Brilinta Taiwan Post Approval Safety Study

Phase 4

Completed

• Conditions: Non ST-elevation Myocardial Infarction
• Interventions: Drug: Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)

• Registration Number: NCT02406248
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2015-03-19
• Study First Submitted QC: 2015-03-30
• Study First Posted: 2015-04-02
• Study Start: 2015-04-23
• Primary Completion: 2017-02-09
• Study Completion: 2017-02-09
• Results First Submitted: 2018-02-08
• Status Verified: 2018-10
• Results First Submitted QC: 2018-10-12
• Last Update Submitted: 2018-10-12
• Results First Posted: 2018-10-15
• Last Update Posted: 2018-10-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm	Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)	Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Fatal/Life-threatening Bleedings	during 1year follow up with ticagrelor treatment	Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined fatal/life-threatening bleedings
Number of Participants With Bleeding Events (Major Bleedings)	during 1year follow up with ticagrelor treatment	Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major bleedings
Number of Participants With Bleeding Events (Major and Minor Bleedings)	during 1year follow up with ticagrelor treatment	Evaluation of PLATO (PLATelet inhibition and patient Outcomes)-defined major + minor bleedings
Number of Participants With Other Serious Adverse Event (SAEs)	during 1year follow up with ticagrelor treatment	Evaluation of serious adverse events other than bleedings
Number of Participants With Major Cardiovascular Events	during 1year follow up with ticagrelor treatment	Evaluation of major cardiovascular events including cardiovascular death, myocardial infarction or stroke

Trial Locations

Locations (1)

Research Site; 🇨🇳 Taipei, Taiwan