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

Acute Coronary Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01611272
• Other study ID #: D5130L00019
• Status: Completed
• Phase: N/A
• First received: May 25, 2012
• Last updated: July 11, 2017
• Start date: April 30, 2013
• Est. completion date: July 20, 2016

Study information

• Verified date: July 2017
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3402
• Est. completion date: July 20, 2016
• Est. primary completion date: July 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 130 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Andong-si	Gyeongsangbuk-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	Busan
Korea, Republic of	Research Site	Cheonan-si	Chungcheongnam-do
Korea, Republic of	Research Site	Chuncheon-si	Gangwon-do
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Daejeon
Korea, Republic of	Research Site	Gimhae-si	Gyeongsangnam-do
Korea, Republic of	Research Site	Goyang-si	Gyeonggi-do
Korea, Republic of	Research Site	Gumi-si	Gyeongsangbuk-do
Korea, Republic of	Research Site	Gwangju
Korea, Republic of	Research Site	Iksan-si	Jeollabuk-do
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeonju-si	Jeollabuk-do
Korea, Republic of	Research Site	Koyang-shi	Gyeonggi-do
Korea, Republic of	Research Site	Seongnam-si	Gyeonggi-do
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Suncheon-si	Jeollanam-do
Korea, Republic of	Research Site	Suwon-si	Gyeonggi-do
Korea, Republic of	Research Site	Ulsan
Korea, Republic of	Research Site	Wonju-si	Kangwon-do

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Hemorrhage events		up to 54 months
Primary	Number of other AEs		up to 54 months
Secondary	Number of Stroke events	for efficacy	up to 54 months
Secondary	Number of Cardiovascular (CV) related deaths events	for efficacy	up to 54 months
Secondary	Number of Myocardial Infarction events	for efficacy	up to 54 months

External Links

•   CSR Synopsis