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

  • STATUS
    Recruiting
  • participants needed
    200
  • sponsor
    Science Valley Research Institute
Updated on 25 May 2022
stenosis
aspirin
endovascular intervention
serum pregnancy test
clopidogrel
ischemia
clopidogrel 75 mg
limb ischemia
endovascular procedure

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.

Details
Condition Critical Limb Ischemia
Treatment Apixaban, ASA, Clopidogrel 75mg
Clinical Study IdentifierNCT04229264
SponsorScience Valley Research Institute
Last Modified on25 May 2022

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