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Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT00367991
First received: August 23, 2006
Last updated: September 14, 2011
Last verified: September 2011
History of Changes
Results First Received: August 9, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Myocardial Infarction
Interventions: Drug: Recombinant human erythropoietin alfa (drug)
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
No text entered.

Reporting Groups
  Description
rHuEPO recombinant human erythropoietin 200 U/kg IV daily for 3 days
Placebo Normal saline volume to match active treatment IV daily for 3 days

Participant Flow:   Overall Study
    rHuEPO     Placebo  
STARTED     29     15  
COMPLETED     27     13  
NOT COMPLETED     2     2  
Withdrawal by Subject                 1                 1  
Adverse Event                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
rHuEPO recombinant human erythropoietin 200 U/kg IV daily for 3 days
Placebo Normal saline volume to match active treatment IV daily for 3 days
Total Total of all reporting groups

Baseline Measures
    rHuEPO     Placebo     Total  
Number of Participants  
[units: participants]
 		  29     15     44  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     22     13     35  
>=65 years     7     2     9  
Age  
[units: years]
Mean ± Standard Deviation 		  58  ± 12     53  ± 9     56  ± 11  
Gender  
[units: participants]
 		     
Female     8     5     13  
Male     21     10     31  
Region of Enrollment  
[units: participants]
 		     
United States     29     15     44  



  Outcome Measures

1.  Primary:   Bleeding Time   [ Time Frame: Day 3 and Day 10 ]
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2.  Primary:   Platelet Function Assay Closure Time   [ Time Frame: Day 3 and Day 10 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   Yes

3.  Secondary:   Left Ventricular Ejection Fraction   [ Time Frame: Day 1 and Day 10 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Serum Markers of Myocyte Damage and Apoptosis   [ Time Frame: Day 1 and Day 10 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

5.  Secondary:   Circulating Endothelial Progenitor Cells   [ Time Frame: Day 3 and Day 10 ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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