Brilinta Taiwan Post Approval Safety Study

Study Overview
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Brief Summary
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A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial infarction

Detailed Description
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This study will be conducted in approximately 8 investigational centres in Taiwan. It is expected that approximately 100 patients will be enrolled into study treatment. This study is to describe the safety and tolerability of ticagrelor, by assessment of the bleeding events and other serious adverse events (SAEs) during 1year follow up in Taiwanese non ST-elevation myocardial infarction (NSTEMI) patients.

Official Title
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A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Cumulative Incidence of Major Cardiovascular Events of Ticagrelor in Taiwanese Patients With Non ST-segment Elevation Myocardial Infarction

Conditions
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Non ST-elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provision of informed consent prior to any study specific procedures Female or male aged at least 20 years Patient who is considered as ethnic Taiwanese Index event of non-ST elevation myocardial infarction Exclusion Criteria: Contraindication or other reason that ticagrelor should not be administered Index event is an acute complication of Percutaneous coronary intervention (PCI) Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single arm<br>Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) | Drug: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)<br>* Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)<br>* Other names: Brilinta;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Fatal/Life-threatening Bleedings | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings | during 1year follow up with ticagrelor treatment | 
| Number of Participants With Bleeding Events (Major Bleedings) | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings | during 1year follow up with ticagrelor treatment | 
| Number of Participants With Bleeding Events (Major and Minor Bleedings) | Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings | during 1year follow up with ticagrelor treatment | 
| Number of Participants With Other Serious Adverse Event (SAEs) | Evaluation of serious adverse events other than bleedings | during 1year follow up with ticagrelor treatment | 
| Number of Participants With Major Cardiovascular Events | Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke | during 1year follow up with ticagrelor treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSTEMI