drugset / Trial / NCT02567461

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

NCT02567461

Phase 4 Completed 80 enrolled University of Florida Daiichi Sankyo · collab
RandomizedParallel-groupOpen-labelTreatment

Summary

It is not uncommon that patients requiring dual antiplatelet therapy (DAPT) also need to be treated with oral anticoagulant therapy, such as those with atrial fibrillation (AF). Warfarin and clopidogrel are still the most widely utilized oral anticoagulant and P2Y12 receptor inhibitor, respectively. However, over the past years, several non-vitamin K antagonist oral anticoagulants, including edoxaban, have been studied in the setting of AF showing encouraging safety and efficacy profiles as compared with warfarin. However, the effects of edoxaban in combination with DAPT in the setting of patients with coronary artery disease (CAD) are unexplored. Moreover, the role of edoxaban as part of a dual antithrombotic treatment strategy, including clopidogrel and stopping aspirin, represents another important area of clinical interest. This investigation is a prospective, randomized, parallel-design, open label, pharmacodynamic study conducted in patients with CAD on DAPT with aspirin and clopidogrel testing two different edoxaban dosing regimens in addition to DAPT with aspirin and clopidogrel, as well as in combination with clopidogrel only (after stopping aspirin).

Timeline

Start
2016-03
Primary completion
2017-10
Completion
2018-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Aspirin Small molecule 81 mg
Subject Edoxaban Small molecule 15 mg
Subject Edoxaban Small molecule 30 mg
Subject Edoxaban Small molecule 60 mg
Background Clopidogrel Small molecule 75 mg