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
Overview
- Phase
- Phase 4
- Intervention
- Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
- Conditions
- Non ST-elevation Myocardial Infarction
- Sponsor
- AstraZeneca
- Enrollment
- 108
- Locations
- 1
- Primary Endpoint
- Number of Participants With Bleeding Events (Major Bleedings)
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
single arm
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Intervention: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Outcomes
Primary Outcomes
Number of Participants With Bleeding Events (Major Bleedings)
Time Frame: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings
Number of Participants With Fatal/Life-threatening Bleedings
Time Frame: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings
Number of Participants With Bleeding Events (Major and Minor Bleedings)
Time Frame: during 1year follow up with ticagrelor treatment
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings
Number of Participants With Other Serious Adverse Event (SAEs)
Time Frame: during 1year follow up with ticagrelor treatment
Evaluation of serious adverse events other than bleedings
Number of Participants With Major Cardiovascular Events
Time Frame: during 1year follow up with ticagrelor treatment
Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke