Status:
COMPLETED
Brilinta DaYu Study
Lead Sponsor:
AstraZeneca
Conditions:
Acute Coronary Syndrome
Eligibility:
All Genders
18-130 years
Phase:
PHASE4
Brief Summary
A multicenter, single arm, open label, Phase IV study to evaluate safety and to describe the incidence of major cardiovascular events of ticagrelor in Chinese patients with acute coronary syndrome
Eligibility Criteria
Inclusion
- 1\. Female or male aged at least 18 years 2.Index event of non-ST or ST segment elevation ACS 3.A patient who is considered as ethnic Chinese
Exclusion
- 1\. With coagulation disorder 2.Index event is an acute complication of PCI 3.Patient has planned for an urgent coronary artery bypass graft (CABG) within 7days from the enrolment 4.Oral anticoagulation therapy within 30 days prior to enrolment or cannot be stopped 5.Increased risk of bradycardic events 6. Concomitant oral or intravenous therapy (see examples below) with strong CYP3A inhibitors, CYP3A substrates with narrow therapeutic indices, or strong CYP3A inducers 7.Increased risk of bradycardic events (eg, no pacemaker and known sick sinus syndrome, second degree A-V block, third degree A-V block or previous documented syncope suspected to be due to bradycardia unless treated with a pacemaker). 8.Known clinically important thrombocytopenia 9.Known clinically important anaemia
Key Trial Info
Start Date :
June 26 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 30 2015
Estimated Enrollment :
2004 Patients enrolled
Trial Details
Trial ID
NCT01870921
Start Date
June 26 2013
End Date
September 30 2015
Last Update
April 3 2018
Active Locations (39)
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1
Research Site
Beijing, China, 100006
2
Research Site
Beijing, China, 100029
3
Research Site
Beijing, China, 100037
4
Research Site
Beijing, China, 100050