Description
Made available in DSpace on 2020-12-12T02:25:22Z (GMT). No. of bitstreams: 0 Previous issue date: 2020-09-01
Background: New antithrombotic strategies that reduce primary thrombosis and restenosis might improve vascular outcomes in patients with peripheral artery disease (PAD) undergoing arterial angioplasty. The study objective is to evaluate the potential benefit of apixaban plus aspirin compared with standard of care dual antiplatelet therapy (DAPT) in reducing thrombotic restenosis and artery re-occlusion in patients undergoing endovascular infrapopliteal revascularization. Study design: This multicenter, parallel-group, prospective, randomized, open-label, blinded-endpoint adjudication, proof-of-concept, exploratory trial aims to randomize 200 patients 72 hours after successful infrapopliteal angioplasty for critical limb ischemia (CLI). Patients will be randomly assigned in a 1:1 ratio to receive oral apixaban (2.5 mg twice daily) plus aspirin (100 mg once daily) for 12 months or clopidogrel (75 mg daily) for at least 3 months on a background of aspirin (100 mg once daily) for 12 months. The primary endpoint is the composite of target lesion revascularization (TLR), major amputation, or restenosis/occlusion (RAS) in addition to major adverse cardiovascular events – MACE (myocardial infarction, stroke or cardiovascular death) at 12 months. The primary safety endpoint is the composite of major bleeding or clinically relevant non-major bleeding at 12 months. This study will evaluate the efficacy and safety of apixaban 2.5 mg twice daily plus aspirin compared with DAPT (clopidogrel plus aspirin) in patients with CLI undergoing endovascular infrapopliteal revascularization and might prove the concept of an alternative antithrombotic regimen for these patients to be tested in a future large randomized clinical trial.
São Paulo State Public Servant Hospital
Duke Clinical Research Institute Duke University School of Medicine
Science Valley Research Institute
Albert Einstein Hospital
Universidade Estadual Paulista (UNESP)
Santa Casa de Maceio Maceio
Hospital das Clínicas de Ribeirão Preto São Paulo University Medical School (USP)
Santa Casa de São Paulo School of Medical Sciences
Beneficência Portuguesa de São Paulo
Hospital das Clínicas de São Paulo São Paulo University
Vascular and Endovascular Surgery–Federal University of Bahia
Federal University of São Paulo
Inova Heart and Vascular Institute
Hemostasis & Thrombosis Research Laboratories at Loyola University Medical Center
Universidade Estadual Paulista (UNESP)
