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Brilinta DaYu Study (DaYu)

Primary Purpose

Acute Coronary Syndrome

Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Ticagrelor
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Coronary Syndrome

Eligibility Criteria

18 Years - 130 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ticargrelor

Arm Description

90 mg/tablet, 1 tablet bid

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Major CV Events
Combination of CV death, MI, and stroke

Full Information

First Posted
June 4, 2013
Last Updated
March 7, 2018
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01870921
Brief Title
Brilinta DaYu Study
Acronym
DaYu
Official Title
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(ACS)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
June 26, 2013 (Actual)
Primary Completion Date
September 30, 2015 (Actual)
Study Completion Date
September 30, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Coronary Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2004 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ticargrelor
Arm Type
Experimental
Arm Description
90 mg/tablet, 1 tablet bid
Intervention Type
Drug
Intervention Name(s)
Ticagrelor
Intervention Description
90mg/tablet, 1 tablet bid
Primary Outcome Measure Information:
Title
Bleeding Events
Description
PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
Time Frame
12 months
Title
Serious Adverse Events Other Than Bleeding
Description
SAEs except the blending events which have aleady been reported as SAEs.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Major CV Events
Description
Combination of CV death, MI, and stroke
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Runlin Gao, Doctor
Organizational Affiliation
Fu Wai Hospital, Beijing, China
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100006
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100083
Country
China
Facility Name
Research Site
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Research Site
City
Changchun
ZIP/Postal Code
130021
Country
China
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Research Site
City
Chuangchun
ZIP/Postal Code
130041
Country
China
Facility Name
Research Site
City
Fuzhou
ZIP/Postal Code
350001
Country
China
Facility Name
Research Site
City
Fuzhou
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510080
Country
China
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510220
Country
China
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250012
Country
China
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250021
Country
China
Facility Name
Research Site
City
Jinan
ZIP/Postal Code
250033
Country
China
Facility Name
Research Site
City
Jining
ZIP/Postal Code
272011
Country
China
Facility Name
Research Site
City
Kunming
ZIP/Postal Code
650032
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210009
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210012
Country
China
Facility Name
Research Site
City
Nanjing
ZIP/Postal Code
210029
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200025
Country
China
Facility Name
Research Site
City
Shanghai
ZIP/Postal Code
200433
Country
China
Facility Name
Research Site
City
Shanghai
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110001
Country
China
Facility Name
Research Site
City
Shenyang
ZIP/Postal Code
110016
Country
China
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518003
Country
China
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518020
Country
China
Facility Name
Research Site
City
Shenzhen
ZIP/Postal Code
518036
Country
China
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Facility Name
Research Site
City
Wuhan
ZIP/Postal Code
CN-430022
Country
China
Facility Name
Research Site
City
Wuxi
ZIP/Postal Code
214023
Country
China
Facility Name
Research Site
City
Xiamen
ZIP/Postal Code
361004
Country
China
Facility Name
Research Site
City
Xian
ZIP/Postal Code
710032
Country
China
Facility Name
Research Site
City
Xian
ZIP/Postal Code
710061
Country
China
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221006
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450000
Country
China
Facility Name
Research Site
City
Zhengzhou
ZIP/Postal Code
450012
Country
China
Facility Name
Research Site
City
Zhongshan
ZIP/Postal Code
528403
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
29488142
Citation
Gao R, Wu Y, Liu H, Su G, Yuan Z, Zhang A, Wang Y, Wang Z, Wang Y, Zhang H, Zheng Y, Liu L, Shen L, Leonsson-Zachrisson M, Han Y; DAYU study investigators. Safety and Incidence of Cardiovascular Events in Chinese Patients with Acute Coronary Syndrome Treated with Ticagrelor: the 12-Month, Phase IV, Multicenter, Single-Arm DAYU Study. Cardiovasc Drugs Ther. 2018 Feb;32(1):47-56. doi: 10.1007/s10557-018-6772-3.
Results Reference
background
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=1829&filename=D5130C00087%20_Clinical%20StudyProtocol_and_amendment_redacted.pdf
Description
D5130C00087 Clinical Study Protocol and amendment redacted

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Brilinta DaYu Study

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