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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Kyoto University, Graduate School of Medicine
Sponsor:
Collaborators:
Research Institute for Production Development
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Satoshi Shizuta, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier:
NCT01962545
First received: October 5, 2013
Last updated: May 18, 2014
Last verified: May 2014

October 5, 2013
May 18, 2014
October 2013
December 2014   (final data collection date for primary outcome measure)
The primary endpoint of this study is a composite of all-caused 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: 1.5-year). ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01962545 on ClinicalTrials.gov Archive Site
  • Stent thrombosis. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
    Stent thrombosis.
  • Myocardial infarction. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
    One of the individual components of the primary endpoint.
  • Stroke or systemic embolism. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
    One of the individual components of the primary endpoint.
  • All-caused death. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
    One of the individual components of the primary endpoint.
  • Major bleeding. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
  • Cardiovascular death. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
  • Stent thrombosis. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
    Stent thrombosis.
  • Myocardial infarction. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
    One of the individual components of the promary endpoint.
  • Stroke or systemic embolism. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
    One of the individual components of the promary endpoint.
  • All-caused death. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
    One of the individual components of the promary endpoint.
  • Major bleeding. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
  • Cardiovascular death. [ Time Frame: Day-0 to the day when the finally enrolled patient complete 1-year follow-up (anticipated mean duration: 1.5-year). ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study
Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study

The purpose of the study is to evaluate non-inferiority of warfarin monotherapy to warfarin plus aspirin in patients with atrial fibrillation (AF) and prior (>12 months) coronary stenting.

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 oral anticoagulation (OAC) to prevent stroke or systemic thromboembolism, and also for antiplatelet therapy (APT) to prevent ischemic cardiac events, particularly stent thrombosis (ST). However, combined use of OAC and ATP is associated with increased risk of major bleeding. Thus, we need to balance the risk for stroke or systemic thromboembolic events and coronary events against the risk for bleeding.

The AF guideline of European Society of Cardiology (ESC) published in 2010 recommended OAC alone with vitamin-K antagonist (VKA) as life-long antithrombotic therapy after 12 months of combined use of OAC plus APT in AF patients undergoing coronary stenting. However, no randomized controlled trials (RCTs) and few observational data support this recommendation. Aspirin monotherapy is the commonly used APT regimen in non-AF patients beyond 1 year after coronary stenting. No APT coverage after coronary stenting was reported to be associated with increased risk for ST. It is currently unknown whether OAC is equally effective as aspirin in preventing very late ST beyond 1 year after stenting, although several RCTs have shown that VKA was at least as effective as aspirin for the secondary prevention of ischemic cardiac events in patients mostly without coronary stent.

Therefore, we planned a prospective randomized controlled open label trial comparing warfarin alone versus warfarin plus aspirin in AF patients beyond 1 year after coronary stenting.

The patient enrollment period is 1-year and follow-up duration is at least 1-year. Therefore, the anticipated mean follow-up duration is 1.5-year.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Atrial Fibrillation
  • Coronary Artery Disease
  • Drug: Warfarin.
  • Drug: Warfarin plus aspirin.
  • Active Comparator: Warfarin alone
    Adjusted dose warfarin 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.
    Intervention: Drug: Warfarin.
  • Active Comparator: Warfarin plus aspirin
    Adjusted dose warfarin 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. The dose of aspirin is 81-324mg/day.
    Intervention: Drug: Warfarin plus aspirin.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
February 2015
December 2014   (final data collection date for primary outcome measure)

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 warfarin and aspirin, but not with other antiplatelet drugs including thienopyridine and cilostazol.
  3. Patients with an INR value of => 1.6 at enrollment.
  4. Patients who agreed to receive warfarin therapy 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.
  5. Patients able to receive periodical follow-up including INR monitoring and dose-adjustment of warfarin at the participating centers.
  6. Patients with written informed consent.

Exclusion Criteria:

  1. Patients who underwent PCI including balloon angioplasty alone within the past 12 months.
  2. Patients intolerant for anticoagulation with warfarin according to the Japanese guidelines in combination with aspirin.
  3. Patients in whom warfarin therapy is scheduled to be discontinued during the follow-up period (maximum; 2 years).
  4. Patients with a past history of stent thrombosis.
  5. Patients in whom antiplatelet drugs including aspirin cannot be discontinued.
  6. Patients with a planned coronary revascularization.
  7. Patients with a planned cardiovascular or non-cardiovascular surgery.
  8. Patients with expectation of survival less than one year.
Both
20 Years and older
No
Contact: Takeshi Kimura, M.D. +81-75-751-4254 taketaka@kuhp.kyoto-u.ac.jp
Contact: Satoshi Shizuta, M.D. +81-75-751-3198 shizuta@kuhp.kyoto-u.ac.jp
Japan
 
NCT01962545
C740
Yes
Satoshi Shizuta, Kyoto University, Graduate School of Medicine
Satoshi Shizuta
  • Research Institute for Production Development
  • Daiichi Sankyo Co., Ltd.
Principal Investigator: Takeshi Kimura, M.D. Kyoto University, Graduate School of Medicine
Kyoto University, Graduate School of Medicine
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP