Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study

• Status: Completed
• Trial end date: 2018-05-18
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate non-inferiority of oral anticoagulant (OAC) monotherapy to OAC plus single antiplatelet therapy (APT) in patients with atrial fibrillation (AF) and prior (>12 months) coronary stenting.

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

Details

• Lead Sponsor: Satoshi Shizuta
• Collaborators: Daiichi Sankyo Co., Ltd.; Research Institute for Production Development
• Treatments: Aspirin; Clopidogrel; Warfarin

Criteria

Inclusion Criteria:

1. Patients with a documented history of AF who underwent PCI with stenting >12 months before enrollment.

2. Patients who are treated with OAC (warfarin or NOAC) and an antiplatelet drug (aspirin or clopidogrel), but not with other antiplatelet drugs including ticlopidine, prasugrel, ticagrelor, and cilostazol.

3. In patients treated with warfarin, the INR value at enrollment should be => 1.6, and agreement on dose adjustment of warfarin with the target INR range of 2.0-3.0 for those <70 years and 1.6-2.6 for those =>70 years, which is recommended in the Japanese guidelines, is necessary before enrollment.

4. Patients 20 years or older.

5. Patients with written informed consent.

Exclusion Criteria:

1. Patients who underwent PCI including balloon angioplasty alone within the past 12 months.

2. Patients in whom OAC is scheduled to be discontinued during the follow-up period.

3. Patients with a past history of ST.

4. Patients with a planned coronary revascularization.

5. Patients with a planned cardiovascular or non-cardiovascular surgery.

6. Patients with expectation of survival less than one year.