EARLY ACS: Early Glycoprotein IIb/IIIa Inhibition in Patients With Non-ST-segment Elevation Acute Coronary Syndrome (Study P03684AM2)(COMPLETED)

This study has been completed.
Sponsor:
Collaborator:
Duke Clinical Research Institute
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00089895
First received: August 17, 2004
Last updated: April 25, 2014
Last verified: April 2014
Results First Received: November 13, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Myocardial Ischemia
Acute Coronary Syndrome
Interventions: Drug: Eptifibatide (Integrilin)
Drug: Placebo

  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
Patients in both treatment groups who were undergoing PCI could receive unblinded eptifibatide provisionally immediately before or during percutaneous coronary intervention (PCI) at the discretion of the investigator.

Reporting Groups
  Description
Eptifibatide Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
Placebo Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.

Participant Flow:   Overall Study
    Eptifibatide     Placebo  
STARTED     4722 [1]   4684 [1]
COMPLETED     4687 [2]   4642 [2]
NOT COMPLETED     35     42  
Consent Withdrawn                 11                 14  
Technical reason                 7                 2  
Surgery                 0                 1  
Bleeding                 0                 2  
Physician Decision                 3                 7  
Exclusion criteria met                 6                 6  
Not otherwise specified                 4                 8  
Missing                 4                 2  
[1] Number of Subjects Randomized with Intent to Treat
[2] Number of Subjects treated



  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
Eptifibatide Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
Placebo Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
Total Total of all reporting groups

Baseline Measures
    Eptifibatide     Placebo     Total  
Number of Participants  
[units: participants]
  4722     4684     9406  
Age  
[units: years]
Mean ± Standard Deviation
  66.4  ± 10.6     66.7  ± 10.7     66.6  ± 10.7  
Gender  
[units: participants]
     
Female     1513     1462     2975  
Male     3209     3222     6431  



  Outcome Measures
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1.  Primary:   Incidence of the Composite of Death, Myocardial Infarction (MI), Recurrent Ischemia Requiring Urgent Revascularization (RI-UR), and Thrombotic Bail-out.   [ Time Frame: 96 hours after randomization ]

2.  Secondary:   Incidence of the Composite of Death/MI.   [ Time Frame: 30 days after randomization ]


  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 more than 60 days but less than or equal to 180 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: Vice President, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp.
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided by Merck Sharp & Dohme Corp.

Publications automatically indexed to this study:


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00089895     History of Changes
Other Study ID Numbers: P03684
Study First Received: August 17, 2004
Results First Received: November 13, 2009
Last Updated: April 25, 2014
Health Authority: United States: Food and Drug Administration