A Phase IV Study of the Onset and Maintenance of the Antiplatelet Effect of Ticagrelor Compared With Clopidogrel in Chinese Patients With ACS (HouYi)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01864005
First received: May 24, 2013
Last updated: April 28, 2015
Last verified: April 2015
Results First Received: February 17, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Non-ST or ST Elevation Acute Coronary Syndromes
Interventions: Drug: Ticagrelor
Drug: Clopidogrel

  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
First subject enrolled: 15/05/2013, Last subject last visit: 18/03/2014. There were 5 study centers in China, which participated this study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was no run-in or any other pre-assignment periods following participant enrollment.

Reporting Groups
  Description
Ticagrelor Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
Clopidogrel Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.

Participant Flow:   Overall Study
    Ticagrelor     Clopidogrel  
STARTED     29     31  
COMPLETED     26     25  
NOT COMPLETED     3     6  
Protocol Violation                 0                 1  
Withdrawal by Subject                 0                 1  
Incorrect enrolment                 1                 0  
Disease need                 1                 1  
Need GP IIb/IIIa                 1                 3  



  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.
Three randomized patients were excluded from the full analysis set (FAS) due to any of the following reasons: 1) did not meet exclusion requirments but was randomized, 2)post-treatment blood PRU was not available, 3) pre-treatment blood PRU was missing, and 4) use of prohibited medications.

Reporting Groups
  Description
Ticagrelor Patients received a loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor was given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 90mg of ticagrelor orally bd. The total study period was 6 weeks.
Clopidogrel Patients received a loading dose of 600mg clopidogrel tablets (eight 75mg tablets) taken orally. The second dose of clopidogrel had been given to patients after the blood sample had been obtained 24 hours after the first dose. Thereafter, the patients took 75mg of clopidogrel orally od. The total study period was 6 weeks.
Total Total of all reporting groups

Baseline Measures
    Ticagrelor     Clopidogrel     Total  
Number of Participants  
[units: participants]
  28     29     57  
Age  
[units: years]
Mean (Standard Deviation)
  58.75  (10.967)     58.59  (9.789)     58.67  (10.291)  
Gender  
[units: Participants]
     
Female     2     8     10  
Male     26     21     47  
Race (NIH/OMB)  
[units: Participants]
     
American Indian or Alaska Native     0     0     0  
Asian     28     29     57  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     0     0     0  
White     0     0     0  
More than one race     0     0     0  
Unknown or Not Reported     0     0     0  



  Outcome Measures
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1.  Primary:   the Percentage Inhibition of the P2Y12 Receptor   [ Time Frame: at 2 hours after first dose of study drug ]

2.  Secondary:   the Percentage Inhibition of the P2Y12 Receptor   [ Time Frame: at 0.5 hour after first dose of study drug ]

3.  Secondary:   the Percentage Inhibition of the P2Y12 Receptor   [ Time Frame: at 8 hours after first dose of study drug ]

4.  Secondary:   the Percentage Inhibition of the P2Y12 Receptor   [ Time Frame: at 24 hours after first dose of study drug ]

5.  Secondary:   the Percentage Inhibition of the P2Y12 Receptor   [ Time Frame: at 6 weeks after first dose of study drug ]


  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
(1) Sample size was relatively small. (2) Study duration with 6 weeks seemed limited. (3) Sampling time-points seemed relatively scarce, such as missing the time point for 1-hour and 4-hour after loading dose.


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Judith Hsia
Organization: Astrazeneca
phone: 1-301-398-0102
e-mail: judithhsia@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01864005     History of Changes
Other Study ID Numbers: D5130L00053
Study First Received: May 24, 2013
Results First Received: February 17, 2015
Last Updated: April 28, 2015
Health Authority: China: Food and Drug Administration