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

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

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 Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Anticoagulant Drugs; Antiplatelet Drug
• Intervention / Treatment: Drug: anticoagulant or antiplatelet drugs

• Study Type: Observational
• Enrollment (Anticipated): 6000

Contacts and Locations

Study Locations

• China
  • None Selected
    • Hangzhou, None Selected, China, 310003
      • Recruiting
      • First affiliated Hospital of Zhejiang University
      • Contact: Ziheng Wu; Phone Number: 13757150163; Email: wuziheng@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Intracavitary therapy for lower extremity arteriosclerosis obliterans

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: April 22, 2023
• First Submitted That Met QC Criteria: May 8, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases; Anticoagulants; Platelet Aggregation Inhibitors
• Other Study ID Numbers: IIT20230084B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: With the consent of the committee, it can be based on patient data
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No