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

This study is not yet open for participant recruitment.
Verified December 2012 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01611272
First received: May 25, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes

May 25, 2012
December 3, 2012
December 2013
December 2016   (final data collection date for primary outcome measure)
  • Number of Hemorrhage events [ Time Frame: up to 54 months ] [ Designated as safety issue: Yes ]
  • Number of other AEs [ Time Frame: up to 54 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01611272 on ClinicalTrials.gov Archive Site
  • Number of Stroke events [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
    for efficacy
  • Number of Cardiovascular (CV) related deaths events [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
    for efficacy
  • Number of Myocardial Infarction events [ Time Frame: up to 54 months ] [ Designated as safety issue: No ]
    for efficacy
Same as current
Not Provided
Not Provided
 
A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
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.

A Post Marketing Surveillance to evaluate the safety and efficacy of Brilinta
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample

Patients who take Brilinta according to the local approval condition
Acute Coronary Syndromes
Not Provided
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
3500
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Not Provided
Not Provided
 
NCT01611272
D5130L00019
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Study Director: JooWon Lee AstraZeneca Korea
AstraZeneca
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP