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Third Optimizing Anti-Platelet Therapy in Diabetes MellitUS (OPTIMUS-3)

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00642174
First received: March 21, 2008
Last updated: February 19, 2010
Last verified: February 2010
History of Changes
Results First Received: January 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Diabetes Mellitus
Coronary Artery Disease
Interventions: Drug: prasugrel
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
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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
Prasugrel Then Clopidogrel Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
Clopidogrel Then Prasugrel Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.

Participant Flow for 2 periods

 Period 1:   Period 1 - Initial Drug
    Prasugrel Then Clopidogrel     Clopidogrel Then Prasugrel  
STARTED     18     17  
COMPLETED     18     16  
NOT COMPLETED     0     1  
Entry Criteria Not Met                 0                 1  

Period 2:   Period 2 - Crossover Drug
    Prasugrel Then Clopidogrel     Clopidogrel Then Prasugrel  
STARTED     18     16  
COMPLETED     18     16  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Reporting Groups
  Description
Prasugrel Then Clopidogrel Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose. Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose.
Clopidogrel Then Prasugrel Clopidogrel: Oral clopidogrel 600-mg loading dose, followed by 6 to 9 days of clopidogrel 150-mg/day tablet maintenance dose. Prasugrel: Oral prasugrel 60-mg loading dose, followed by 6 to 9 days of prasugrel 10-mg/day tablet maintenance dose.
Total Total of all reporting groups

Baseline Measures
    Prasugrel Then Clopidogrel     Clopidogrel Then Prasugrel     Total  
Number of Participants  
[units: participants]
 		  18     17     35  
Age  
[units: years]
Mean ± Standard Deviation 		  60.3  ± 9.43     62.4  ± 8.14     61.3  ± 8.76  
Gender  
[units: participants]
 		     
Female     4     7     11  
Male     14     10     24  
Race/Ethnicity, Customized  
[units: participants]
 		     
Caucasian     8     7     15  
African     3     4     7  
Hispanic     4     4     8  
Native American     0     1     1  
East Asian     1     0     1  
West Asian     2     1     3  
Region of Enrollment  
[units: participants]
 		     
United States     18     17     35  



  Outcome Measures
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1.  Primary:   Inhibition of Platelet Aggregation (IPA) 4 Hours After Loading Dose Assessed by Accumetrics VerifyNow™ P2Y12 Assay   [ Time Frame: 4 hours after loading dose ]
  Show Outcome Measure 1

2.  Secondary:   Inhibition of Platelet Aggregation at 1- and 24-Hours After Loading Dose (LD) and 24-Hours After Last Maintenance Dose (LMD) Assessed by Accumetrics VerifyNow™ P2Y12 Assay   [ Time Frame: 1 hour and 24 hours after the loading dose (LD) and 24 hours after the last maintenance dose (LMD) ]
  Show Outcome Measure 2

3.  Secondary:   Maximum Platelet Aggregation (MPA) as Assessed by Light Transmittance Aggregometry (LTA)   [ Time Frame: Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose ]
  Show Outcome Measure 3

4.  Secondary:   Platelet Reactivity Index (PRI)   [ Time Frame: Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose ]
  Show Outcome Measure 4

5.  Secondary:   Inhibition of Platelet Function as Measured by Thromboelastography (TEG)-Platelet Mapping Maximum Amplitude - Adenosine Diphosphate   [ Time Frame: Baseline, 1 Hour, 4 Hours, and 24 Hours after loading dose, and 24 Hours after last maintenance dose ]
  Show Outcome Measure 5


  Serious Adverse Events
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  Other Adverse Events
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  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
No text entered.  


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: Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier: NCT00642174     History of Changes
Other Study ID Numbers: 11241, H7T-MC-TACA
Study First Received: March 21, 2008
Results First Received: January 18, 2010
Last Updated: February 19, 2010
Health Authority: United States: Food and Drug Administration