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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.
 
ClinicalTrials.gov Identifier: NCT01870921
Recruitment Status : Completed
First Posted : June 6, 2013
Results First Posted : November 9, 2016
Last Update Posted : April 3, 2018
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Drug: Ticagrelor Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2004 participants
Allocation: N/A
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)
Actual Study Start Date : June 26, 2013
Actual Primary Completion Date : September 30, 2015
Actual Study Completion Date : September 30, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Ticagrelor

Arms and Interventions
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Arm Intervention/treatment
Experimental: Ticargrelor
90 mg/tablet, 1 tablet bid
 Drug: Ticagrelor
90mg/tablet, 1 tablet bid


Outcome Measures
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Primary Outcome Measures :
  1. Bleeding Events [ Time Frame: 12 months ]
    PLATO-defined fatal/life threatening, major, major+minor,major+minor+minimal

  2. 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 :
  1. Major CV Events [ Time Frame: 12 months ]
    Combination of CV death, MI, and stroke


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 130 Years   (Adult, Older Adult)
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
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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
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China
Research Site
Beijing, China, 100006
Research Site
Beijing, China, 100029
Research Site
Beijing, China, 100037
Research Site
Beijing, China, 100050
Research Site
Beijing, China, 100083
Research Site
Beijing, China, 100730
Research Site
Changchun, China, 130021
Research Site
Chengdu, China, 610041
Research Site
Chuangchun, China, 130041
Research Site
Fuzhou, China, 350001
Research Site
Fuzhou, China
Research Site
Guangzhou, China, 510080
Research Site
Guangzhou, China, 510220
Research Site
Jinan, China, 250012
Research Site
Jinan, China, 250021
Research Site
Jinan, China, 250033
Research Site
Jining, China, 272011
Research Site
Kunming, China, 650032
Research Site
Nanjing, China, 210009
Research Site
Nanjing, China, 210012
Research Site
Nanjing, China, 210029
Research Site
Shanghai, China, 200025
Research Site
Shanghai, China, 200433
Research Site
Shanghai, China
Research Site
Shenyang, China, 110001
Research Site
Shenyang, China, 110016
Research Site
Shenzhen, China, 518003
Research Site
Shenzhen, China, 518020
Research Site
Shenzhen, China, 518036
Research Site
Taiyuan, China, 030001
Research Site
Wuhan, China, CN-430022
Research Site
Wuxi, China, 214023
Research Site
Xiamen, China, 361004
Research Site
Xian, China, 710032
Research Site
Xian, China, 710061
Research Site
Xuzhou, China, 221006
Research Site
Zhengzhou, China, 450000
Research Site
Zhengzhou, China, 450012
Research Site
Zhongshan, China, 528403
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Runlin Gao, Doctor Fu Wai Hospital, Beijing, China
More Information
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Additional Information:

Publications:

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01870921    
Other Study ID Numbers: D5130C00087
First Posted: June 6, 2013    Key Record Dates
Results First Posted: November 9, 2016
Last Update Posted: April 3, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Syndrome
Disease
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Ticagrelor
 Platelet Aggregation Inhibitors
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs