- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02406248
Brilinta Taiwan Post Approval Safety Study
October 12, 2018 updated by: AstraZeneca
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
108
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Changhua City, Taiwan, 50006
- Research Site
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Hsinchu, Taiwan, 300
- Research Site
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Kaohsiung, Taiwan, 80756
- Research Site
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Kaohsiung, Taiwan, 81362
- Research Site
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Niao-Song-Shiang, Taiwan, 833
- Research Site
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Taichung, Taiwan
- Research Site
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Tainan, Taiwan, 704
- Research Site
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Tainan County, Taiwan
- Research Site
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Taipei, Taiwan, 11217
- Research Site
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Taipei, Taiwan, 11101
- Research Site
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Taipei, Taiwan, 104
- Research Site
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Taipei, Taiwan, 11220
- Research Site
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Taipei, Taiwan, 22060
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: single arm
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
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Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Fatal/Life-threatening Bleedings
Time Frame: during 1year follow up with ticagrelor treatment
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Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings
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during 1year follow up with ticagrelor treatment
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Number of Participants With Bleeding Events (Major Bleedings)
Time Frame: during 1year follow up with ticagrelor treatment
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Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings
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during 1year follow up with ticagrelor treatment
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Number of Participants With Bleeding Events (Major and Minor Bleedings)
Time Frame: during 1year follow up with ticagrelor treatment
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Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings
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during 1year follow up with ticagrelor treatment
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Number of Participants With Other Serious Adverse Event (SAEs)
Time Frame: during 1year follow up with ticagrelor treatment
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Evaluation of serious adverse events other than bleedings
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during 1year follow up with ticagrelor treatment
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Number of Participants With Major Cardiovascular Events
Time Frame: during 1year follow up with ticagrelor treatment
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Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke
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during 1year follow up with ticagrelor treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Chun-peng Liu, Ph.D, Kaohsiung Veterans General Hospital.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 23, 2015
Primary Completion (Actual)
February 9, 2017
Study Completion (Actual)
February 9, 2017
Study Registration Dates
First Submitted
March 19, 2015
First Submitted That Met QC Criteria
March 30, 2015
First Posted (Estimate)
April 2, 2015
Study Record Updates
Last Update Posted (Actual)
October 15, 2018
Last Update Submitted That Met QC Criteria
October 12, 2018
Last Verified
October 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Myocardial Infarction
- Infarction
- Non-ST Elevated Myocardial Infarction
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Platelet Aggregation Inhibitors
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Ticagrelor
Other Study ID Numbers
- D5130C00103
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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