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
  Purpose

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.


Condition Intervention Phase
Atrial Fibrillation
Coronary Artery Disease
Drug: Warfarin.
Drug: Warfarin plus aspirin.
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing Antithrombotic Care in Patients With AtriaL fibrillatiON and Coronary stEnt (OAC-ALONE) Study

Resource links provided by NLM:


Further study details as provided by Kyoto University, Graduate School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 2000
Study Start Date: October 2013
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Drug: Warfarin plus aspirin.

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 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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962545

Contacts
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

Locations
Japan
Kyoto University Graduate School of Medicine Recruiting
Kyoto, Japan, 606-8507
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   
Principal Investigator: Takeshi Kimura, M.D.         
Sponsors and Collaborators
Satoshi Shizuta
Research Institute for Production Development
Daiichi Sankyo Co., Ltd.
Investigators
Principal Investigator: Takeshi Kimura, M.D. Kyoto University, Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Satoshi Shizuta, Kyoto University, Kyoto University, Graduate School of Medicine
ClinicalTrials.gov Identifier: NCT01962545     History of Changes
Other Study ID Numbers: C740
Study First Received: October 5, 2013
Last Updated: May 18, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyoto University, Graduate School of Medicine:
Atrial Fibrillation
Percutaneous coronary intervention
Stent
Anticoagulant therapy
Antiplatelet therapy

Additional relevant MeSH terms:
Atrial Fibrillation
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Aspirin
Warfarin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014