Brilinta Taiwan Post Approval Safety Study

AstraZeneca

Status and phase: Completed; Phase 4

Conditions: Non ST-elevation Myocardial Infarction

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT02406248

D5130C00103

Details and patient eligibility

About

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

Full 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.

Enrollment: 108 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

108 participants in 1 patient group

single arm

Experimental group

Description:

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

Treatment:

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