Brilinta DaYu Study

AstraZeneca

Status and phase

Completed

Phase 4

Conditions

Acute Coronary Syndrome

Treatments

Drug: Ticagrelor

Study type

Interventional

Funder types

Industry

Identifiers

NCT01870921

D5130C00087

Details and patient eligibility

About

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

Enrollment

2,004 patients

Sex

All

Ages

18 to 130 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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