Overview

This trial is active, not recruiting.

Condition non st-elevation myocardial infarction
Treatment ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
Phase phase 4
Sponsor AstraZeneca
Start date April 2015
End date February 2017
Trial size 100 participants
Trial identifier NCT02406248, D5130C00103

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd) "Brilinta"
Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)

Primary Outcomes

Measure
The fatal/life-threatening bleedings
time frame: during 1year follow up with ticagrelor treatment
The bleeding events (major bleedings)
time frame: during 1year follow up with ticagrelor treatment
The bleeding events (major and minor bleedings)
time frame: during 1year follow up with ticagrelor treatment
Other Serious adverse event (SAEs)
time frame: during 1year follow up with ticagrelor treatment
Major cardiovascular events
time frame: during 1year follow up with ticagrelor treatment

Eligibility Criteria

Male or female participants at least 20 years old.

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

Additional Information

Official title 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
Principal investigator Chun-peng Liu, Ph.D
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by AstraZeneca.