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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01611272
First received: May 25, 2012
Last updated: July 29, 2016
Last verified: July 2016
  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:


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


Enrollment: 3402
Study Start Date: April 2013
Study Completion Date: July 2016
Primary Completion Date: July 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 to 130 Years   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Korea, Republic of
Research Site
Cheonan-si, Chungcheongnam-do, Korea, Republic of
Research Site
Chuncheon-si, Gangwon-do, Korea, Republic of
Research Site
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
Andong-si, Gyeongsangbuk-do, Korea, Republic of
Research Site
Gumi-si, Gyeongsangbuk-do, Korea, Republic of
Research Site
Gimhae-si, Gyeongsangnam-do, Korea, Republic of
Research Site
Iksan-si, Jeollabuk-do, Korea, Republic of
Research Site
Jeonju-si, Jeollabuk-do, Korea, Republic of
Research Site
Suncheon-si, Jeollanam-do, Korea, Republic of
Research Site
Wonju-si, Kangwon-do, Korea, Republic of
Research Site
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
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: JooWon Lee AstraZeneca Korea
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01611272     History of Changes
Other Study ID Numbers: D5130L00019 
Study First Received: May 25, 2012
Last Updated: July 29, 2016
Health Authority: Korea: Ministry of Food and Drug Safety
Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Unstable angina

Additional relevant MeSH terms:
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016