UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010900 |
|---|---|
| Receipt number | R000012753 |
| Scientific Title | Optimizing Antithrombotic Care in patients with AtriaL fibrillatiON and coronary stEnt study |
| Date of disclosure of the study information | 2013/06/10 |
| Last modified on | 2021/03/03 11:54:13 |
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Basic information
Public title
Optimizing Antithrombotic Care in patients with AtriaL fibrillatiON and coronary stEnt study
Acronym
OAC-ALONE Study
Scientific Title
Optimizing Antithrombotic Care in patients with AtriaL fibrillatiON and coronary stEnt study
Scientific Title:Acronym
OAC-ALONE Study
Region
| Japan |
Condition
Condition
Atrial fibrillation (AF)
Coronary artery disease post stenting
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint of this study is a composite of all-caused death, myocardial infarction, and stroke or systemic embolism.
Key secondary outcomes
The secondary endpoints of this study are individual components of the primary endpoint, cardiovascular death, major bleeding, and stent thrombosis.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
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 <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.
Interventions/Control_2
OAC in combination with single APT.
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.
Single APT includes aspirin or clopidogrel. The dose of aspirin is 81-324mg/day and the dose of clopidogrel is 75mg/day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key 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.
Key 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.
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Kimura |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shougoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4254
taketaka@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Shizuta |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Cardiovascular Medicine
Zip code
606-8507
Address
54 Kawahara-cho, Shougoin, Sakyo-ku, Kyoto, 606-8507, Japan
TEL
075-751-4255
Homepage URL
shizuta@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Research Institute for Production Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 10 | Day |
Related information
URL releasing protocol
http://www.ec.med.kyoto-u.ac.jp/
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.118.036768?url_ver=Z39.88-2003&rfr_id=ori:rid
Number of participants that the trial has enrolled
690
Results
During a median follow-up interval of 2.5 years, the primary end point occurred in 54 patients (15.7%) in the OAC-alone group and in 47 patients (13.6%) in the combined OAC and APT group (hazard ratio, 1.16; P=0.20 for noninferiority, P=0.45 for superiority).
The major secondary end point occurred in 67 patients (19.5%) in the OAC-alone group and in 67 patients (19.4%) in the combined OAC and APT group (hazard ratio, 0.99; P=0.016 for noninferiority, P=0.96 for superiority).
Results date posted
| 2021 | Year | 03 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Mean age was 75.0 years, and 85.2% of patients were men. OAC was warfarin in 75.2% and direct oral anticoagulants in 24.8% of patients.
Participant flow
From November 5, 2013 to December 28, 2016, a total of 696 patients were enrolled from 111 centers in Japan. Excluding 6 patients who withdrew consent, the study population consisted of 690 AF patients who had had a history of PCI-stenting =>12 months before enrollment.
Patients were randomly assigned to either OAC alone or OAC plus SAPT and were followed for a median period of 2.5 years.
Adverse events
There were no apparent adverse clinical events associated with the enrollment in the study.
Outcome measures
The primary end point was a composite of all-cause death, myocardial infarction (MI), stroke, or systemic embolism.
The major secondary end point was a composite of the primary end point or major bleeding according to the International Society on Thrombosis and Haemostasis (ISTH) classification.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2013 | Year | 09 | Month | 18 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 07 | Day |
Last modified on
| 2021 | Year | 03 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012753
| Research Plan | |
|---|---|
| Registered date | File name |
| 2021/03/03 | OAC-AloneプロトコルVer3-2+(最終更新).doc |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
