Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management

Study Overview
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Brief Summary
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The purpose of this study is to assess safety and efficacy of Ticagrelor versus Clopidogrel in Asian/KOREAn patients with acute coronary syndromes intended for invasive management.

Official Title
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A Randomized, Open-label, Parallel Group, Multicenter Phase IV Study to Assess Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management:TICAKOREA Trial

Conditions
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Acute Coronary Syndrome, Myocardial Ischemia, Heart Diseases, Cardiovascular Diseases, Angina Pectoris

Intervention / Treatment
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* Drug: Ticagrelor
* Drug: Clopidogrel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 and more Index event of non-ST or ST segment elevation ACS Provision of signed informed consent Exclusion Criteria: Hypersensitivity to aspirin or ticagrelor Oral anticoagulation therapy that cannot be stopped Treated with thrombolysis within 24hrs Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers Any life-threatening condition with life expectancy less than 6months Mental condition (dementia, alcohol or drug abuse) which may be affect study compliance or prevent understanding of the aims, investigational procedures or possible consequences of the study High risk due to malignant hypertension The conditions associated with increased risk of bradycardiac events Subjects with severe liver disease Subjects requiring dialysis Increased bleeding risk History of cerebral hemorrhage, gastrointestinal bleeding within 6months, major surgical procedure within 30days Thrombocytopenia or leukopenia Positive pregnancy test or is known to be pregnant

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ticagrelor<br> | Drug: Ticagrelor<br>* 180mg loading and 90mg bid<br>|
| Active Comparator: Clopidogrel<br> | Drug: Clopidogrel<br>* 600mg loading and 75mg qd<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to first occurrence of any bleeding event | Safety of Ticagrelor compared to Clopidogrel by measuring the time to first occurrence of any bleeding event(including major, minor bleedings) | 1year | 
| The time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke | Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of any event from the composite of death from vascular causes, Myocardial Infarction (MI) and stroke | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to first occurrence of major bleeding event | by PLAtelet inhibition and patient Outcomes(PLATO) criteria | 1year | 
| The time to first occurrence of minor bleeding event | by PLAtelet inhibition and patient Outcomes(PLATO) criteria | 1year | 
| The time to first occurrence of major bleeding event or minor bleeding event | The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria | 1year | 
| The time to first occurrence of major bleeding event | The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria | 1year | 
| The time to first occurrence of minor bleeding event | The Thrombolysis in Myocardial Infarction (TIMI) bleeding criteria | 1year | 
| The time to first occurrence of Bleeding Academic Research Consortium (BARC) bleeding event from type 1 to type 5 | By Bleeding Academic Research Consortium(BARC) Definition of Bleeding Events | 1year | 
| The time of first occurrence of discontinuation of study medication from any bleeding event |  | 1year | 
| Non serious adverse events |  | 1year | 
| Adverse events following discontinuation of study medication |  | 1year | 
| Serious adverse events |  | 1year | 
| The time to first occurrence of death from vascular causes | Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of death from vascular causes | 1year | 
| The time to first occurrence of myocardial infarction | Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of myocardial infarction | 1year | 
| The time to first occurrence of stroke | Effect of Ticagrelor compared to Clopidogrel by measuring: time to first occurrence of stroke | 1year | 
| The time to occurrence of composite events | The time to occurrence of composite events(death from any cause, myocardial infarction, stroke) | 1year | 
| The time to occurrence of death from any cause |  | 1year | 
| Number of patients with net clinical benefit of any total bleeding and any event from the composite of death from vascular causes, Myocardial Infarction and stroke. |  | 1year | 

 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