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Comparison of Prasugrel and Clopidogrel in Very Elderly and Non-Elderly Patients With Stable Coronary Artery Disease (GENERATIONS)

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01107912
First received: April 19, 2010
Last updated: September 27, 2012
Last verified: September 2012
History of Changes
Results First Received: September 27, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Crossover Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: 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
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Reporting Groups
  Description
5 mg Prasugrel (Elderly) Elderly participants (≥75 Years of Age) received 5 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 10 mg prasugrel or 75 mg clopidogrel dose in Period 2.
10 mg Prasugrel (Elderly) Elderly participants ( ≥75 year of age) on 5 mg prasugrel in Period 1 who received 10 mg prasugrel during Period 2 or 3.
75 mg Clopidogrel (Elderly) Elderly participants (≥75 year of age) on 5 mg prasugrel in Period 1 who received 75 mg clopidogrel during Period 2 or 3.
5 mg Prasugrel (Non-Elderly) Non-elderly participants (≥45 to <65 years of age) on 10 mg prasugrel in Period 1 who received 5 mg prasugrel during Period 2 or 3.
10 mg Prasugrel (Non-Elderly) Non-elderly participants (≥45 to <65 years of age) received 10 mg prasugrel for 12 days during Period 1 without intervening or terminal washout periods. They were then switched to either the 5 mg prasugrel or 75 mg clopidogrel dose in Period 2.
75 mg Clopidogrel (Non-Elderly) Non-elderly participants ( ≥45 to <65 years of age) on 10 mg prasugrel during Period 1 who received 75 mg clopidogrel during Period 2 or 3.

Participant Flow for 3 periods

 Period 1:   Period 1
    5 mg Prasugrel (Elderly)     10 mg Prasugrel (Elderly)     75 mg Clopidogrel (Elderly)     5 mg Prasugrel (Non-Elderly)     10 mg Prasugrel (Non-Elderly)     75 mg Clopidogrel (Non-Elderly)  
STARTED     73     0     0     0     82     0  
Received at Least 1 Dose of Study Drug     73     0     0     0     82     0  
COMPLETED     72     0     0     0     79     0  
NOT COMPLETED     1     0     0     0     3     0  
Adverse Event                 0                 0                 0                 0                 2                 0  
Physician Decision                 0                 0                 0                 0                 1                 0  
Withdrawal by Subject                 1                 0                 0                 0                 0                 0  

Period 2:   Period 2
    5 mg Prasugrel (Elderly)     10 mg Prasugrel (Elderly)     75 mg Clopidogrel (Elderly)     5 mg Prasugrel (Non-Elderly)     10 mg Prasugrel (Non-Elderly)     75 mg Clopidogrel (Non-Elderly)  
STARTED     0 [1]   36     36     41     0 [2]   38  
COMPLETED     0     36     35     41     0     38  
NOT COMPLETED     0     0     1     0     0     0  
Physician Decision                 0                 0                 1                 0                 0                 0  
[1] Participants switched to either 10 mg prasugrel or 75 mg clopidogrel in Period 2.
[2] Participants switched to either 5 mg prasugrel or 75 mg clopidogrel in Period 2.

Period 3:   Period 3
    5 mg Prasugrel (Elderly)     10 mg Prasugrel (Elderly)     75 mg Clopidogrel (Elderly)     5 mg Prasugrel (Non-Elderly)     10 mg Prasugrel (Non-Elderly)     75 mg Clopidogrel (Non-Elderly)  
STARTED     0     35 [1]   36 [2]   38 [3]   0     41 [4]
COMPLETED     0     34     35     37     0     41  
NOT COMPLETED     0     1     1     1     0     0  
Adverse Event                 0                 1                 1                 0                 0                 0  
Withdrawal by Subject                 0                 0                 0                 1                 0                 0  
[1] Participants who received 75 mg clopidogrel in Period 2 received 10 mg prasugrel in Period 3
[2] Participants who received 10 mg prasugrel in Period 2 received 75 mg clopidogrel in Period 3
[3] Participants who received 75 mg clopidogrel in Period 2 received 5 mg prasugrel in Period 3
[4] Participants who received 5 mg prasugrel in Period 2 received 75 mg clopidogrel in Period 3



  Baseline Characteristics
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Reporting Groups
  Description
Very Elderly, Drug Sequence ABC Participants (≥75 years of age) in this arm received study drug sequence ABC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
Very Elderly; Drug Sequence ACB Participants (≥75 years of age) in this arm received study drug sequence ACB. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
Non-Elderly; Drug Sequence BAC Participants (≥45 to <65 years of age) in this arm received study drug sequence BAC. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
Non-Elderly; Drug Sequence BCA Participants (≥45 to <65 years of age) in this arm received study drug sequence BCA. A = Prasugrel 5mg, B = Prasugrel 10mg, C = Clopidogrel 75mg.
Total Total of all reporting groups

Baseline Measures
    Very Elderly, Drug Sequence ABC     Very Elderly; Drug Sequence ACB     Non-Elderly; Drug Sequence BAC     Non-Elderly; Drug Sequence BCA     Total  
Number of Participants  
[units: participants]
 		  36     37     42     40     155  
Age  
[units: years]
Mean ± Standard Deviation 		  79.02  ± 2.87     78.74  ± 3.12     57.11  ± 4.75     55.46  ± 5.53     66.94  ± 12.08  
Gender  
[units: participants]
 		         
Female     8     11     7     10     36  
Male     28     26     35     30     119  
Ethnicity (NIH/OMB)  
[units: participants]
 		         
Hispanic or Latino     0     0     1     0     1  
Not Hispanic or Latino     8     7     9     14     38  
Unknown or Not Reported     28     30     32     26     116  
Race (NIH/OMB)  
[units: participants]
 		         
American Indian or Alaska Native     0     0     0     0     0  
Asian     0     0     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0     0     0  
Black or African American     1     3     1     7     12  
White     35     34     40     32     141  
More than one race     0     0     1     1     2  
Unknown or Not Reported     0     0     0     0     0  
Region of Enrollment  
[units: participants]
 		         
United States     8     7     10     14     39  
Ireland     3     3     7     6     19  
Netherlands     3     4     2     1     10  
Sweden     22     23     23     19     87  
Weight  
[units: kilograms (kg)]
Mean ± Standard Deviation 		  88.49  ± 10.92     82.30  ± 10.74     92.85  ± 20.01     93.36  ± 17.32     89.45  ± 16.01  
Tobacco Use Status at Baseline  
[units: participants]
 		         
Yes     4     1     13     11     29  
No     32     36     29     29     126  



  Outcome Measures
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1.  Primary:   Change in Maximum Platelet Aggregation (MPA) to 20 Micromoles (μM) Adenosine Diphosphate (ADP) as Measured by Light Transmission Aggregometry (LTA) From Baseline to 12 Days of Therapy in the First Treatment Period   [ Time Frame: Baseline, 12 days ]
  Show Outcome Measure 1

2.  Secondary:   Change in Vasodilator-associated Stimulated Phosphoprotein (VASP) From Baseline to 12 Days of Therapy   [ Time Frame: Baseline, Day 12 ]
  Show Outcome Measure 2

3.  Secondary:   Change in VerifyNow P2Y12 Reaction Units (PRU) From Baseline to 12 Days of Therapy   [ Time Frame: Baseline, Day 12 ]
  Show Outcome Measure 3

4.  Secondary:   Active Metabolite Blood Levels to Drug Exposure as Measured by Pharmacokinetics (PK) Through 4 Hours After Dosing   [ Time Frame: Baseline up to 4 hours post-dose ]
  Show Outcome Measure 4

5.  Secondary:   Change From Baseline in Maximum Platelet Aggregation (MPA) as Measured by Light Transmission Aggregometry (LTA) From Baseline at Day 12 of Therapy   [ Time Frame: Baseline, Day 12 ]
  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
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 800-545-5979


No publications provided


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01107912     History of Changes
Other Study ID Numbers: 12835, H7T-MC-TACY
Study First Received: April 19, 2010
Results First Received: September 27, 2012
Last Updated: September 27, 2012
Health Authority: United States: Food and Drug Administration
Sweden: Medical Products Agency
Ireland: Irish Medicines Board
Netherlands: Medicines Evaluation Board (MEB)