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

NCT ID: NCT01611272

Last Updated: 2017-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3402 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-07-20

Brief Summary

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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.

Detailed Description

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

Conditions

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Acute Coronary Syndromes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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JooWon Lee

Role: STUDY_DIRECTOR

AstraZeneca Korea

Locations

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Research Site

Cheonan-si, Chungcheongnam-do, South Korea

Site Status

Research Site

Chuncheon, Gangwon-do, South Korea

Site Status

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Wŏnju, Gangwon-do, South Korea

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Ansan-si, Gyeonggi-do, South Korea

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Anyang-si, Gyeonggi-do, South Korea

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Bucheon-si, Gyeonggi-do, South Korea

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Goyang-si, Gyeonggi-do, South Korea

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Koyang-shi, Gyeonggi-do, South Korea

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Seongnam-si, Gyeonggi-do, South Korea

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Suwon, Gyeonggi-do, South Korea

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Andong, Gyeongsangbuk-do, South Korea

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Gumi, Gyeongsangbuk-do, South Korea

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Gimhae, Gyeongsangnam-do, South Korea

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Iksan-si, Jeollabuk-do, South Korea

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Jeonju, Jeollabuk-do, South Korea

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Suncheon-si, Jeollanam-do, South Korea

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Busan, , South Korea

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Daegu, , South Korea

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Daejeon, , South Korea

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Gwangju, , South Korea

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Incheon, , South Korea

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Seoul, , South Korea

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Ulsan, , South Korea

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Countries

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South Korea

Related Links

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Other Identifiers

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D5130L00019

Identifier Type: -

Identifier Source: org_study_id

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