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)

Study Overview
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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).

Official Title
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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

Conditions
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Acute Coronary Syndrome, Percutaneous Coronary Intervention

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Clopidogrel
* Drug: Acetylsalicylic acid ASA


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Ticagrelor (AZD6140) | Drug: Ticagrelor<br>* 90 mg, oral dose twice daily<br>* Other names: AZD6140;Drug: Acetylsalicylic acid ASA<br>* Low Dose ASA<br>|
| Active Comparator: 2<br>Clopidogrel | Drug: Clopidogrel<br>* 75 mg, oral dose once daily<br>* Other names: Plavix;Drug: Acetylsalicylic acid ASA<br>* Low Dose ASA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute coronary syndrome, coronary disease, coronary artery disease