Brilinta Taiwan Post Approval Safety Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-23

Study Completion Date

2017-02-09

Brief Summary

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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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Detailed Description

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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.

Conditions

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Non ST-elevation Myocardial Infarction

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single arm

Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)

Group Type EXPERIMENTAL

Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)

Intervention Type DRUG

Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)

Interventions

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Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)

Intervention Type DRUG

Other Intervention Names

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"Brilinta"

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No