Clinical trial NCT01294462: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Percutaneous Coronary Intervention
Keywords: acute coronary syndrome
coronary disease
coronary artery disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-02-11
Enrollment: 801
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Major Bleeding
timeFrame: Ongoing up to12 months
measure: Major Adverse Cardiac Events (MACE)
timeFrame: Ongoing up to 12 months
Secondary outcomes:
measure: Major and Minor Bleeding
timeFrame: Ongoing up to12 months
measure: Composite of All-cause Mortality, MI or Stroke
timeFrame: Ongoing up to 12 months
Other outcomes:
Locations:
city: Ichinomiya-shi
country: Japan
facility: Research Site
state: Aichi
city: Nagoya-shi
country: Japan
facility: Research Site
state: Aichi
city: Okazaki-shi
country: Japan
facility: Research Site
state: Aichi
city: Toyohashi-shi
country: Japan
facility: Research Site
state: Aichi
city: Toyota-shi
country: Japan
facility: Research Site
state: Aichi
city: Akita-shi
country: Japan
facility: Research Site
state: Akita
city: Ichihara-shi
country: Japan
facility: Research Site
state: Chiba
city: Kamogawa-shi
country: Japan
facility: Research Site
state: Chiba
city: Kisarazu-shi
country: Japan
facility: Research Site
state: Chiba
city: Matsuyama
country: Japan
facility: Research Site
state: Ehime
city: Fukui-shi
country: Japan
facility: Research Site
state: Fukui
city: Fukuoka-shi
country: Japan
facility: Research Site
state: Fukuoka
city: Kasuya-gun
country: Japan
facility: Research Site
state: Fukuoka
city: Kurume
country: Japan
facility: Research Site
state: Fukuoka
city: Gifu-shi
country: Japan
facility: Research Site
state: Gifu
city: Isesaki
country: Japan
facility: Research Site
state: Gunma
city: Maebashi
country: Japan
facility: Research Site
state: Gunma
city: Takasaki-shi
country: Japan
facility: Research Site
state: Gunma
city: Kure
country: Japan
facility: Research Site
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Akashi-shi
country: Japan
facility: Research Site
state: Hyogo
city: Amagasaki-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kawanishi-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe-shi
country: Japan
facility: Research Site
state: Hyogo
city: Kobe
country: Japan
facility: Research Site
state: Hyogo
city: Nishinomiya
country: Japan
facility: Research Site
state: Hyogo
city: Takarazuka-shi
country: Japan
facility: Research Site
state: Hyogo
city: Higashiibaragi-gun
country: Japan
facility: Research Site
state: Ibaragi
city: Sashima-gun
country: Japan
facility: Research Site
state: Ibaragi
city: Hakusan-shi
country: Japan
facility: Research Site
state: Ishikawa
city: Kanazawa-shi
country: Japan
facility: Research Site
state: Ishikawa
city: Kanazawa
country: Japan
facility: Research Site
state: Ishikawa
city: Sakaide-shi
country: Japan
facility: Research Site
state: Kagawa
city: Atsugi-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Isehara
country: Japan
facility: Research Site
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yamato-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Research Site
state: Kanagawa
city: Nankoku-shi
country: Japan
facility: Research Site
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Research Site
state: Kumamoto
city: Yatsushiro-city
country: Japan
facility: Research Site
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Research Site
state: Kyoto
city: Sendai-shi
country: Japan
facility: Research Site
state: Miyagi
city: Azumino-shi
country: Japan
facility: Research Site
state: Nagano
city: Ueda-shi
country: Japan
facility: Research Site
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Research Site
state: Nagasaki
city: Kurashiki
country: Japan
facility: Research Site
state: Okayama
city: Okayama-shi
country: Japan
facility: Research Site
state: Okayama
city: Hirakata
country: Japan
facility: Research Site
state: Osaka
city: Kawachinagano-shi
country: Japan
facility: Research Site
state: Osaka
city: Osaka-shi
country: Japan
facility: Research Site
state: Osaka
city: Sakai-shi
country: Japan
facility: Research Site
state: Osaka
city: Saga-shi
country: Japan
facility: Research Site
state: Saga
city: Ageo-shi
country: Japan
facility: Research Site
state: Saitama
city: Hidaka
country: Japan
facility: Research Site
state: Saitama
city: Sayama-shi
country: Japan
facility: Research Site
state: Saitama
city: Kusatsu-shi
country: Japan
facility: Research Site
state: Shiga
city: Moriyama
country: Japan
facility: Research Site
state: Shiga
city: Matsue
country: Japan
facility: Research Site
state: Shimane
city: Hamamatsu-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Izunokuni
country: Japan
facility: Research Site
state: Shizuoka
city: Shimada-shi
country: Japan
facility: Research Site
state: Shizuoka
city: Sunto-gun
country: Japan
facility: Research Site
state: Shizuoka
city: Komatsushima-shi
country: Japan
facility: Research Site
state: Tokushima
city: Tokushima-shi
country: Japan
facility: Research Site
state: Tokushima
city: Adachi-ku
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Research Site
state: Tokyo
city: Bunkyo
country: Japan
facility: Research Site
state: Tokyo
city: Chiyoda-ku
country: Japan
facility: Research Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Research Site
state: Tokyo
city: Meguro
country: Japan
facility: Research Site
state: Tokyo
city: Ome-shi
country: Japan
facility: Research Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Research Site
state: Tokyo
city: Shinjuku
country: Japan
facility: Research Site
state: Tokyo
city: Suginami-ku
country: Japan
facility: Research Site
state: Tokyo
city: Tanabe-shi
country: Japan
facility: Research Site
state: Wakayama
city: Chuo-shi
country: Japan
facility: Research Site
state: Yamanashi
city: Fukuoka
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Cheonan
country: Korea, Republic of
facility: Research Site
state: Chungcheongnam-do
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Niao-song-shiang
country: Taiwan
facility: Research Site
state: Kaohsiung
city: Kweishan Shiang
country: Taiwan
facility: Research Site
state: Taoyuan Hsien
city: Taichung
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Judith Hsia, MD
role: STUDY_DIRECTOR
References: