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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01611272

Enrollment

3402

Registered

2012-06-04

Start date

2013-04-30

Completion date

2016-07-20

Last updated

2017-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Coronary Syndromes

Keywords

Unstable angina

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.

Detailed description

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to 130 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of Hemorrhage events	up to 54 months
Number of other AEs	up to 54 months

Secondary

Measure	Time frame	Description
Number of Stroke events	up to 54 months	for efficacy
Number of Cardiovascular (CV) related deaths events	up to 54 months	for efficacy
Number of Myocardial Infarction events	up to 54 months	for efficacy

Countries

South Korea

Outcome results