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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05852197

Enrollment

6000

Registered

2023-05-10

Start date

2023-01-01

Completion date

2026-01-01

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulant Drugs, Antiplatelet Drug, Peripheral Arterial Disease

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.

Interventions

DRUGanticoagulant or antiplatelet drugs

combination of anticoagulant or antiplatelet drugs

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

Measure	Time frame	Description
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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026