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

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.

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndromes

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 3402

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Research Site
  • Daegu, Korea, Republic of
    • Research Site
  • Daejeon, Korea, Republic of
    • Research Site
  • Gwangju, Korea, Republic of
    • Research Site
  • Incheon, Korea, Republic of
    • Research Site
  • Seoul, Korea, Republic of
    • Research Site
  • Ulsan, Korea, Republic of
    • Research Site
  • Chungcheongnam-do
    • Cheonan-si, Chungcheongnam-do, Korea, Republic of
      • Research Site
  • Gangwon-do
    • Chuncheon-si, Gangwon-do, Korea, Republic of
      • Research Site
  • Gyeonggi-do
    • Ansan-Si, Gyeonggi-do, Korea, Republic of
      • Research Site
    • Anyang-si, Gyeonggi-do, Korea, Republic of
      • Research Site
    • Bucheon-si, Gyeonggi-do, Korea, Republic of
      • Research Site
    • Goyang-si, Gyeonggi-do, Korea, Republic of
      • Research Site
    • Koyang-shi, Gyeonggi-do, Korea, Republic of
      • Research Site
    • Seongnam-si, Gyeonggi-do, Korea, Republic of
      • Research Site
    • Suwon-si, Gyeonggi-do, Korea, Republic of
      • Research Site
  • Gyeongsangbuk-do
    • Andong-si, Gyeongsangbuk-do, Korea, Republic of
      • Research Site
    • Gumi-si, Gyeongsangbuk-do, Korea, Republic of
      • Research Site
  • Gyeongsangnam-do
    • Gimhae-si, Gyeongsangnam-do, Korea, Republic of
      • Research Site
  • Jeollabuk-do
    • Iksan-si, Jeollabuk-do, Korea, Republic of
      • Research Site
    • Jeonju-si, Jeollabuk-do, Korea, Republic of
      • Research Site
  • Jeollanam-do
    • Suncheon-si, Jeollanam-do, Korea, Republic of
      • Research Site
  • Kangwon-do
    • Wonju-si, Kangwon-do, Korea, Republic of
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 130 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients who take Brilinta according to the local approval condition

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of Hemorrhage events	up to 54 months
Number of other AEs	up to 54 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Stroke events	for efficacy	up to 54 months
Number of Cardiovascular (CV) related deaths events	for efficacy	up to 54 months
Number of Myocardial Infarction events	for efficacy	up to 54 months

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: JooWon Lee, AstraZeneca Korea

Publications and helpful links

Helpful Links

• CSR Synopsis

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 30, 2013
• Primary Completion (ACTUAL): July 20, 2016
• Study Completion (ACTUAL): July 20, 2016

Study Registration Dates

• First Submitted: May 25, 2012
• First Submitted That Met QC Criteria: May 31, 2012
• First Posted (ESTIMATE): June 4, 2012

Study Record Updates

• Last Update Posted (ACTUAL): July 13, 2017
• Last Update Submitted That Met QC Criteria: July 11, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Unstable angina
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: D5130L00019