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Brilinta DaYu Study (DaYu)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01870921
First received: June 4, 2013
Last updated: December 19, 2016
Last verified: December 2016

June 4, 2013
December 19, 2016
June 2013
September 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 ClinicalTrials.gov 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
Not Provided
Not Provided
 
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
Interventional
Phase 4
Intervention Model: Single Group Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2004
September 2015
September 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, Senior)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01870921
D5130C00087
Not Provided
Not Provided
Not Provided
Not Provided
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Runlin Gao, Doctor Fu Wai Hospital, Beijing, China
AstraZeneca
December 2016

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