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

• Status: Completed
• Trial end date: 2018-03-15
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Florida
• Collaborators: Daiichi Sankyo Inc.; Daiichi Sankyo, Inc.
• Treatments: Aspirin; Clopidogrel; Edoxaban; Ticlopidine

Criteria

Inclusion criteria:

1. Patients with angiographically documented CAD (previous PCI or ACS).

2. On DAPT with low-dose aspirin (81mg od) and clopidogrel for at least 30 days as per standard-of-care.

3. Age above 18.

Exclusion criteria:

1. Active pathological bleeding, history of clinically significant bleeding events, or deemed at increased risk of bleeding.

2. CrCL <15mL/min

3. Any clinical indication to be on anticoagulant therapy

4. Acute coronary events in the past 90 days

5. Prior hemorrhagic stroke or intracranial hemorrhage

6. Ischemic stroke/transient ischemic attack in the past 6 months

7. Chronic use of nonsteroidal anti-inflammatory drugs

8. On treatment with rifampin (induce or P-gp transporter)

9. Known moderate or severe hepatic impairment (Child-Pugh B and C).

10. On treatment with any antiplatelet agent other than aspirin and clopidogrel in the past 30 days.

11. Platelet count <80x106/mL

12. Hemoglobin <10g/dL

13. Hemodynamic instability

14. Pregnant females [women of childbearing age must use reliable birth control (i.e. oral contraceptives) while participating in the study].