Edoxaban in Patients With Coronary Artery Disease on Dual Antiplatelet Therapy With Aspirin and Clopidogrel

PHASE4CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

March 31, 2016

Primary Completion Date

October 31, 2017

Study Completion Date

March 15, 2018

Conditions
Coronary Artery Disease
Interventions
DRUG

Edoxaban 60 mg

Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.

DRUG

Edoxaban 30 mg

Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.

DRUG

Clopidogrel 75 mg

Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.

DRUG

Aspirin 81 mg

Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.

Trial Locations (1)

32209

University of Florida, Jacksonville

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Daiichi Sankyo

INDUSTRY

lead

University of Florida

OTHER