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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: September 22, 2016
Last verified: September 2016
Results First Received: September 22, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Coronary Syndrome
Intervention: Drug: Ticagrelor

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ticargrelor 90 mg/tablet, 1 tablet bid

Participant Flow:   Overall Study
    Ticargrelor
STARTED   2001 
COMPLETED   1651 
NOT COMPLETED   350 
Subject decision                187 
Adverse Event other than death                93 
Severe non-compliance to protocol                29 
Condition under investigation worsened                3 
Development of study-spec. disc. crit.                11 
Other                25 
Lost to Follow-up                2 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Based on the safety population, i.e. all enrolled patients who received at least one dose of Investigational product (IP)

Reporting Groups
  Description
Ticargrelor 90 mg/tablet, 1 tablet bid

Baseline Measures
   Ticargrelor 
Overall Participants Analyzed 
[Units: Participants]
 2001 
Age 
[Units: Years]
Mean (Standard Deviation)
 59.3  (10.83) 
Age, Customized 
[Units: Participants]
 
< 75 years   1854 
>= 75 years   147 
Gender 
[Units: Participants]
 
Female   422 
Male   1579 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
Hispanic or latino   0 
Not hispanic or latino   2001 
[1] Ethnic Group
Race/Ethnicity, Customized [1] 
[Units: Participants]
 
Asian   2001 
Other   0 
[1] Race


  Outcome Measures
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1.  Primary:   Bleeding Events   [ Time Frame: 12 months ]

2.  Primary:   Serious Adverse Events Other Than Bleeding   [ Time Frame: 12 months ]

3.  Secondary:   Major CV Events   [ Time Frame: 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Global Clinical Leader
Organization: AstraZeneca AB
phone: +46 31 7761000
e-mail: ClinicalTrialTransparency@astrazeneca.com



Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01870921     History of Changes
Other Study ID Numbers: D5130C00087
Study First Received: June 4, 2013
Results First Received: September 22, 2016
Last Updated: September 22, 2016
Health Authority: Institution of Beijing Fuwai Hospital, China':'