A Pharmacodynamic Study With Ticagrelor in Hispanic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01523366
First received: January 30, 2012
Last updated: August 14, 2014
Last verified: August 2014
Results First Received: May 10, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Stable Coronary Artery Disease
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
Patients recruited from 6 centers in the United States from April 2012 until May 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
53 patients screened; 40 patients randomized; 38 patients completed the study (7, 8, or 9 days of both treatment sequences), and 39 completed follow-up.

Reporting Groups
  Description
Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)

Participant Flow for 3 periods

Period 1:   Treatment Period 1
    Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence     Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence  
STARTED     20     20  
COMPLETED     19     20  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  

Period 2:   Washout Period - 10-14 Days
    Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence     Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence  
STARTED     19     20  
COMPLETED     19     20  
NOT COMPLETED     0     0  

Period 3:   Treatment Period 2
    Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence     Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence  
STARTED     19     20  
COMPLETED     18     20  
NOT COMPLETED     1     0  
Not completed at least 7 days treatment                 1                 0  



  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.
Randomized Analysis Set for demography (N=40) - included all patients who signed informed consent and were randomized into the study. Pharmacodynamic (PD) Analysis Set for outcomes (N=38) - included all patients for whom PD data was available with no major protocol deviations thought to significantly affect the PD of ticagrelor or clopidogrel

Reporting Groups
  Description
Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence Ticagrelor 180 milligrams (mg) loading dose followed by 90 mg twice daily (bd) for 7,8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg once daily (od) for 7, 8 or 9 days (Period 2).
Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence Clopidogrel 600 mg loading dose followed by 75 mg od for 7, 8 or 9 days (Period 1), then ticagrelor 180 mg loading dose followed by 90 mg bd for 7,8 or 9 days (Period 2)
Total Total of all reporting groups

Baseline Measures
    Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence     Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence     Total  
Number of Participants  
[units: participants]
  20     20     40  
Age, Customized  
[units: Participants]
     
<18 years     0     0     0  
Between 18 and 65 years     10     12     22  
>=65 years     10     8     18  
Gender  
[units: Participants]
     
Female     6     6     12  
Male     14     14     28  
Race/Ethnicity, Customized  
[units: Participants]
     
White     17     18     35  
Not Reported     3     2     5  
Race/Ethnicity, Customized  
[units: Participants]
     
Hispanic or Latino     20     20     40  
Not Reported     0     0     0  
Region of Enrollment  
[units: Participants]
     
United States     20     20     40  
Region of Enrollment  
[units: Participants]
     
United States     20     20     40  



  Outcome Measures
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1.  Primary:   Inhibition of the P2Y12 Receptor as Measured by P2Y12 Reactions Units (PRU) From VerifyNow™ (a Platelet Function Test Developed by Accumetrics) at 2 Hours After Loading Dose   [ Time Frame: At 2 hours after the loading dose ]

2.  Secondary:   Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 0.5 and 8 Hours After Loading Dose   [ Time Frame: At 0.5 and 8 hours after the loading dose ]

3.  Secondary:   Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 and 8 Hours on Day 7 After Multiple Doses and at End of Dosing Interval on Day 8   [ Time Frame: At 2 hours and 8 hours on Day 7 after multiple doses, and at the end of dosing interval on Day 8 ]

4.  Secondary:   Ticagrelor Plasma Concentrations After the Loading and Maintenance Doses   [ Time Frame: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose ]

5.  Secondary:   AR-C124910XX (an Active Metabolite of Ticagrelor) Plasma Concentrations After the Loading and Maintenance Doses   [ Time Frame: Predose, 0.5, 2, 8 hours from loading dose; 0, 2, 8 and 12 hours from last dose ]


  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
Total N for the secondary outcome analysis after multiple doses and for PK measures was not the same for 2 hours, 8 hours and end of dosing. Only the first time point total N can be reported via the form. Row titles indicate N's where they differ.


  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: Tomas LG Andersson, MD, PhD
Organization: AstraZeneca
phone: 1-800-236-9933
e-mail: ClinicalTrialTransparency@astrazeneca.com


No publications provided


Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01523366     History of Changes
Other Study ID Numbers: D5130L00012
Study First Received: January 30, 2012
Results First Received: May 10, 2014
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration