Clinical trial NCT02406248: Brilinta Taiwan Post Approval Safety Study
Official title: A Multicenter, Single Arm, Open Label, Phase IV Study to Evaluate Safety and to Describe the Cumulative Incidence of Major Cardiovascular Events of Ticagrelor in Taiwanese Patients With Non ST-segment Elevation Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non ST-elevation Myocardial Infarction
Keywords: NSTEMI
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2015-04-02
Enrollment: 108
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the cumulative incidence of major cardiovascular events of Ticagrelor in Taiwanese patients with non ST-segment (a segment in the eletrocardiogram which presents the period when ventricles are depolarized) elevation myocardial infarction

Detailed description: This study will be conducted in approximately 8 investigational centres in Taiwan. It is expected that approximately 100 patients will be enrolled into study treatment. This study is to describe the safety and tolerability of ticagrelor, by assessment of the bleeding events and other serious adverse events (SAEs) during 1year follow up in Taiwanese non ST-elevation myocardial infarction (NSTEMI) patients.

Eligibility criteria: Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures
2. Female or male aged at least 20 years
3. Patient who is considered as ethnic Taiwanese
4. Index event of non-ST elevation myocardial infarction

Exclusion Criteria:

1. Contraindication or other reason that ticagrelor should not be administered
2. Index event is an acute complication of Percutaneous coronary intervention (PCI)
3. Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment
4. Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped
5. Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment

Primary outcomes:
measure: Number of Participants With Fatal/Life-threatening Bleedings
timeFrame: during 1year follow up with ticagrelor treatment
measure: Number of Participants With Bleeding Events (Major Bleedings)
timeFrame: during 1year follow up with ticagrelor treatment
measure: Number of Participants With Bleeding Events (Major and Minor Bleedings)
timeFrame: during 1year follow up with ticagrelor treatment
measure: Number of Participants With Other Serious Adverse Event (SAEs)
timeFrame: during 1year follow up with ticagrelor treatment
measure: Number of Participants With Major Cardiovascular Events
timeFrame: during 1year follow up with ticagrelor treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Changhua City
country: Taiwan
facility: Research Site
city: Hsinchu
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Kaohsiung
country: Taiwan
facility: Research Site
city: Niao-Song-Shiang
country: Taiwan
facility: Research Site
city: Taichung
country: Taiwan
facility: Research Site
city: Tainan County
country: Taiwan
facility: Research Site
city: Tainan
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
Study officials:
affiliation: Kaohsiung Veterans General Hospital.
name: Chun-peng Liu, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: