A Comparison of Prasugrel at PCI or Time of Diagnosis of Non-ST Elevation Myocardial Infarction (ACCOAST)

This study has been completed.
Sponsor:
Collaborator:
Daiichi Sankyo Co., Ltd.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01015287
First received: November 17, 2009
Last updated: January 17, 2014
Last verified: January 2014
Results First Received: January 17, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Acute Coronary Syndromes
Interventions: Drug: Placebo
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
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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
Non Pre-treatment A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
Pre-treatment A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.

Participant Flow:   Overall Study
    Non Pre-treatment     Pre-treatment  
STARTED     1996     2037  
Received at Least 1 Dose of Study Drug     1996     2037  
COMPLETED     1924     1958  
NOT COMPLETED     72     79  
Death                 21                 16  
Adverse Event                 1                 0  
Sponsor Decision                 3                 7  
Physician Decision                 19                 21  
Withdrawal by Subject                 14                 19  
Entry Criteria not Met                 11                 14  
Lost to Follow-up                 2                 1  
Protocol Violation                 1                 1  



  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 randomized participants who received at least 1 dose of study drug.

Reporting Groups
  Description
Non Pre-treatment A placebo oral loading dose (LD) was given at the time of diagnosis and a 60 milligrams (mg) oral LD of prasugrel was given at the time of percutaneous coronary intervention (PCI) followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
Pre-treatment A 30 mg oral LD of prasugrel was given at diagnosis and a 30 mg oral dose of prasugrel was given at the time of PCI followed by 5 mg or 10 mg oral daily maintenance dose of prasugrel for 30 days.
Total Total of all reporting groups

Baseline Measures
    Non Pre-treatment     Pre-treatment     Total  
Number of Participants  
[units: participants]
  1996     2037     4033  
Age  
[units: years]
Mean ± Standard Deviation
  63.59  ± 11.239     63.80  ± 11.270     63.69  ± 11.254  
Gender  
[units: participants]
     
Female     558     552     1110  
Male     1438     1485     2923  



  Outcome Measures
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1.  Primary:   The Percentage of Participants With Occurrence of Cardiovascular (CV) Death, Myocardial Infarction (MI), Stroke, Urgent Revascularization (UR), or Glycoprotein (GP) IIb/IIIa Inhibitor Bailout   [ Time Frame: First loading dose (LD) through 7 days after first LD ]

2.  Secondary:   Percentage of Participants With All-Cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding   [ Time Frame: First loading dose (LD) through 7 days after first LD ]

3.  Secondary:   Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Stroke Through 30 Days From First Loading Dose (LD)   [ Time Frame: First LD through 30 days after first LD ]

4.  Secondary:   Percentage of Participants With Incidence of Cardiovascular (CV) Death or Myocardial Infarction (MI) Through 30 Days From First Loading Dose (LD)   [ Time Frame: First LD through 30 days after first LD ]

5.  Secondary:   Percentage of Participants With Incidence of Cardiovascular (CV) Death, Myocardial Infarction (MI), or Urgent Revascularization (UR) Through 30 Days From First Loading Dose (LD)   [ Time Frame: First LD through 30 days after first LD ]

6.  Secondary:   Percentage of Participants With Incidence of Cardiovascular (CV) Death Through 30 Days From First Loading Dose (LD)   [ Time Frame: First LD through 30 days after first LD ]

7.  Secondary:   Percentage of Participants With Incidence of Definite or Probable Stent Thrombosis (ST) According to the Academic Research Consortium (ARC) Criteria Through 30 Days From First Loading Dose (LD)   [ Time Frame: First LD through 30 days after first LD ]

8.  Secondary:   Percentage of Participants With All-cause Death, Myocardial Infarction (MI), Stroke, or All Coronary Artery Bypass Graft (CABG) and Non-CABG Thrombolysis in Myocardial Infarction (TIMI) Major Bleeding Through 30 Days From First Loading Dose (LD)   [ Time Frame: First LD through 30 days after first LD ]

9.  Secondary:   Change in Standardized Troponin From Baseline to Percutaneous Coronary Intervention (PCI)   [ Time Frame: Baseline, before PCI (not greater than 48 hours after randomization) ]

10.  Secondary:   Percentage of Participants With Incidence of All Coronary Artery Bypass Graft (CABG) or Non-CABG Thrombolysis In Myocardial Infarction (TIMI) Major Bleeding   [ Time Frame: First loading dose (LD) through 7 days after first LD ]

11.  Other Pre-specified:   Summary of All-Cause Death   [ Time Frame: Randomization through 30 days ]


  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


No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01015287     History of Changes
Other Study ID Numbers: 12918, H7T-MC-TADF
Study First Received: November 17, 2009
Results First Received: January 17, 2014
Last Updated: January 17, 2014
Health Authority: European Union: European Medicines Agency