Brilinta Clinical Experience Investigation (BRLCEIACS/OMI)

AstraZeneca

Status: Completed

Conditions: Acute Coronary Syndrome, Old Myocardial Infarction

Study type: Observational

Funder types: Industry

Identifiers

NCT03212287

D5133N00007

Details and patient eligibility

About

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

Enrollment: 663 patients

Sex: All

Ages: 16 to 130 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.

Exclusion criteria