Brilinta Taiwan Post Approval Safety Study

Non ST-elevation Myocardial Infarction Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02406248
• Other study ID #: D5130C00103
• Status: Completed
• Phase: Phase 4
• Start date: April 23, 2015
• Est. completion date: February 9, 2017

Study information

• Verified date: October 2018
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 9, 2017
• Est. primary completion date: February 9, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• Non ST-elevation Myocardial Infarction
• Non-ST Elevated Myocardial Infarction

Intervention

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)

Locations

Country	Name	City	State
Taiwan	Research Site	Changhua City
Taiwan	Research Site	Hsinchu
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Niao-Song-Shiang
Taiwan	Research Site	Taichung
Taiwan	Research Site	Tainan
Taiwan	Research Site	Tainan County
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei
Taiwan	Research Site	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome

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

External Links

•   RevisedCSP2D5130C00103Redacted_a