Safety and Efficacy of Ticagrelor Versus Clopidogrel in Asian/KOREAn Patients With Acute Coronary Syndromes Intended for Invasive Management
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
Inclusion Criteria
- Index event of non-ST or ST segment elevation ACS
- Provision of signed informed consent
- Age 18 and more
- Index event of non-ST or ST segment elevation ACS
- Provision of signed informed consent
- Age 18 and more
Exclusion Criteria
- Treated with thrombolysis within 24hrs
- Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
- Thrombocytopenia or leukopenia
- ...
- Treated with thrombolysis within 24hrs
- Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
- Thrombocytopenia or leukopenia
- The conditions associated with increased risk of bradycardiac events
- Subjects requiring dialysis
- Increased bleeding risk
- Positive pregnancy test or is known to be pregnant
- Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers
- High risk due to malignant hypertension
- History of cerebral hemorrhage, gastrointestinal bleeding within 6months, major surgical procedure within 30days
- Oral anticoagulation therapy that cannot be stopped
- 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
- Subjects with severe liver disease
- Any life-threatening condition with life expectancy less than 6months
- Hypersensitivity to aspirin or ticagrelor
Summary
- Conditions
- Acute Coronary Syndrome
- Angina Pectoris
- Cardiovascular Diseases
- Heart Diseases
- Myocardial Ischemia
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Inclusion Criteria
- Index event of non-ST or ST segment elevation ACS
- Provision of signed informed consent
- Age 18 and more
- Index event of non-ST or ST segment elevation ACS
- Provision of signed informed consent
- Age 18 and more
Exclusion Criteria
- Treated with thrombolysis within 24hrs
- Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
- Thrombocytopenia or leukopenia
- ...
- Treated with thrombolysis within 24hrs
- Any other reason the investigator deems the subject to be unsuitable for the study e.g., Active malignant tumor
- Thrombocytopenia or leukopenia
- The conditions associated with increased risk of bradycardiac events
- Subjects requiring dialysis
- Increased bleeding risk
- Positive pregnancy test or is known to be pregnant
- Concomitant therapy with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic index, or strong CYP3A inducers
- High risk due to malignant hypertension
- History of cerebral hemorrhage, gastrointestinal bleeding within 6months, major surgical procedure within 30days
- Oral anticoagulation therapy that cannot be stopped
- 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
- Subjects with severe liver disease
- Any life-threatening condition with life expectancy less than 6months
- Hypersensitivity to aspirin or ticagrelor
Tracking Information
- NCT #
- NCT02094963
- Collaborators
- CardioVascular Research Foundation, Korea
- Investigators
- Not Provided
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