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)

NCT ID: NCT01294462

Last Updated: 2014-06-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

801 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2012-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Acute Coronary Syndrome Percutaneous Coronary Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Ticagrelor (AZD6140)

Group Type EXPERIMENTAL

Ticagrelor

Intervention Type DRUG

90 mg, oral dose twice daily

Acetylsalicylic acid ASA

Intervention Type DRUG

Low Dose ASA

2

Clopidogrel

Group Type ACTIVE_COMPARATOR

Clopidogrel

Intervention Type DRUG

75 mg, oral dose once daily

Acetylsalicylic acid ASA

Intervention Type DRUG

Low Dose ASA

Interventions

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Ticagrelor

90 mg, oral dose twice daily

Intervention Type DRUG

Clopidogrel

75 mg, oral dose once daily

Intervention Type DRUG

Acetylsalicylic acid ASA

Low Dose ASA

Intervention Type DRUG

Other Intervention Names

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AZD6140 Plavix

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Judith Hsia, MD

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Ichinomiya-shi, Aichi-ken, Japan

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Nagoya, Aichi-ken, Japan

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Okazaki-shi, Aichi-ken, Japan

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Toyohashi, Aichi-ken, Japan

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Toyota-shi, Aichi-ken, Japan

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Akita, 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, Fukuoka, Japan

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Kasuya-gun, Fukuoka, Japan

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Kurume, Fukuoka, Japan

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Gifu, 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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Akashi-shi, Hyōgo, Japan

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Amagasaki-shi, Hyōgo, Japan

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Kawanishi-shi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Nishinomiya, Hyōgo, Japan

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Takarazuka-shi, Hyōgo, Japan

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Higashiibaragi-gun, Ibaragi, Japan

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Sashima-gun, Ibaragi, Japan

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Hakusan-shi, Ishikawa-ken, Japan

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Kanazawa, Ishikawa-ken, Japan

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Sakaide-shi, Kagawa-ken, 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, Kanagawa, Japan

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Nankoku-shi, Kochi, Japan

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Kumamoto, Kumamoto, Japan

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Yatsushiro, Kumamoto, Japan

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Kyoto, Kyoto, Japan

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Sendai, Miyagi, Japan

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Azumino-shi, Nagano, Japan

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Ueda-shi, Nagano, Japan

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Nagasaki, Nagasaki, Japan

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Ōita, Oita Prefecture, Japan

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Kurashiki, Okayama-ken, Japan

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Okayama, Okayama-ken, Japan

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Hirakata, Osaka, Japan

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Kawachinagano-shi, Osaka, Japan

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Osaka, Osaka, Japan

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Sakai-shi, Osaka, Japan

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Saga, Saga-ken, 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, 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, Tokushima, Japan

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Adachi-ku, Tokyo, Japan

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Bunkyo-ku, Tokyo, Japan

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Bunkyo, Tokyo, Japan

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Chiyoda-ku, Tokyo, Japan

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Itabashi-ku, Tokyo, Japan

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Meguro City, 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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Wakayama, Wakayama, Japan

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Chuo-shi, Yamanashi, Japan

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Cheonan, Chungcheongnam-do, South Korea

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Daejeon, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Niao-song-shiang, Kaohsiung, Taiwan

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Kweishan Shiang, Taoyuan Hsien, Taiwan

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Taichung, , Taiwan

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Taipei, , Taiwan

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Countries

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Japan South Korea Taiwan

Related Links

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Other Identifiers

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D5130C00027

Identifier Type: -

Identifier Source: org_study_id

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