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)

NCT01294462 | Completed Phase 3 Results

• 1 other identifier: D5130C00027
• Study Type: interventional
• Target: 801
• Locations: 3 countries
• Sites: 87

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).

Conditions

Acute Coronary Syndrome; Percutaneous Coronary Intervention

Keywords

acute coronary syndrome; coronary disease; coronary artery disease

Outcome Measures

Primary Outcomes (2)

• 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.

  Ongoing up to12 months

• 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.

  Ongoing up to 12 months

Secondary Outcomes (2)

• Major and Minor Bleeding

  Ongoing up to12 months

• Composite of All-cause Mortality, MI or Stroke

  Ongoing up to 12 months

Study Arms (2)

1

EXPERIMENTAL

Ticagrelor (AZD6140)

Drug: Ticagrelor; Drug: Acetylsalicylic acid ASA

2

ACTIVE COMPARATOR

Clopidogrel

Drug: Clopidogrel; Drug: Acetylsalicylic acid ASA

Interventions

Ticagrelor DRUG

90 mg, oral dose twice daily

Also known as: AZD6140

1

Clopidogrel DRUG

75 mg, oral dose once daily

Also known as: Plavix

2

Acetylsalicylic acid ASA DRUG

Low Dose ASA

1; 2

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provision of signed informed consent
• Index event of non-ST or ST segment elevation ACS

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (87)

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

Location

Related Links

• CSR-D5130C00027.pdf

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Disease; Coronary Artery Disease

Interventions

Ticagrelor; Clopidogrel; Aspirin

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Adenosine; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: Judith Hsia
• Organization: AstraZeneca

ClinicalTrialTransparency@astrazeneca.com

Study Officials

• Judith Hsia, MD

  AstraZeneca

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 11, 2011
• Study Start: February 1, 2011
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: June 27, 2014
• Results First Posted: May 2, 2014

Record last verified: 2014-05

Locations

TW (4); KR (4); JP (79)