Back to resultsStudy to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Primary Purpose
Acute Coronary Syndrome, Percutaneous Coronary Intervention
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ticagrelor
Clopidogrel
Acetylsalicylic acid ASA
Sponsored by
About this trial
This is an interventional treatment trial for Acute Coronary Syndrome focused on measuring acute coronary syndrome, coronary disease, coronary artery disease
Eligibility Criteria
Inclusion Criteria:
- Provision of signed informed consent
- Index event of non-ST or ST segment elevation ACS
Exclusion Criteria:
- Index event is an acute complication of percutaneous coronary intervention
- Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
- Oral anticoagulation therapy that cannot be stopped
- The conditions associated with increased risk of bradycardiac events
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Ticagrelor (AZD6140)
Clopidogrel
Outcomes
Primary Outcome Measures
Major Bleeding
Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Major Adverse Cardiac Events (MACE)
Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Secondary Outcome Measures
Major and Minor Bleeding
Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Composite of All-cause Mortality, MI or Stroke
Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01294462
Brief Title
Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
Official Title
A Randomised, Double-blind, Double-dummy, Parallel Group, International (Asian), Multicenter, Phase 3 Study to Assess Safety and Efficacy of AZD6140 on Top of Low Dose Acetyl Salicylic Acid (ASA) Versus Clopidogrel on Top of Low Dose ASA in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes(ACS) for Whom PCI is Planned
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome, Percutaneous Coronary Intervention
Keywords
acute coronary syndrome, coronary disease, coronary artery disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
801 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Ticagrelor (AZD6140)
Arm Title
2
Arm Type
Active Comparator
Arm Description
Clopidogrel
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Other Intervention Name(s)
AZD6140
Intervention Description
90 mg, oral dose twice daily
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Other Intervention Name(s)
Plavix
Intervention Description
75 mg, oral dose once daily
Intervention Type
Drug
Intervention Name(s)
Acetylsalicylic acid ASA
Intervention Description
Low Dose ASA
Primary Outcome Measure Information:
Title
Major Bleeding
Description
Time to first occurrence of any major bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Time Frame
Ongoing up to12 months
Title
Major Adverse Cardiac Events (MACE)
Description
Time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Time Frame
Ongoing up to 12 months
Secondary Outcome Measure Information:
Title
Major and Minor Bleeding
Description
Time to first occurrence of any major or minor bleeding event (adjudicated by an independent Clinical Endpoint Committee (ICEC)). 1-year event rate (%) estimated via Kaplan-Meier method.
Time Frame
Ongoing up to12 months
Title
Composite of All-cause Mortality, MI or Stroke
Description
Time to first occurrence of any event from the composite of death from any causes, Myocardial Infarction (MI) and stroke (adjudicated by an ICEC). 1-year event rate (%) estimated via Kaplan-Meier method.
Time Frame
Ongoing up to 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed informed consent
Index event of non-ST or ST segment elevation ACS
Exclusion Criteria:
Index event is an acute complication of percutaneous coronary intervention
Patient has undergone Percutaneous Coronary Intervention (PCI) after the index event before the first dose of study treatment
Oral anticoagulation therapy that cannot be stopped
The conditions associated with increased risk of bradycardiac events
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Judith Hsia, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Ichinomiya-shi
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Nagoya-shi
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Okazaki-shi
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Toyohashi-shi
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Toyota-shi
State/Province
Aichi
Country
Japan
Facility Name
Research Site
City
Akita-shi
State/Province
Akita
Country
Japan
Facility Name
Research Site
City
Ichihara-shi
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Kamogawa-shi
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Kisarazu-shi
State/Province
Chiba
Country
Japan
Facility Name
Research Site
City
Matsuyama
State/Province
Ehime
Country
Japan
Facility Name
Research Site
City
Fukui-shi
State/Province
Fukui
Country
Japan
Facility Name
Research Site
City
Fukuoka-shi
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Kasuya-gun
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Kurume
State/Province
Fukuoka
Country
Japan
Facility Name
Research Site
City
Gifu-shi
State/Province
Gifu
Country
Japan
Facility Name
Research Site
City
Isesaki
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Maebashi
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Takasaki-shi
State/Province
Gunma
Country
Japan
Facility Name
Research Site
City
Kure
State/Province
Hiroshima
Country
Japan
Facility Name
Research Site
City
Sapporo-shi
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Research Site
City
Akashi-shi
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Amagasaki-shi
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kawanishi-shi
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kobe-shi
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Kobe
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Nishinomiya
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Takarazuka-shi
State/Province
Hyogo
Country
Japan
Facility Name
Research Site
City
Higashiibaragi-gun
State/Province
Ibaragi
Country
Japan
Facility Name
Research Site
City
Sashima-gun
State/Province
Ibaragi
Country
Japan
Facility Name
Research Site
City
Hakusan-shi
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Kanazawa-shi
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Kanazawa
State/Province
Ishikawa
Country
Japan
Facility Name
Research Site
City
Sakaide-shi
State/Province
Kagawa
Country
Japan
Facility Name
Research Site
City
Atsugi-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Isehara
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kamakura-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Kawasaki-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Sagamihara-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yamato-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Yokohama-shi
State/Province
Kanagawa
Country
Japan
Facility Name
Research Site
City
Nankoku-shi
State/Province
Kochi
Country
Japan
Facility Name
Research Site
City
Kumamoto-shi
State/Province
Kumamoto
Country
Japan
Facility Name
Research Site
City
Yatsushiro-city
State/Province
Kumamoto
Country
Japan
Facility Name
Research Site
City
Kyoto-shi
State/Province
Kyoto
Country
Japan
Facility Name
Research Site
City
Sendai-shi
State/Province
Miyagi
Country
Japan
Facility Name
Research Site
City
Azumino-shi
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Ueda-shi
State/Province
Nagano
Country
Japan
Facility Name
Research Site
City
Nagasaki-shi
State/Province
Nagasaki
Country
Japan
Facility Name
Research Site
City
Kurashiki
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Okayama-shi
State/Province
Okayama
Country
Japan
Facility Name
Research Site
City
Hirakata
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Kawachinagano-shi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Osaka-shi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Sakai-shi
State/Province
Osaka
Country
Japan
Facility Name
Research Site
City
Saga-shi
State/Province
Saga
Country
Japan
Facility Name
Research Site
City
Ageo-shi
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Hidaka
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Sayama-shi
State/Province
Saitama
Country
Japan
Facility Name
Research Site
City
Kusatsu-shi
State/Province
Shiga
Country
Japan
Facility Name
Research Site
City
Moriyama
State/Province
Shiga
Country
Japan
Facility Name
Research Site
City
Matsue
State/Province
Shimane
Country
Japan
Facility Name
Research Site
City
Hamamatsu-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Izunokuni
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Shimada-shi
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Sunto-gun
State/Province
Shizuoka
Country
Japan
Facility Name
Research Site
City
Komatsushima-shi
State/Province
Tokushima
Country
Japan
Facility Name
Research Site
City
Tokushima-shi
State/Province
Tokushima
Country
Japan
Facility Name
Research Site
City
Adachi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Bunkyo
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Chiyoda-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Itabashi-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Meguro
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Ome-shi
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinagawa-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Shinjuku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Suginami-ku
State/Province
Tokyo
Country
Japan
Facility Name
Research Site
City
Tanabe-shi
State/Province
Wakayama
Country
Japan
Facility Name
Research Site
City
Chuo-shi
State/Province
Yamanashi
Country
Japan
Facility Name
Research Site
City
Fukuoka
Country
Japan
Facility Name
Research Site
City
Gifu
Country
Japan
Facility Name
Research Site
City
Kumamoto
Country
Japan
Facility Name
Research Site
City
Oita
Country
Japan
Facility Name
Research Site
City
Saga
Country
Japan
Facility Name
Research Site
City
Wakayama
Country
Japan
Facility Name
Research Site
City
Cheonan
State/Province
Chungcheongnam-do
Country
Korea, Republic of
Facility Name
Research Site
City
Daejeon
Country
Korea, Republic of
Facility Name
Research Site
City
Incheon
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
Facility Name
Research Site
City
Niao-song-shiang
State/Province
Kaohsiung
Country
Taiwan
Facility Name
Research Site
City
Kweishan Shiang
State/Province
Taoyuan Hsien
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=473&filename=CSR-D5130C00027.pdf
Description
CSR-D5130C00027.pdf
Learn more about this trial
Study to Assess Safety and Efficacy of Ticagrelor (AZD6140) Versus Clopidogrel in Asian/Japanese Patients With Non-ST or ST Elevation Acute Coronary Syndromes (ACS)
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