Brilinta DaYu Study

Phase 4

Completed

• Conditions: Acute Coronary Syndrome
• Interventions: Drug: Ticagrelor

• Registration Number: NCT01870921
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-04
• Study First Submitted QC: 2013-06-05
• Study First Posted: 2013-06-06
• Study Start: 2013-06-26
• Primary Completion: 2015-09-30
• Study Completion: 2015-09-30
• Results First Submitted: 2016-09-22
• Results First Submitted QC: 2016-09-22
• Results First Posted: 2016-11-09
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-07
• Last Update Posted: 2018-04-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2004

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ticargrelor	Ticagrelor	90 mg/tablet, 1 tablet bid

Primary Outcome Measures

Name	Time	Method
Bleeding Events	12 months	PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
Serious Adverse Events Other Than Bleeding	12 months	SAEs except the blending events which have aleady been reported as SAEs.

Secondary Outcome Measures

Name	Time	Method
Major CV Events	12 months	Combination of CV death, MI, and stroke

Trial Locations

Locations (1)

Research Site; 🇨🇳 Zhongshan, China