We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Brilinta DaYu Study (DaYu)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01870921
First Posted: June 6, 2013
Last Update Posted: February 9, 2017
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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

Condition Intervention Phase
Acute Coronary Syndrome Drug: Ticagrelor Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • Major CV Events [ Time Frame: 12 months ]
    Combination of CV death, MI, and stroke


Enrollment: 2004
Study Start Date: June 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ticargrelor
90 mg/tablet, 1 tablet bid
Drug: Ticagrelor
90mg/tablet, 1 tablet bid

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 130 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01870921


Locations
China
Research Site
Beijing, China
Research Site
Changchun, China
Research Site
Chengdu, China
Research Site
Chuangchun, China
Research Site
Fuzhou, China
Research Site
Guangzhou, China
Research Site
Jinan, China
Research Site
Jining, China
Research Site
Kunming, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Shenyang, China
Research Site
Shenzhen, China
Research Site
Taiyuan, China
Research Site
Wuhan, China
Research Site
Wuxi, China
Research Site
Xiamen, China
Research Site
Xian, China
Research Site
Xuzhou, China
Research Site
Zhengzhou, China
Research Site
Zhongshan, China
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Runlin Gao, Doctor Fu Wai Hospital, Beijing, China
  More Information

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01870921     History of Changes
Other Study ID Numbers: D5130C00087
First Submitted: June 4, 2013
First Posted: June 6, 2013
Results First Submitted: September 22, 2016
Results First Posted: November 9, 2016
Last Update Posted: February 9, 2017
Last Verified: December 2016

Additional relevant MeSH terms:
Syndrome
Acute Coronary Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs