A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
Completed
- Conditions
- Acute Coronary Syndromes
- Registration Number
- NCT01611272
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 3402
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of other AEs up to 54 months Number of Hemorrhage events up to 54 months
- Secondary Outcome Measures
Name Time Method Number of Stroke events up to 54 months for efficacy
Number of Myocardial Infarction events up to 54 months for efficacy
Number of Cardiovascular (CV) related deaths events up to 54 months for efficacy
Trial Locations
- Locations (1)
Research Site
🇰🇷Ulsan, Korea, Republic of