This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared to the standard treatment (clopidogrel plus aspirin) in patients with critical limb ischemia undergoing infrapopliteal arterial endovascular intervention.
This study is a multicentre, parallel-group, prospective, randomized open-label, blinded-endpoint adjudication, proof-of-concept, and exploratory trial. Two hundred patients will be randomized in a 1:1 ratio, 72 hours after successful infrapopliteal angioplasty for critical limb ischemia. In the study group, patients will receive oral apixaban 2.5mg twice daily plus aspirin 100 mg once-daily for 12 months. In the control group, aspirin 100 mg once-daily will be taken for 1 year on a background of clopidogrel (75mg daily) for the first three months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation or restenosis/occlusion (RAS) plus MACE (myocardial infarction, stroke, and cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding and clinically relevant non-major bleeding at 12 months.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Oral Apixaban 2.5 mg twice daily for one year
Acetil Salicilic Acid 100mg once daily for one year
Clopidogrel 75mg once daily for 3 months
IAMSPE - Sao Paulo Public Servants Hospital
São Paulo, Brazil
RECRUITINGRestenosis of the treated infrapopliteal artery
Number of patients with absence of flow or \>2.4 sistolic index obtained by Duplex Scan
Time frame: 12 months
Major amputation
Number of patients who underwent amputation of the leg above the ankle
Time frame: 12 months
Clinical driven-target lesion revascularization
Number of patients who was submitted by reintervention of the treated infrapopliteal artery based on the clinical status
Time frame: 12 months
Major cardiovascular events
Number of patients who present one of those: myocardial infarction, stroke and cardiovascular death
Time frame: 12 months
Bleeding
Number of patients who present major bleeding (MB) or clinically relevant non-major bleeding, using the ISTH criteria
Time frame: 12 months
Healing
Time to total healing measured by the Imitomeasure program.
Time frame: 12 months
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