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

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.

Official Title
-----------------
Effect of Anticoagulant Drug Intervention on postoperativeMajor Adverse Limb Events and Major Adverse Cardiovascular Events in Patients With Peripheral Arterial Disease

Conditions
-----------------
Anticoagulant Drugs, Antiplatelet Drug, Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Drug: anticoagulant or antiplatelet drugs


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Use a combination of anticoagulant or antiplatelet drugs ， group 1<br> | Drug: anticoagulant or antiplatelet drugs<br>* combination of anticoagulant or antiplatelet drugs<br>|
| Use a combination of anticoagulant or antiplatelet drugs， group 2<br> | Drug: anticoagulant or antiplatelet drugs<br>* combination of anticoagulant or antiplatelet drugs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | The 12th month after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE | The incidence of myocardial infarction, ischemic stroke owing to vascular disease after the treatment. Measured in the first, sixth, ninth, and twelfth month. | The 1st，3rd，6th，9th，12th month | 
| MALE | 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. | The 1st，3rd，6th，9th，12th month | 
| Compound protection from vasogenic adverse events | 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. | The 1st，3rd，6th，9th，12th month | 
| all-cause mortality | Deaths occurring during follow-up, regardless of cause | The 1st，3rd，6th，9th，12th month | 
| health economics evaluation | The cost of patient treatment | The 1st，3rd，6th，9th，12th month |