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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01294462
First received: February 10, 2011
Last updated: June 18, 2014
Last verified: May 2014
  Purpose

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).


Condition Intervention Phase
Acute Coronary Syndrome
Percutaneous Coronary Intervention
Drug: Ticagrelor
Drug: Clopidogrel
Drug: Acetylsalicylic acid ASA
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Major Bleeding [ Time Frame: Ongoing up to12 months ] [ Designated as safety issue: Yes ]
    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 Frame: Ongoing up to 12 months ] [ Designated as safety issue: No ]
    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 Frame: Ongoing up to12 months ] [ Designated as safety issue: Yes ]
    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 Frame: Ongoing up to 12 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 801
Study Start Date: February 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Ticagrelor (AZD6140)
Drug: Ticagrelor
90 mg, oral dose twice daily
Other Name: AZD6140
Drug: Acetylsalicylic acid ASA
Low Dose ASA
Active Comparator: 2
Clopidogrel
Drug: Clopidogrel
75 mg, oral dose once daily
Other Name: Plavix
Drug: Acetylsalicylic acid ASA
Low Dose ASA

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01294462

  Hide Study Locations
Locations
Japan
Research Site
Ichinomiya-shi, Aichi, Japan
Research Site
Nagoya-shi, Aichi, Japan
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Okazaki-shi, Aichi, Japan
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Toyohashi-shi, Aichi, Japan
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Toyota-shi, Aichi, Japan
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Akita-shi, Akita, Japan
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Ichihara-shi, Chiba, Japan
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Kamogawa-shi, Chiba, Japan
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Kisarazu-shi, Chiba, Japan
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Matsuyama, Ehime, Japan
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Fukui-shi, Fukui, Japan
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Fukuoka-shi, Fukuoka, Japan
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Kasuya-gun, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Gifu-shi, Gifu, Japan
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Isesaki, Gunma, Japan
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Maebashi, Gunma, Japan
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Takasaki-shi, Gunma, Japan
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Kure, Hiroshima, Japan
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Sapporo, Hokkaido, Japan
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Sapporo-shi, Hokkaido, Japan
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Akashi-shi, Hyogo, Japan
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Amagasaki-shi, Hyogo, Japan
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Kawanishi-shi, Hyogo, Japan
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Kobe, Hyogo, Japan
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Kobe-shi, Hyogo, Japan
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Nishinomiya, Hyogo, Japan
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Takarazuka-shi, Hyogo, Japan
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Higashiibaragi-gun, Ibaragi, Japan
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Sashima-gun, Ibaragi, Japan
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Hakusan-shi, Ishikawa, Japan
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Kanazawa, Ishikawa, Japan
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Kanazawa-shi, Ishikawa, Japan
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Sakaide-shi, Kagawa, Japan
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Atsugi-shi, Kanagawa, Japan
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Isehara, Kanagawa, Japan
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Kamakura-shi, Kanagawa, Japan
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Kawasaki-shi, Kanagawa, Japan
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Sagamihara-shi, Kanagawa, Japan
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Yamato-shi, Kanagawa, Japan
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Yokohama-shi, Kanagawa, Japan
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Nankoku-shi, Kochi, Japan
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Kumamoto-shi, Kumamoto, Japan
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Yatsushiro-city, Kumamoto, Japan
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Kyoto-shi, Kyoto, Japan
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Sendai-shi, Miyagi, Japan
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Azumino-shi, Nagano, Japan
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Ueda-shi, Nagano, Japan
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Nagasaki-shi, Nagasaki, Japan
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Kurashiki, Okayama, Japan
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Okayama-shi, Okayama, Japan
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Hirakata, Osaka, Japan
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Kawachinagano-shi, Osaka, Japan
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Osaka-shi, Osaka, Japan
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Sakai-shi, Osaka, Japan
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Saga-shi, Saga, Japan
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Ageo-shi, Saitama, Japan
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Hidaka, Saitama, Japan
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Sayama-shi, Saitama, Japan
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Kusatsu-shi, Shiga, Japan
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Moriyama, Shiga, Japan
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Matsue, Shimane, Japan
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Hamamatsu-shi, Shizuoka, Japan
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Izunokuni, Shizuoka, Japan
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Shimada-shi, Shizuoka, Japan
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Sunto-gun, Shizuoka, Japan
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Komatsushima-shi, Tokushima, Japan
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Tokushima-shi, Tokushima, Japan
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Adachi-ku, Tokyo, Japan
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Bunkyo, Tokyo, Japan
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Bunkyo-ku, Tokyo, Japan
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Chiyoda-ku, Tokyo, Japan
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Itabashi-ku, Tokyo, Japan
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Meguro, Tokyo, Japan
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Ome-shi, Tokyo, Japan
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Shinagawa-ku, Tokyo, Japan
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Shinjuku, Tokyo, Japan
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Suginami-ku, Tokyo, Japan
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Tanabe-shi, Wakayama, Japan
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Chuo-shi, Yamanashi, Japan
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Fukuoka, Japan
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Gifu, Japan
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Kumamoto, Japan
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Oita, Japan
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Saga, Japan
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Wakayama, Japan
Korea, Republic of
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Cheonan, Chungcheongnam-do, Korea, Republic of
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Daejeon, Korea, Republic of
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Incheon, Korea, Republic of
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Seoul, Korea, Republic of
Taiwan
Research Site
Niao-song-shiang, Kaohsiung, Taiwan
Research Site
Kweishan Shiang, Taoyuan Hsien, Taiwan
Research Site
Taichung, Taiwan
Research Site
Taipei, Taiwan
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Judith Hsia, MD AstraZeneca
  More Information

Additional Information:
No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01294462     History of Changes
Other Study ID Numbers: D5130C00027
Study First Received: February 10, 2011
Results First Received: July 10, 2013
Last Updated: June 18, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Taiwan: Department of Health

Keywords provided by AstraZeneca:
acute coronary syndrome
coronary disease
coronary artery disease

Additional relevant MeSH terms:
Acute Coronary Syndrome
Syndrome
Angina Pectoris
Cardiovascular Diseases
Chest Pain
Disease
Heart Diseases
Myocardial Ischemia
Pain
Pathologic Processes
Signs and Symptoms
Vascular Diseases
Aspirin
Clopidogrel
Ticagrelor
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antipyretics
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Fibrin Modulating Agents
Fibrinolytic Agents
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents

ClinicalTrials.gov processed this record on November 20, 2014