Acute Coronary Syndrome, Old Myocardial Infarction
Conditions
Brief summary
To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg or 90 mg (hereinafter referred to as BRILINTA) in clinical practice in the post-marketing phase. 1. Profile and incidence of ADRs The CEI will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc. 2. Profile and incidence of ADRs not expected from Precautions for Use of the ticagrelor JPI 3. Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke) 4. Factors which may affect safety or efficacy of ticagrelor
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
16 Years to 130 Years
Healthy volunteers
No
Inclusion criteria
* Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.
Exclusion criteria
\-
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse event incidence | from baseline to 4 years |
| Incidence of ADRs not expected from Precautions for Use of the ticagrelor JPI | from baseline to 4 years |
| Incidence of cardiovascular events | from baseline to 4 years |
| Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment | from baseline to 4 years |
| Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment | from baseline to 4 years |
Countries
Japan
Outcome results
None listed