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

NCT01962545 | Completed Phase 4 DMC

• 1 other identifier: C740
• Study Type: interventional
• Target: 690
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Atrial Fibrillation; Coronary Artery Disease

Keywords

Atrial Fibrillation; Percutaneous coronary intervention; Stent; Anticoagulant therapy; Antiplatelet therapy; Warfarin; NOAC; Aspirin; Clopidogrel

Outcome Measures

Primary Outcomes (1)

• The primary endpoint of this study is a composite of all-cause death, myocardial infarction, and stroke or systemic embolism.

  Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).

Secondary Outcomes (8)

• The major secondary endpoint of this study is a composite of all-cause death, myocardial infarction, stroke or systemic embolism, and major bleeding.

  Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).

• Stent thrombosis.

  Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).

• Myocardial infarction.

  Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).

• Stroke or systemic embolism.

  Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).

• All-cause death.

  Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).

Study Arms (2)

OAC alone

EXPERIMENTAL

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 \<70 years and 1.6-2.6 for those =\>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 with the reduced dose of 2.5mg twice daily, and edoxaban 60mg daily with the reduced dose of 30mg daily.

Drug: OAC alone

OAC plus single APT

NO INTERVENTION

OAC includes warfarin or NOAC. The dose of warfarin should be adjusted 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. NOAC includes dabigatran 150mg or 110mg twice daily, rivaroxaban 15mg daily with the reduced dose of 10mg daily, apixaban 5mg twice daily with the reduced dose of 2.5mg twice daily, and edoxaban 60mg daily with the reduced dose of 30mg daily. Single APT includes aspirin or clopidogrel. The dose of aspirin is 81-324mg/day and the dose of clopidogrel is 75mg/day.

Interventions

OAC alone DRUG

Single APT with either aspirin or clopidogrel is discontinued in this arm.

OAC alone

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a documented history of AF who underwent PCI with stenting \>12 months before enrollment.
• 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.
• 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.
• Patients 20 years or older.
• Patients with written informed consent.

You may not qualify if:

• Patients who underwent PCI including balloon angioplasty alone within the past 12 months.
• Patients in whom OAC is scheduled to be discontinued during the follow-up period.
• Patients with a past history of ST.
• Patients with a planned coronary revascularization.
• Patients with a planned cardiovascular or non-cardiovascular surgery.
• Patients with expectation of survival less than one year.

Sponsors & Collaborators

• Satoshi Shizuta: lead
• Research Institute for Production Development: collaborator
• Daiichi Sankyo Co., Ltd.: collaborator

Study Sites (1)

Kyoto University Graduate School of Medicine

Kyoto, 606-8507, Japan

Location

Related Publications (1)

• Matsumura-Nakano Y, Shizuta S, Komasa A, Morimoto T, Masuda H, Shiomi H, Goto K, Nakai K, Ogawa H, Kobori A, Kono Y, Kaitani K, Suwa S, Aoyama T, Takahashi M, Sasaki Y, Onishi Y, Mano T, Matsuda M, Motooka M, Tomita H, Inoko M, Wakeyama T, Hagiwara N, Tanabe K, Akao M, Miyauchi K, Yajima J, Hanaoka K, Morino Y, Ando K, Furukawa Y, Nakagawa Y, Nakao K, Kozuma K, Kadota K, Kimura K, Kawai K, Ueno T, Okumura K, Kimura T; OAC-ALONE Study Investigators. Open-Label Randomized Trial Comparing Oral Anticoagulation With and Without Single Antiplatelet Therapy in Patients With Atrial Fibrillation and Stable Coronary Artery Disease Beyond 1 Year After Coronary Stent Implantation. Circulation. 2019 Jan 29;139(5):604-616. doi: 10.1161/CIRCULATIONAHA.118.036768.

  PMID: 30586700 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Takeshi Kimura, M.D.

  Kyoto University, Graduate School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Kyoto University

Study Record Dates

• First Submitted: October 5, 2013
• First Posted: October 14, 2013
• Study Start: November 5, 2013
• Primary Completion: May 18, 2017
• Study Completion: May 18, 2018
• Last Updated: June 11, 2018

Record last verified: 2018-06

Locations

JP (1)