Atrial FibrillationPhase 4OAC-ALONENCT01962545
Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study
A Phase 4 study testing OAC alone in people with Atrial Fibrillation and Coronary Artery Disease, run by Satoshi Shizuta at 1 site in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Atrial Fibrillation, Coronary Artery Disease
- What is being tested?
- OAC alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 690 participants
- Where
- 1 siteJapan
- Study dates
- 5 Nov 2013to 18 May 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
It has been reported that 5-10% of patients undergoing percutaneous coronary intervention (PCI) have concomitant AF. Most of those patients have an indication for OAC therapy to prevent stroke or systemic thromboembolism, and also for APT to prevent ischemic cardiac events, particularly myocardial infarction (MI) due to stent thrombosis (ST). However, combined use of OAC and APT is associated with increased risk of major bleeding. Thus, we need to balance the risk for stroke or systemic thromboembolism and coronary events against the risk for bleeding complications.
The AF guidelines of European Society of Cardiology (ESC) published in 2010 recommended vitamin-K antagonist (VKA) monotherapy as life-long antithrombotic therapy after 12 months of combined use of VKA plus APT in AF patients undergoing coronary stenting. Single APT with either aspirin or clopidogrel is the commonly used APT regimen in non-AF patients beyond 1-year after PCI-stenting. No APT coverage after coronary stenting was reported to be associated with increased risk for ST. It has not yet been thoroughly clarified whether VKA monotherapy is equally effective as single APT in the prevention of ST, although several RCTs have shown that VKA was more effective than aspirin for the secondary prevention of ischemic cardiac events in post-MI patients mostly untreated with coronary stent, and recent observational studies have suggested the safety of VKA monotherapy beyond 1-year after PCI-stenting. Nevertheless, there have been no RCTs focusing the safety of VKA monotherapy for AF patients in the chronic phase of PCI-stenting.
Also, because phase-3 RCTs comparing warfarin and non-VKA OAC (NOAC) in the prevention of stroke or systemic embolism in AF patients showed no significant difference in the incidence of MI during follow-up, the consensus document of ESC published in 2014 recommended OAC monotherapy with either VKA or NOAC as life-long antithrombotic therapy beyond 1-year after coronary stenting for AF patients. However, there have been no RCTs or observational studies demonstrating the safety of NOAC alone beyond 1-year after PCI-stenting.
Accordingly, we planned a prospective randomized controlled open label trial comparing OAC alone versus OAC plus single APT in AF patients beyond 1-year after PCI-stenting. AF patients receiving OAC with either warfarin or NOAC in combination with single APT with either aspirin or clopidogrel, who underwent PCI-stenting more than 12 months ago, are eligible for the study. Patients are randomly assigned to OAC alone (intervention arm, discontinuing single APT) or OAC plus single APT (control arm, no change in antithrombotic therapy).
The patient enrollment period is approximately 3 years and follow-up duration is at least 1 year. Therefore, the anticipated mean follow-up duration is approximately 2.5-year.
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Being tested
- OAC alone
- Keywords
- Atrial Fibrillation, Percutaneous coronary intervention, Stent, Anticoagulant therapy, Antiplatelet therapy, Warfarin, NOAC, Aspirin, Clopidogrel
- Medical subject headings
- Atrial Fibrillation, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OAC aloneDrug
Single APT with either aspirin or clopidogrel is discontinued in this arm.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint of this study is a composite of all-cause death, myocardial infarction, and stroke or systemic embolism.
Measured: 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.
Measured: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Stent thrombosis.
Stent thrombosis.
Measured: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Myocardial infarction.
One of the individual components of the primary endpoint.
Measured: 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.
One of the individual components of the primary endpoint.
Measured: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
All-cause death.
One of the individual components of the primary endpoint.
Measured: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Major bleeding.
One of the individual components of the major secondary endpoint.
Measured: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Cardiovascular death.
Measured: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Heart failure hospitalization.
Measured: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2013 (estimated)
- Study start5 Nov 2013
- Primary completion18 May 2017
- Study completion18 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 690 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satoshi Shizuta
- Sponsor type
- University, hospital or other
- Collaborators
- Research Institute for Production Development, Daiichi Sankyo Co., Ltd.
- Responsible party
- Sponsor-investigator, Satoshi Shizuta, Kyoto University, Graduate School of Medicine
- Investigators
- Takeshi Kimura, M.D., Principal investigator, Kyoto University, Graduate School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01962545
- Sponsor's protocol ID
- C740
- Acronym
- OAC-ALONE
- Status last verified
- Jun 2018
- First submitted
- 5 Oct 2013
- Last updated
- 11 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 30586700
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study
- ClinicalTrials.gov ID
- NCT01962545
- Acronym / sponsor ID
- OAC-ALONE / C740
- Conditions
- Atrial Fibrillation, Coronary Artery Disease
- Keywords
- Atrial Fibrillation, Percutaneous coronary intervention, Stent, Anticoagulant therapy, Antiplatelet therapy, Warfarin, NOAC, Aspirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 690 participants (actual)
- Lead sponsor
- Satoshi ShizutaUniversity, hospital or other
- Collaborators
- Research Institute for Production Development, Daiichi Sankyo Co., Ltd.
- Study start
- 5 Nov 2013 (actual)
- Primary completion
- 18 May 2017 (actual)
- Study completion
- 18 May 2018 (actual)
- First posted
- 14 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
It has been reported that 5-10% of patients undergoing percutaneous coronary intervention (PCI) have concomitant AF. Most of those patients have an indication for OAC therapy to prevent stroke or systemic thromboembolism, and also for APT to prevent ischemic cardiac events, particularly myocardial infarction (MI) due to stent thrombosis (ST). However, combined use of OAC and APT is associated with increased risk of major bleeding. Thus, we need to balance the risk for stroke or systemic thromboembolism and coronary events against the risk for bleeding complications.
The AF guidelines of European Society of Cardiology (ESC) published in 2010 recommended vitamin-K antagonist (VKA) monotherapy as life-long antithrombotic therapy after 12 months of combined use of VKA plus APT in AF patients undergoing coronary stenting. Single APT with either aspirin or clopidogrel is the commonly used APT regimen in non-AF patients beyond 1-year after PCI-stenting. No APT coverage after coronary stenting was reported to be associated with increased risk for ST. It has not yet been thoroughly clarified whether VKA monotherapy is equally effective as single APT in the prevention of ST, although several RCTs have shown that VKA was more effective than aspirin for the secondary prevention of ischemic cardiac events in post-MI patients mostly untreated with coronary stent, and recent observational studies have suggested the safety of VKA monotherapy beyond 1-year after PCI-stenting. Nevertheless, there have been no RCTs focusing the safety of VKA monotherapy for AF patients in the chronic phase of PCI-stenting.
Also, because phase-3 RCTs comparing warfarin and non-VKA OAC (NOAC) in the prevention of stroke or systemic embolism in AF patients showed no significant difference in the incidence of MI during follow-up, the consensus document of ESC published in 2014 recommended OAC monotherapy with either VKA or NOAC as life-long antithrombotic therapy beyond 1-year after coronary stenting for AF patients. However, there have been no RCTs or observational studies demonstrating the safety of NOAC alone beyond 1-year after PCI-stenting.
Accordingly, we planned a prospective randomized controlled open label trial comparing OAC alone versus OAC plus single APT in AF patients beyond 1-year after PCI-stenting. AF patients receiving OAC with either warfarin or NOAC in combination with single APT with either aspirin or clopidogrel, who underwent PCI-stenting more than 12 months ago, are eligible for the study. Patients are randomly assigned to OAC alone (intervention arm, discontinuing single APT) or OAC plus single APT (control arm, no change in antithrombotic therapy).
The patient enrollment period is approximately 3 years and follow-up duration is at least 1 year. Therefore, the anticipated mean follow-up duration is approximately 2.5-year.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OAC alone | Experimental | Drug: OAC aloneOAC 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. |
| 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OAC aloneSingle APT with either aspirin or clopidogrel is discontinued in this arm. | Drug | OAC alone |
Primary outcome
The primary endpoint of this study is a composite of all-cause death, myocardial infarction, and stroke or systemic embolism.
Time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
8 secondary outcomes
The major secondary endpoint of this study is a composite of all-cause death, myocardial infarction, stroke or systemic embolism, and major bleeding.
Time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Stent thrombosis.
Time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Myocardial infarction.
Time frame: 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.
Time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
All-cause death.
Time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Major bleeding.
Time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Cardiovascular death.
Time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Heart failure hospitalization.
Time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2018.
- Derived from this study: PubMed 30586700Matsumura-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.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takeshi Kimura, M.D. principal investigator
Kyoto University, Graduate School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing OAC alone in people with Atrial Fibrillation and Coronary Artery Disease, run by Satoshi Shizuta at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of this study is a composite of all-cause death, myocardial infarction, and stroke or systemic embolism. (time frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 2.5-year).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01962545, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2018.