Optimizing Antithrombotic Care in patients with AtriaL fibrillatiON and coronary stEnt study

Optimizing Antithrombotic Care in patients with AtriaL fibrillatiON and coronary stEnt study - OAC-ALONE Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010900

Enrollment

2000

Registered

2013-06-10

Start date

2013-11-05

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation (AF) Coronary artery disease post stenting

Interventions

Oral anticoagulant (OAC) monotherapy. OAC includes warfarin or NOAC. The dose of warfarin should be adjusted with the target international normalized ratio (INR) range of 2.0-3.0 for those &lt

70 years and 1.6-2.6 for those =&gt

70 years, which is recommended in the Japanese guidelines. NOAC includes dabigatran 150mg or 110mg twice daily, rivaroxaban 15mg daily with the reduced dose of 10mg daily, apixaban 5mg twice daily

Eligibility

Sex/Gender

All

Inclusion 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

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.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of this study is a composite of all-caused death, myocardial infarction, and stroke or systemic embolism.	—

Secondary

Measure	Time frame
The secondary endpoints of this study are individual components of the primary endpoint, cardiovascular death, major bleeding, and stent thrombosis.	—

Countries

Japan

Contacts

Public ContactSatoshi Shizuta

Kyoto University Graduate School of Medicine Department of Cardiovascular Medicine

shizuta@kuhp.kyoto-u.ac.jp075-751-4255

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026