NCT01611272

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,402

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2013

Typical duration for all trials

Geographic Reach
1 country

23 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 4, 2012

Completed
11 months until next milestone

Study Start

First participant enrolled

April 30, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2016

Completed
Last Updated

July 13, 2017

Status Verified

July 1, 2017

Enrollment Period

3.2 years

First QC Date

May 25, 2012

Last Update Submit

July 11, 2017

Conditions

Acute Coronary Syndromes

Keywords

Unstable angina

Outcome Measures

Primary Outcomes (2)

  • Number of Hemorrhage events

    up to 54 months

  • Number of other AEs

    up to 54 months

Secondary Outcomes (3)

  • Number of Stroke events

    up to 54 months

  • Number of Cardiovascular (CV) related deaths events

    up to 54 months

  • Number of Myocardial Infarction events

    up to 54 months

Study Arms (1)

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

Eligibility Criteria

Age19 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who take Brilinta according to the local approval condition

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

Research Site

Cheonan-si, Chungcheongnam-do, South Korea

Location

Research Site

Chuncheon, Gangwon-do, South Korea

Location

Research Site

Wŏnju, Gangwon-do, South Korea

Location

Research Site

Ansan-si, Gyeonggi-do, South Korea

Location

Research Site

Anyang-si, Gyeonggi-do, South Korea

Location

Research Site

Bucheon-si, Gyeonggi-do, South Korea

Location

Research Site

Goyang-si, Gyeonggi-do, South Korea

Location

Research Site

Koyang-shi, Gyeonggi-do, South Korea

Location

Research Site

Seongnam-si, Gyeonggi-do, South Korea

Location

Research Site

Suwon, Gyeonggi-do, South Korea

Location

Research Site

Andong, Gyeongsangbuk-do, South Korea

Location

Research Site

Gumi, Gyeongsangbuk-do, South Korea

Location

Research Site

Gimhae, Gyeongsangnam-do, South Korea

Location

Research Site

Iksan-si, Jeollabuk-do, South Korea

Location

Research Site

Jeonju, Jeollabuk-do, South Korea

Location

Research Site

Suncheon-si, Jeollanam-do, South Korea

Location

Research Site

Busan, South Korea

Location

Research Site

Daegu, South Korea

Location

Research Site

Daejeon, South Korea

Location

Research Site

Gwangju, South Korea

Location

Research Site

Incheon, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Ulsan, South Korea

Location

Related Links

MeSH Terms

Conditions

Acute Coronary SyndromeAngina, Unstable

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesAngina PectorisChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • JooWon Lee

    AstraZeneca Korea

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2012

First Posted

June 4, 2012

Study Start

April 30, 2013

Primary Completion

July 20, 2016

Study Completion

July 20, 2016

Last Updated

July 13, 2017

Record last verified: 2017-07

Locations

KR(23)