Conditions: Peripheral Arterial Disease
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 203
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Open label edoxaban will be provided. Subjects randomized to this treatment arm will receive edoxaban 60 mg once daily (QD) (two 30 mg tablets) for a total of approximately 3 months on a background of aspirin 100 mg QD. arm 2: Open label clopidogrel will be provided. Subjects randomized to this treatment arm will receive clopidogrel 75 mg QD (one 75 mg tablet) for a total of approximately 3 months on a background of aspirin 100 mg QD. A loading dose of clopidogrel 300 mg (four 75mg tablets) will be given to subjects as the first dose as early as possible after adequate hemostasis (i.e., within 4 hours of hemostasis).

Interventions: intervention 1: edoxaban intervention 2: Clopidogrel intervention 3: Aspirin
Intervention descriptions: intervention 1: None intervention 2: 75mg tablet intervention 3: None

Protocol document: