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OpenTrials
Completed

NCT Number: NCT01611272

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.

Completed

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Key information

Conditions

Acute Coronary Syndromes Acute Coronary Syndrome Angina Pectoris Angina, Unstable Cardiovascular Diseases Chest Pain Heart Diseases Myocardial Ischemia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

19 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Cheonan-si, Chungcheongnam-do, South Korea

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of Hemorrhage events

    Time frame: up to 54 months

  2. Number of other AEs

    Time frame: up to 54 months

Secondary outcomes

  1. Number of Stroke events

    Time frame: up to 54 months

    for efficacy

  2. Number of Cardiovascular (CV) related deaths events

    Time frame: up to 54 months

    for efficacy

  3. Number of Myocardial Infarction events

    Time frame: up to 54 months

    for efficacy

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Jun 4, 2012
Registry last updated
Jul 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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