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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
  Purpose

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.


Condition
Acute Coronary Syndromes

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta

Resource links provided by NLM:

MedlinePlus related topics: Angina Heart Attack
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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


Estimated Enrollment: 3500
Study Start Date: December 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients who take Brilinta according to the local approval condition

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01611272

Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: JooWon Lee AstraZeneca Korea
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01611272     History of Changes
Other Study ID Numbers: D5130L00019
Study First Received: May 25, 2012
Last Updated: December 3, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Unstable angina

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Angina Pectoris
 Vascular Diseases
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 22, 2013