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)

AstraZeneca801 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

801

Conditions

Acute Coronary Syndrome Percutaneous Coronary Intervention

Interventions

TicagrelorDRUG

90 mg, oral dose twice daily

ClopidogrelDRUG

75 mg, oral dose once daily

Acetylsalicylic acid ASADRUG

Low Dose ASA

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (87)

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Ongoing up to 12 months

Secondary Outcomes

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.

Time frame: Ongoing up to12 months

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.

Time frame: Ongoing up to 12 months

Data from ClinicalTrials.gov

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Research Site

Ichinomiya-shi, Aichi-ken, Japan

Research Site

Nagoya, Aichi-ken, Japan

Research Site

Okazaki-shi, Aichi-ken, Japan

Research Site

Toyohashi, Aichi-ken, Japan

Research Site

Toyota-shi, Aichi-ken, Japan

Research Site

Akita, Akita, Japan

Research Site

Ichihara-shi, Chiba, Japan

Research Site

Kamogawa-shi, Chiba, Japan

Research Site

Kisarazu-shi, Chiba, Japan

Research Site

Matsuyama, Ehime, Japan

...and 77 more locations