Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

A Pharmacodynamic Study With Ticagrelor in African American Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01523392
First received: January 30, 2012
Last updated: September 30, 2014
Last verified: September 2014
Results First Received: September 22, 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
  Hide Participant Flow

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 8 participating centers in the United States from 28 March 2012 until 04 September 2013

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
50 patients screened; 34 patients randomized; 30 patients completed the study (7, 8, or 9 days of both treatments), and 31 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), and 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     14  
COMPLETED     17     14  
NOT COMPLETED     3     0  
Withdrawal by Subject                 2                 0  
Did not complete 7-9 days of treatment.                 1                 0  

Period 2:   Washout Period - 10 to 14 Days
    Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence     Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence  
STARTED     18 [1]   14  
COMPLETED     17     14  
NOT COMPLETED     1     0  
Adverse Event                 1                 0  
[1] 1 patient did not complete 7-9 days of Period 1 treatment but continued in the Washout and Period 2

Period 3:   Treatment Period 2
    Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence     Clopidogrel (Period 1) Then Ticagrelor (Period 2) Sequence  
STARTED     17     14  
COMPLETED     17     14  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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=34) - included all patients who signed informed consent and were randomized into the study.

Reporting Groups
  Description
Ticagrelor (Period 1) Then Clopidogrel (Period 2) Sequence Ticagrelor 180 mg loading dose followed by 90 mg bd for 7, 8 or 9 days (Period 1), and then clopidogrel 600 mg loading dose followed by 75 mg 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), and 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     14     34  
Age, Customized  
[units: Participants]
     
<18 years     0     0     0  
>=18 to <65 years     12     10     22  
>= 65 years     8     4     12  
Gender  
[units: Participants]
     
Female     8     3     11  
Male     12     11     23  
Race/Ethnicity, Customized  
[units: Participants]
     
Black or African American     20     14     34  
Race/Ethnicity, Customized  
[units: Participants]
     
Not Hispanic or Latino     20     14     34  
Region of Enrollment  
[units: Participants]
     
United States     20     14     34  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Inhibition of the P2Y12 Receptor as Measured by Platelet Reaction Unit (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 Hour and 8 Hours After Loading Dose   [ Time Frame: At 0.5 hour and 8 hours after the loading dose ]

3.  Secondary:   Inhibition of the P2Y12 Receptor as Measured by PRU From VerifyNow™ at 2 Hours 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 end of dosing interval on Day 8 ]

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


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

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: NCT01523392     History of Changes
Other Study ID Numbers: D5130L00013
Study First Received: January 30, 2012
Results First Received: September 22, 2014
Last Updated: September 30, 2014
Health Authority: United States: Food and Drug Administration