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

NCT05852197 | Unknown FDA Drug

• 1 other identifier: IIT20230084B
• Study Type: observational
• Target: 6,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Anticoagulant Drugs; Antiplatelet Drug; Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• MACE

  The 1st，3rd，6th，9th，12th month

• MALE

  The 1st，3rd，6th，9th，12th month

• Compound protection from vasogenic adverse events

  The 1st，3rd，6th，9th，12th month

• all-cause mortality

  The 1st，3rd，6th，9th，12th month

• health economics evaluation

  The 1st，3rd，6th，9th，12th month

Study Arms (2)

Use a combination of anticoagulant or antiplatelet drugs ， group 1

Drug: anticoagulant or antiplatelet drugs

Use a combination of anticoagulant or antiplatelet drugs， group 2

Drug: anticoagulant or antiplatelet drugs

Interventions

anticoagulant or antiplatelet drugs DRUG

combination of anticoagulant or antiplatelet drugs

Use a combination of anticoagulant or antiplatelet drugs ， group 1; Use a combination of anticoagulant or antiplatelet drugs， group 2

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Intracavitary therapy for lower extremity arteriosclerosis obliterans

You may qualify if:

• Age ≥50 years old
• Patients with symptomatic PAD
• Moderate intermittent claudication, or severe limb ischemia
• Radiographically confirmed occlusion
• Received a successful revascularization

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (1)

First Affiliated Hospital of Zhejiang University

Hangzhou, None Selected, 310003, China

RECRUITING

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Anticoagulants; Platelet Aggregation Inhibitors

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

Hematologic Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 10, 2023
• Study Start: January 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: January 1, 2026
• Last Updated: May 10, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations

CN (1)