Brilinta DaYu Study (DaYu)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01870921
Recruitment Status : Completed
First Posted : June 6, 2013
Results First Posted : November 9, 2016
Last Update Posted : April 3, 2018
Information provided by (Responsible Party):

June 4, 2013
June 6, 2013
September 22, 2016
November 9, 2016
April 3, 2018
June 26, 2013
September 30, 2015   (Final data collection date for primary outcome measure)
  • Bleeding Events [ Time Frame: 12 months ]
    PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal
  • Serious Adverse Events Other Than Bleeding [ Time Frame: 12 months ]
    SAEs except the blending events which have aleady been reported as SAEs.
  • Cardiovascular(CV) death [ Time Frame: 12 months ]
    The total number of CV death event will be recorded
  • Myocardial infarction (MI) [ Time Frame: 12 months ]
    The total number of MI event will be recorded
Complete list of historical versions of study NCT01870921 on Archive Site
Major CV Events [ Time Frame: 12 months ]
Combination of CV death, MI, and stroke
total major bleed [ Time Frame: 12 months ]
The total number of major bleeding event will be recorded
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Brilinta DaYu Study
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)
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
Not Provided
Phase 4
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Coronary Syndrome
Drug: Ticagrelor
90mg/tablet, 1 tablet bid
Experimental: Ticargrelor
90 mg/tablet, 1 tablet bid
Intervention: Drug: Ticagrelor
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
September 30, 2015
September 30, 2015   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 130 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Principal Investigator: Runlin Gao, Doctor Fu Wai Hospital, Beijing, China
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP