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 Elevation Myocardial Infarction

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 108 (actual)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Non ST-elevation Myocardial Infarction

Interventions

Type	Name	Description
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)

Timeline

• Start date: 2015-04-23
• Primary completion: 2017-02-09
• Completion: 2017-02-09
• First posted: 2015-04-02
• Last updated: 2018-10-15
• Results posted: 2018-10-15

Locations

13 sites across 1 country: Taiwan