Effect of Anticoagulant Drug Intervention on Postoperative MALE and MACE in Patients With PAD
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Use a combination of anticoagulant or antiplatelet drugs ， group 1
|
Drug: anticoagulant or antiplatelet drugs
combination of anticoagulant or antiplatelet drugs
|
| Use a combination of anticoagulant or antiplatelet drugs， group 2
|
Drug: anticoagulant or antiplatelet drugs
combination of anticoagulant or antiplatelet drugs
|
Outcome Measures
Primary Outcome Measures
- Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease [The 1st 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.
- Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease [The 3rd 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.
- Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease [The 6th 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.
- Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease [The 9th 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.
- 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
- 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.
- 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.
- 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.
- all-cause mortality [The 1st，3rd，6th，9th，12th month]
Deaths occurring during follow-up, regardless of cause
- health economics evaluation [The 1st，3rd，6th，9th，12th month]
The cost of patient treatment
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Zhejiang University | Hangzhou | None Selected | China | 310003 |
Sponsors and Collaborators
- First Affiliated Hospital of Zhejiang University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IIT20230084B