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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05852197
• Other study ID #: IIT20230084B
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: January 1, 2026

Study information

• Verified date: February 2023
• Source: First Affiliated Hospital of Zhejiang University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6000
• Est. completion date: January 1, 2026
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anticoagulant Drugs
• Antiplatelet Drug
• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Drug:
• anticoagulant or antiplatelet drugs
combination of anticoagulant or antiplatelet drugs

Locations

Country	Name	City	State
China	First Affiliated Hospital of Zhejiang University	Hangzhou	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	all-cause mortality	Deaths occurring during follow-up, regardless of cause	The 1st,3rd,6th,9th,12th month
Secondary	health economics evaluation	The cost of patient treatment	The 1st,3rd,6th,9th,12th month