Brilinta DaYu Study
DaYu
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)
1 other identifier
interventional
2,004
1 country
39
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jun 2013
Typical duration for phase_4
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2013
CompletedFirst Posted
Study publicly available on registry
June 6, 2013
CompletedStudy Start
First participant enrolled
June 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2015
CompletedResults Posted
Study results publicly available
November 9, 2016
CompletedApril 3, 2018
March 1, 2018
2.3 years
June 4, 2013
September 22, 2016
March 7, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Bleeding Events
PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
12 months
Serious Adverse Events Other Than Bleeding
SAEs except the blending events which have aleady been reported as SAEs.
12 months
Secondary Outcomes (1)
Major CV Events
12 months
Study Arms (1)
Ticargrelor
EXPERIMENTAL90 mg/tablet, 1 tablet bid
Interventions
Eligibility Criteria
You may qualify if:
- \. 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
You may not qualify if:
- \. 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (39)
Research Site
Beijing, 100006, China
Research Site
Beijing, 100029, China
Research Site
Beijing, 100037, China
Research Site
Beijing, 100050, China
Research Site
Beijing, 100083, China
Research Site
Beijing, 100730, China
Research Site
Changchun, 130021, China
Research Site
Chengdu, 610041, China
Research Site
Chuangchun, 130041, China
Research Site
Fuzhou, 350001, China
Research Site
Fuzhou, China
Research Site
Guangzhou, 510080, China
Research Site
Guangzhou, 510220, China
Research Site
Jinan, 250012, China
Research Site
Jinan, 250021, China
Research Site
Jinan, 250033, China
Research Site
Jining, 272011, China
Research Site
Kunming, 650032, China
Research Site
Nanjing, 210009, China
Research Site
Nanjing, 210012, China
Research Site
Nanjing, 210029, China
Research Site
Shanghai, 200025, China
Research Site
Shanghai, 200433, China
Research Site
Shanghai, China
Research Site
Shenyang, 110001, China
Research Site
Shenyang, 110016, China
Research Site
Shenzhen, 518003, China
Research Site
Shenzhen, 518020, China
Research Site
Shenzhen, 518036, China
Research Site
Taiyuan, 030001, China
Research Site
Wuhan, CN-430022, China
Research Site
Wuxi, 214023, China
Research Site
Xi'an, 710032, China
Research Site
Xi'an, 710061, China
Research Site
Xiamen, 361004, China
Research Site
Xuzhou, 221006, China
Research Site
Zhengzhou, 450000, China
Research Site
Zhengzhou, 450012, China
Research Site
Zhongshan, 528403, China
Related Publications (1)
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.
PMID: 29488142BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Clinical Leader
- Organization
- AstraZeneca AB
Study Officials
- PRINCIPAL INVESTIGATOR
Runlin Gao, Doctor
Fu Wai Hospital, Beijing, China
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2013
First Posted
June 6, 2013
Study Start
June 26, 2013
Primary Completion
September 30, 2015
Study Completion
September 30, 2015
Last Updated
April 3, 2018
Results First Posted
November 9, 2016
Record last verified: 2018-03