NCT04229264

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

Efficacy and Safety of Apixaban in Reducing Restenosis and Limb Loss in Subjects With Symptomatic Peripheral Artery Disease (PAD) Undergoing Infrapopliteal Endovascular Peripheral Revascularization Procedures in Patients With Critical Limb

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Science Valley Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Critical Limb Ischemia

Interventions

Type	Name	Description
DRUG	Apixaban	Oral Apixaban 2.5 mg twice daily for one year
DRUG	ASA	Acetil Salicilic Acid 100mg once daily for one year
DRUG	Clopidogrel 75mg	Clopidogrel 75mg once daily for 3 months

Timeline

• Start date: 2020-01-09
• Primary completion: 2022-02-02
• Completion: 2022-05-02
• First posted: 2020-01-18
• Last updated: 2021-04-20

Locations

1 site across 1 country: Brazil