A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta

AstraZeneca

Status: Completed

Conditions: Acute Coronary Syndromes

Study type: Observational

Funder types: Industry

Identifiers

NCT01611272

D5130L00019

Details and patient eligibility

About

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.

Full description

A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta

Enrollment: 3,402 patients

Sex: All

Ages: 19 to 130 years old

Volunteers: No Healthy Volunteers

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

Trial design

3,402 participants in 1 patient group

1

Description:

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