Clinical trial NCT01611272: A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
Official title: A Post Marketing Surveillance to Evaluate the Safety and Efficacy of Brilinta
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndromes
Keywords: Unstable angina
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-06-04
Enrollment: 3402
Sex: ALL
Minimum age (years): 19
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who take Brilinta according to the local approval condition

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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Hemorrhage events
timeFrame: up to 54 months
measure: Number of other AEs
timeFrame: up to 54 months
Secondary outcomes:
measure: Number of Stroke events
timeFrame: up to 54 months
measure: Number of Cardiovascular (CV) related deaths events
timeFrame: up to 54 months
measure: Number of Myocardial Infarction events
timeFrame: up to 54 months
Other outcomes:
Locations:
city: Cheonan-si
country: Korea, Republic of
facility: Research Site
state: Chungcheongnam-do
city: Chuncheon-si
country: Korea, Republic of
facility: Research Site
state: Gangwon-do
city: Ansan-Si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Anyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Bucheon-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Koyang-shi
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Andong-si
country: Korea, Republic of
facility: Research Site
state: Gyeongsangbuk-do
city: Gumi-si
country: Korea, Republic of
facility: Research Site
state: Gyeongsangbuk-do
city: Gimhae-si
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Iksan-si
country: Korea, Republic of
facility: Research Site
state: Jeollabuk-do
city: Jeonju-si
country: Korea, Republic of
facility: Research Site
state: Jeollabuk-do
city: Suncheon-si
country: Korea, Republic of
facility: Research Site
state: Jeollanam-do
city: Wonju-si
country: Korea, Republic of
facility: Research Site
state: Kangwon-do
city: Busan
country: Korea, Republic of
facility: Research Site
city: Daegu
country: Korea, Republic of
facility: Research Site
city: Daejeon
country: Korea, Republic of
facility: Research Site
city: Gwangju
country: Korea, Republic of
facility: Research Site
city: Incheon
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Ulsan
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: AstraZeneca Korea
name: JooWon Lee
role: STUDY_DIRECTOR
References: