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Treatment With Adenosine Diphosphate (ADP) Receptor Inhibitors: Longitudinal Assessment of Treatment Patterns and Events After Acute Coronary Syndrome (TRANSLATE-ACS)

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01088503
First received: March 15, 2010
Last updated: December 22, 2015
Last verified: December 2015
Results First Received: January 29, 2015  
Study Type: Observational
Study Design: Observational Model: Cohort;   Time Perspective: Prospective
Condition: Acute Coronary Syndrome
Intervention: Drug: ADP receptor inhibitors

  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
Centralized follow-up visits were conducted for all participants. Participants who completed 15-month active follow-up were considered to have completed the study.

Reporting Groups
  Description
Prasugrel Participants who were admitted for non ST elevation myocardial infarction (NSTEMI) or ST elevation myocardial infarction (STEMI) underwent percutaneous coronary intervention (PCI) and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Clopidogrel Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Ticlopidine/Ticagrelor Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.

Participant Flow:   Overall Study
    Prasugrel     Clopidogrel     Ticlopidine/Ticagrelor  
STARTED     3123     8846     258  
COMPLETED     2941     8161     241  
NOT COMPLETED     182     685     17  
Withdrawal by Subject                 118                 327                 10  
Death                 64                 358                 7  



  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.
All enrolled participants.

Reporting Groups
  Description
Prasugrel Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with prasugrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Clopidogrel Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with clopidogrel during the index hospitalization. Dosage regimen was determined by the treating physician.
Ticlopidine/Ticagrelor Participants who were admitted for NSTEMI or STEMI underwent PCI and were treated with ticlopidine or ticagrelor during the index hospitalization. Dosage regimen was determined by the treating physician.
Total Total of all reporting groups

Baseline Measures
    Prasugrel     Clopidogrel     Ticlopidine/Ticagrelor     Total  
Number of Participants  
[units: participants]
  3123     8846     258     12227  
Age, Customized  
[units: participants]
       
≥75 years     88     1341     33     1462  
<75 years     3035     7505     225     10765  
Gender  
[units: participants]
       
Female     672     2671     91     3434  
Male     2451     6175     167     8793  
Ethnicity (NIH/OMB)  
[units: participants]
       
Hispanic or Latino     129     271     13     413  
Not Hispanic or Latino     2986     8525     244     11755  
Unknown or Not Reported     8     50     1     59  
Race (NIH/OMB)  
[units: participants]
       
American Indian or Alaska Native     35     39     0     74  
Asian     55     94     1     150  
Native Hawaiian or Other Pacific Islander     12     13     0     25  
Black or African American     237     820     30     1087  
White     2750     7778     225     10753  
More than one race     0     0     0     0  
Unknown or Not Reported     34     102     2     138  
Region of Enrollment  
[units: participants]
       
United States     3123     8846     258     12227  



  Outcome Measures
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1.  Primary:   Percentage of Participants With Major Adverse Cardiovascular Events (MACE)   [ Time Frame: Baseline through 12 months ]

2.  Primary:   Factors Associated With Initial Adenosine Diphosphate (ADP) Receptor Inhibitor Selection at Enrollment   [ Time Frame: Day 0 (study enrollment) ]

3.  Primary:   Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Pre-Procedure Hemoglobin   [ Time Frame: Day 0 (study enrollment) ]

4.  Primary:   Factors Associated With Initial ADP Receptor Inhibitor Selection at Enrollment: Duke Coronary Artery Disease (CAD) Index   [ Time Frame: Day 0 (study enrollment) ]

5.  Secondary:   Percentage of Participants With Cumulative Severe or Moderate Bleeding Events   [ Time Frame: Baseline, 1, 6, 12 and 15 months ]

6.  Secondary:   Percentage of Participants With MACE and Who Had No Prior History of Transient Ischemic Attack (TIA)/Stroke, Weigh ≥60 Kilograms (kg), and Are Age <75 Years   [ Time Frame: Baseline through 12 months ]

7.  Secondary:   Percentage of Participants With MACE Over 1, 6 and 15 Months   [ Time Frame: Baseline through 1, 6 and 15 months ]

8.  Secondary:   Percentage of Participants With Definite or Probable Stent Thrombosis (ST) Events   [ Time Frame: Baseline through 15 months ]

9.  Secondary:   Resource Use Patterns, Cumulative Total Medical Costs, and Cost Effectiveness   [ Time Frame: 15 months ]


  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
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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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01088503     History of Changes
Other Study ID Numbers: 12549
H7T-US-B007 ( Other Identifier: Eli Lilly and Company )
Study First Received: March 15, 2010
Results First Received: January 29, 2015
Last Updated: December 22, 2015
Health Authority: United States: Institutional Review Board