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OpenTrials
Completed

NCT Number: NCT02406248

Brilinta Taiwan Post Approval Safety Study

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

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Key information

Conditions

Non ST-elevation Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Non-ST Elevated Myocardial Infarction Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site, Changhua, Taiwan

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

Other names: "Brilinta"

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Apr 2, 2015
Registry last updated
Oct 15, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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