This trial is active, not recruiting.

Condition acute coronary syndromes
Sponsor AstraZeneca
Start date April 2013
End date April 2016
Trial size 3500 participants
Trial identifier NCT01611272, D5130L00019


To identify the following items through the post marketing surveillance under routine clinical practice after marketing authorization of Brilinta Tablet: the occurrence of unrevealed Serious Adverse Events (SAEs), current status of occurrence of Adverse Events (AEs), the factors that may influence safety and efficacy of the drug.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Unstable angina, Non ST-segment Elevation Myocardial Infarction or ST-segment elevation myocardial infarction including patients managed medically, and those who are managed with percutaneous coronary intervention or coronary artery by-pass grafting

Primary Outcomes

Number of Hemorrhage events
time frame: up to 54 months
Number of other AEs
time frame: up to 54 months

Secondary Outcomes

Number of Stroke events
time frame: up to 54 months
Number of Cardiovascular (CV) related deaths events
time frame: up to 54 months
Number of Myocardial Infarction events
time frame: up to 54 months

Eligibility Criteria

Male or female participants from 19 years up to 130 years old.

Inclusion Criteria: - Patients with Acute Coronary Syndromes - Patients who are taking ticagrelor and ASA daily(75-150mg), or Patients who are taking ticagrelor only(In the case that the patients have contraindication with ASA. Contraindication should be recorded in accordance with local PI on CRFs) - Patients who have signed the Data release consent form prior to enrollment in this surveillance Exclusion Criteria: - Patients with hypersensitivity to ingredients of this drug or with moderate or severe hepatic impairment or with medical history of intracranial hemorrhage - Patients with pathological hemorrhage at the time of administration - Patients being administrated strong CYP3A4 inhibitors

Additional Information

Official title A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
Description A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.