Edoxaban in Peripheral Arterial Disease

Summary

This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess the safety and potential efficacy of adding edoxaban to aspirin following femoropopliteal endovascular intervention, with or without stent placement, relative to current treatment practice with clopidogrel and aspirin.

Timeline

Start

2013-02-06

Primary completion

2014-12-03

Completion

2014-12-03

Outcome

Missed primary endpoint

registry Treatment Difference -3.9 (95% CI -17.3 to 9.5) NCT01802775 ↗

paper The incidence of restenosis/reocclusion events, while not statistically different, was lower with edoxaban and aspirin PMID 29552984 ↗

Publications

• Moll F, Baumgartner I, Jaff M, Nwachuku C, Tangelder M, Ansel G, Adams G, Zeller T, Rundback J, Grosso M, Lin M, Mercur MF, Minar E; ePAD Investigators. Edoxaban Plus Aspirin vs Dual Antiplatelet Therapy in Endovascular Treatment of Patients With Peripheral Artery Disease: Results of the ePAD Trial. J Endovasc Ther. 2018 Apr;25(2):158-168. doi: 10.1177/1526602818760488.
• Tangelder MJ, Nwachuku CE, Jaff M, Baumgartner I, Duggal A, Adams G, Ansel G, Grosso M, Mercuri M, Shi M, Minar E, Moll FL. A review of antithrombotic therapy and the rationale and design of the randomized edoxaban in patients with peripheral artery disease (ePAD) trial adding edoxaban or clopidogrel to aspirin after femoropopliteal endovascular intervention. J Endovasc Ther. 2015 Apr;22(2):261-8. doi: 10.1177/1526602815574687.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Clopidogrel	Small molecule	75 mg	—
Subject	Edoxaban	Small molecule	30 mg	Oral
Subject	Edoxaban	Small molecule	60 mg	Oral
Background	Aspirin	Small molecule	100 mg	—

Indications