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Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in PAD Patients.

2020-01-22 12:13:01 | BioPortfolio

Summary

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.

Description

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 Design

Conditions

Critical Limb Ischemia

Intervention

Apixaban, ASA, Clopidogrel 75mg

Location

IAMSPE - Sao Paulo Public Servants Hospital
São Paulo
Brazil
04039000

Status

Recruiting

Source

Science Valley Research Institute

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-01-22T12:13:01-0500

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