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Brilinta Taiwan Post Approval Safety Study

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ClinicalTrials.gov Identifier: NCT02406248
Recruitment Status : Completed
First Posted : April 2, 2015
Results First Posted : October 15, 2018
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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

Condition or disease Intervention/treatment Phase
Non ST-elevation Myocardial Infarction Drug: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) Phase 4

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  (Clinical Trial)
Actual Enrollment : 108 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 23, 2015
Actual Primary Completion Date : February 9, 2017
Actual Study Completion Date : February 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Ticagrelor

Arm Intervention/treatment
Experimental: single arm
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Drug: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Other Name: "Brilinta"




Primary Outcome Measures :
  1. Number of Participants With Fatal/Life-threatening Bleedings [ Time Frame: during 1year follow up with ticagrelor treatment ]
    Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings

  2. Number of Participants With Bleeding Events (Major Bleedings) [ Time Frame: during 1year follow up with ticagrelor treatment ]
    Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings

  3. Number of Participants With Bleeding Events (Major and Minor Bleedings) [ Time Frame: during 1year follow up with ticagrelor treatment ]
    Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings

  4. Number of Participants With Other Serious Adverse Event (SAEs) [ Time Frame: during 1year follow up with ticagrelor treatment ]
    Evaluation of serious adverse events other than bleedings

  5. Number of Participants With Major Cardiovascular Events [ Time Frame: during 1year follow up with ticagrelor treatment ]
    Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke



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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406248


Locations
Taiwan
Research Site
Changhua City, Taiwan, 50006
Research Site
Hsinchu, Taiwan, 300
Research Site
Kaohsiung, Taiwan, 80756
Research Site
Kaohsiung, Taiwan, 81362
Research Site
Niao-Song-Shiang, Taiwan, 833
Research Site
Taichung, Taiwan
Research Site
Tainan County, Taiwan
Research Site
Tainan, Taiwan, 704
Research Site
Taipei, Taiwan, 104
Research Site
Taipei, Taiwan, 11101
Research Site
Taipei, Taiwan, 11217
Research Site
Taipei, Taiwan, 11220
Research Site
Taipei, Taiwan, 22060
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Chun-peng Liu, Ph.D Kaohsiung Veterans General Hospital.
  Study Documents (Full-Text)

Documents provided by AstraZeneca:

Additional Information:
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02406248     History of Changes
Other Study ID Numbers: D5130C00103
First Posted: April 2, 2015    Key Record Dates
Results First Posted: October 15, 2018
Last Update Posted: October 15, 2018
Last Verified: October 2018

Keywords provided by AstraZeneca:
NSTEMI

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Non-ST Elevated Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs