use a combination of anticoagulant or antiplatelet drugs ， group 1, Use a combination of anticoagulant or antiplatelet drugs， group 2
Size
6000
Primary endpoint
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
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 3rd month after treatment
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
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 9th month after treatment
Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
The 12th month after treatment
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 6000, 'type': 'ESTIMATED'}}
Updated at
2023-05-10
1 organization
1 product
3 indications
Organization
First Affiliated Hospital of Zhejiang UniversityIndication
Anticoagulant DrugsIndication
antiplatelet therapyIndication
Peripheric Vascular Enfermedad