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

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02406248

Enrollment

108

Registered

2015-04-02

Start date

2015-04-23

Completion date

2017-02-09

Last updated

2018-10-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non ST-elevation Myocardial Infarction

Keywords

NSTEMI

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.

Interventions

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

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Taiwan

Participant flow

Recruitment details

This study was conducted at 13 centres in Taiwan. The first patient was enrolled on 23 April 2015 and the last visit of the last patient took was on 9 February 2017. Informed consent was received for 113 patients

Pre-assignment details

Out of the patients who provided informed consent 95.6 % (n=108) of the patients received study drug. 8 patients provided informed consent but did not fulfill eligibility criteria, out of whom 5 did not receive treatment and 3 received treatment.

Participants by arm

Arm	Count
Single Arm Ticagrelor 90mg twice daily (bd)	108
Total	108

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Death	7
Overall Study	Withdrawal by Subject	2

Baseline characteristics

Characteristic	Single Arm
Age, Continuous	61.7 years STANDARD_DEVIATION 12.12
Race/Ethnicity, Customized Asian	108 Participants
Race/Ethnicity, Customized Not hispanic or latino	108 Participants
Sex: Female, Male Female	22 Participants
Sex: Female, Male Male	86 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	7 / 108
other Total, other adverse events	45 / 108
serious Total, serious adverse events	23 / 108