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)

Acute Coronary Syndrome Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01294462
• Other study ID #: D5130C00027
• Status: Completed
• Phase: Phase 3
• First received: February 10, 2011
• Last updated: June 18, 2014
• Start date: February 2011
• Est. completion date: July 2012

Study information

• Verified date: May 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Pharmaceuticals and Medical Devices AgencyKorea: Food and Drug AdministrationTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 801
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Percutaneous Coronary Intervention
• Syndrome

Intervention

Drug:
• Ticagrelor
90 mg, oral dose twice daily
• Clopidogrel
75 mg, oral dose once daily
• Acetylsalicylic acid ASA
Low Dose ASA

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Japan,  Korea, Republic of,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	No
Secondary	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.	Ongoing up to12 months	Yes
Secondary	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.	Ongoing up to 12 months	No

External Links

•   CSR-D5130C00027.pdf