Brilinta Taiwan Post Approval Safety Study

AstraZeneca108 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

108

Conditions

Non ST-elevation Myocardial Infarction

Interventions

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)

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (13)

Research Site

Changhua, Taiwan

Research Site

Hsinchu, Taiwan

Research Site

Kaohsiung City, Taiwan

Research Site

Kaohsiung City, Taiwan

Outcomes

Primary Outcomes

Number of Participants With Fatal/Life-threatening Bleedings

Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings