Back to resultsBrilinta Taiwan Post Approval Safety Study
Primary Purpose
Non ST-elevation Myocardial Infarction
Status
Completed
Phase
Phase 4
Locations
Taiwan
Study Type
Interventional
Intervention
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Sponsored by
About this trial
This is an interventional treatment trial for Non ST-elevation Myocardial Infarction focused on measuring NSTEMI
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent prior to any study specific procedures
- Female or male aged at least 20 years
- Patient who is considered as ethnic Taiwanese
- Index event of non-ST elevation myocardial infarction
Exclusion Criteria:
- Contraindication or other reason that ticagrelor should not be administered
- Index event is an acute complication of Percutaneous coronary intervention (PCI)
- Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment
- Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped
- Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment
Sites / Locations
- Research Site
- Research Site
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- Research Site
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- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
single arm
Arm Description
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Outcomes
Primary Outcome Measures
Number of Participants With Fatal/Life-threatening Bleedings
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings
Number of Participants With Bleeding Events (Major Bleedings)
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings
Number of Participants With Bleeding Events (Major and Minor Bleedings)
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings
Number of Participants With Other Serious Adverse Event (SAEs)
Evaluation of serious adverse events other than bleedings
Number of Participants With Major Cardiovascular Events
Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02406248
Brief Title
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
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 23, 2015 (Actual)
Primary Completion Date
February 9, 2017 (Actual)
Study Completion Date
February 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non ST-elevation Myocardial Infarction
Keywords
NSTEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single arm
Arm Type
Experimental
Arm Description
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Intervention Type
Drug
Intervention Name(s)
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Other Intervention Name(s)
"Brilinta"
Intervention Description
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Primary Outcome Measure Information:
Title
Number of Participants With Fatal/Life-threatening Bleedings
Description
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings
Time Frame
during 1year follow up with ticagrelor treatment
Title
Number of Participants With Bleeding Events (Major Bleedings)
Description
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings
Time Frame
during 1year follow up with ticagrelor treatment
Title
Number of Participants With Bleeding Events (Major and Minor Bleedings)
Description
Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings
Time Frame
during 1year follow up with ticagrelor treatment
Title
Number of Participants With Other Serious Adverse Event (SAEs)
Description
Evaluation of serious adverse events other than bleedings
Time Frame
during 1year follow up with ticagrelor treatment
Title
Number of Participants With Major Cardiovascular Events
Description
Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke
Time Frame
during 1year follow up with ticagrelor treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent prior to any study specific procedures
Female or male aged at least 20 years
Patient who is considered as ethnic Taiwanese
Index event of non-ST elevation myocardial infarction
Exclusion Criteria:
Contraindication or other reason that ticagrelor should not be administered
Index event is an acute complication of Percutaneous coronary intervention (PCI)
Patient has planned for an urgent coronary artery bypass graft (CABG) within 7 days from the enrolment
Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped
Fibrinolytic therapy in the 24 hours prior to enrolment, or planned fibrinolytic treatment following enrolment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chun-peng Liu, Ph.D
Organizational Affiliation
Kaohsiung Veterans General Hospital.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Changhua City
ZIP/Postal Code
50006
Country
Taiwan
Facility Name
Research Site
City
Hsinchu
ZIP/Postal Code
300
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
81362
Country
Taiwan
Facility Name
Research Site
City
Niao-Song-Shiang
ZIP/Postal Code
833
Country
Taiwan
Facility Name
Research Site
City
Taichung
Country
Taiwan
Facility Name
Research Site
City
Tainan County
Country
Taiwan
Facility Name
Research Site
City
Tainan
ZIP/Postal Code
704
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
104
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11101
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11220
Country
Taiwan
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
22060
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=2611&filename=RevisedCSP2D5130C00103Redacted_a.pdf
Description
RevisedCSP2D5130C00103Redacted_a
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Brilinta Taiwan Post Approval Safety Study
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