Study to Learn When Platelets Return to Normal After One Loading Dose of Anti-platelet Drugs in Patients With Symptoms of Acute Coronary Syndromes

This study has been terminated.
(Terminated due to Enrollment futility)
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01107899
First received: April 19, 2010
Last updated: March 7, 2012
Last verified: March 2012
Results First Received: December 1, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Coronary Syndromes
Interventions: Drug: clopidogrel
Drug: prasugrel

  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
No text entered.

Reporting Groups
  Description
Clopidogrel 600 mg Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])

Participant Flow:   Overall Study
    Clopidogrel 600 mg     Prasugrel 60 mg     Prasugrel 30 mg  
STARTED     10     10     9  
Received at Least One Dose of Study Drug     10     10     8  
Loading Dose (LD) Intent to Treat (ITT)     5 [1]   10 [1]   6 [1]
ITT Washout Population     5 [2]   10 [2]   6 [2]
Primary Washout Population     5 [3]   10 [3]   4 [3]
COMPLETED     5     10     5  
NOT COMPLETED     5     0     4  
Physician Decision                 5                 0                 3  
Withdrawal by Subject                 0                 0                 1  
[1] Received LD and had evaluable pharmacodynamic (PD) measurements 24-hours post-LD.
[2] ITT Washout Population (WP): Received LD, had evaluable baseline PD data (pre-LD) and post-LD.
[3] Primary WP: Completed study with no missed visits, had evaluable PD data through Day 11.



  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.
No text entered.

Reporting Groups
  Description
Clopidogrel 600 mg Clopidogrel 600 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 60 mg Prasugrel 60 mg taken orally, day one, single dose (Loading Dose [LD])
Prasugrel 30 mg Prasugrel 30 mg taken orally, day one, single dose (Loading Dose [LD])
Total Total of all reporting groups

Baseline Measures
    Clopidogrel 600 mg     Prasugrel 60 mg     Prasugrel 30 mg     Total  
Number of Participants  
[units: participants]
  10     10     9     29  
Age  
[units: years]
Mean ± Standard Deviation
  66.9  ± 8.54     65.6  ± 6.56     61.5  ± 10.01     64.8  ± 8.44  
Gender  
[units: participants]
       
Female     1     2     2     5  
Male     9     8     7     24  
Race/Ethnicity, Customized  
[units: participants]
       
White     10     10     9     29  
Region of Enrollment  
[units: participants]
       
Germany     10     10     9     29  



  Outcome Measures
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1.  Primary:   Percentage of Participants Returning to Baseline Platelet Function   [ Time Frame: Days 3, 5, 7, 9, and 11 ]

2.  Secondary:   The Day on Which 50%, 75% and 90% of Subjects Return to Baseline Platelet Function Following a Single LD of 30-mg or 60-mg Prasugrel or 600-mg Clopidogrel   [ Time Frame: Up through 11 days ]

3.  Secondary:   The Day When the Proportion of Participants Who Return to Baseline Platelet Function in the 30-mg and 60-mg Prasugrel Groups is Similar to the 600-mg Clopidogrel Group at Day 5 and Day 7   [ Time Frame: Up through 11 days ]

4.  Secondary:   Number of Days to the Return of Baseline Platelet Function Following One Loading Dose (LD)   [ Time Frame: Up through 11 days ]

5.  Secondary:   Effect of Initial Inhibition of Platelet Aggregation on the Day to Return to Baseline Platelet Function: VN-PRU   [ Time Frame: Up through 11 days ]

6.  Secondary:   Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by VN-PRU   [ Time Frame: Up through 11 days ]

7.  Secondary:   Platelet Function 24 Hours Post Loading Dose   [ Time Frame: 24 hours post-loading dose ]

8.  Secondary:   Percentage of Poor Pharmacodynamic Responders by Platelet Aggregation at 24 Hours Post-LD   [ Time Frame: 24 hours post-loading dose ]

9.  Secondary:   Extent of Initial Inhibition of Platelet Aggregation on the Return of Baseline Platelet Function: Light Transmission Aggregometry (LTA)   [ Time Frame: Up through 11 days ]

10.  Secondary:   Extent of Initial Inhibition of Platelet Aggregation to the Return of Baseline Platelet Function: Multiplate® ADP Test and ADP Test High Sensitivity (HS)   [ Time Frame: Up through 11 days ]

11.  Secondary:   Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hours Post-LD) by LTA (5 and 20 μM ADP)   [ Time Frame: Up through 11 days ]

12.  Secondary:   Mean Number of Days to the Return of Baseline Platelet Function in All Treatment Arms (Adjusted for Level of Inhibition 24 Hrs Post-LD) by Multiplate® ADP Test and ADP Test High Sensitivity (HS)   [ Time Frame: Up through 11 days ]

13.  Secondary:   Platelet Function by LTA at 5 and 20 μM ADP   [ Time Frame: 24 hours post-loading dose ]

14.  Secondary:   Platelet Function by Multiplate® ADP Test and ADP Test HS   [ Time Frame: 24 hours post-loading dose ]


  Serious Adverse Events


  Other Adverse Events


  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.


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
Trial was terminated early due to enrollment futility which resulted in limited data and the inability to analyze some outcome measures.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01107899     History of Changes
Other Study ID Numbers: 11983, H7T-MC-TACM
Study First Received: April 19, 2010
Results First Received: December 1, 2011
Last Updated: March 7, 2012
Health Authority: United States: Food and Drug Administration