Clinical trial NCT03212287: Brilinta Clinical Experience Investigation
Official title: Brilinta Tablets 60mg/90mg Clinical Experience Investigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome, Old Myocardial Infarction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2017-07-11
Enrollment: 663
Sex: ALL
Minimum age (years): 16
Maximum age (years): 130
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.

Brief summary: To confirm the following safety topics in patients to be treated with BRILINTA tablets 60 mg or 90 mg (hereinafter referred to as "BRILINTA") in clinical practice in the post-marketing phase.

1. Profile and incidence of ADRs The CEI will be conducted to collect data of the events, especially focusing on bleeding, dyspnoea and bradyarrhythmia so as to investigate onset, outcome, treatment for the event, and risk factors for these events, etc.
2. Profile and incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
3. Efficacy: Profile and incidence of cardiovascular events (cardiovascular death, non-fatal myocardial infarction and non-fatal ischemic stroke)
4. Factors which may affect safety or efficacy of ticagrelor


Eligibility criteria: Inclusion Criteria:

* Patients treated with BRILINTA for ACS or OMI, which is the indication of the drug.

Exclusion Criteria:

-

Primary outcomes:
measure: Adverse event incidence
timeFrame: from baseline to 4 years
measure: Incidence of ADRs not expected from "Precautions for Use" of the ticagrelor JPI
timeFrame: from baseline to 4 years
measure: Incidence of cardiovascular events
timeFrame: from baseline to 4 years
measure: Factors which may affect incidence of bleeding, dyspnoea, bradyarrhythmia, analysed by patient demographic characteristic and by treatment
timeFrame: from baseline to 4 years
measure: Factors which may affect incidence of cardiovascular events, analysed by patient demographic characteristic and by treatment
timeFrame: from baseline to 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Aichi
country: Japan
facility: Research Site
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
References: