Clinical trial NCT05852197: Effect of Anticoagulant Drug Intervention on Postoperative MALE and MACE in Patients With PAD
Official title: Effect of Anticoagulant Drug Intervention on postoperativeMajor Adverse Limb Events and Major Adverse Cardiovascular Events in Patients With Peripheral Arterial Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anticoagulant Drugs
Antiplatelet Drug
Peripheral Arterial Disease
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 6000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intracavitary therapy for lower extremity arteriosclerosis obliterans

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.


Eligibility criteria: 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

Primary outcomes:
measure: Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
timeFrame: The 1st month after treatment
measure: Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
timeFrame: The 3rd month after treatment
measure: Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
timeFrame: The 6th month after treatment
measure: Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
timeFrame: The 9th month after treatment
measure: Composite adverse event incidence (MACE/MALE) : myocardial infarction, ischemic stroke, acute limb ischemia, major amputation due to vascular disease
timeFrame: The 12th month after treatment
Secondary outcomes:
measure: MACE
timeFrame: The 1st，3rd，6th，9th，12th month
measure: MALE
timeFrame: The 1st，3rd，6th，9th，12th month
measure: Compound protection from vasogenic adverse events
timeFrame: The 1st，3rd，6th，9th，12th month
measure: all-cause mortality
timeFrame: The 1st，3rd，6th，9th，12th month
measure: health economics evaluation
timeFrame: The 1st，3rd，6th，9th，12th month
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: First Affiliated Hospital of Zhejiang University
state: None Selected
Study officials:
References: