Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

This study has been completed.
Sponsor:
Collaborator:
American Heart Association
Information provided by:
Yale University
ClinicalTrials.gov Identifier:
NCT00368238
First received: August 23, 2006
Last updated: NA
Last verified: August 2006
History: No changes posted

August 23, 2006
August 23, 2006
October 2005
Not Provided
  • Bleeding time
  • Platelet function assay closure time
Same as current
No Changes Posted
  • Complete Blood Count
  • PT
  • PTT
  • P-selectin
  • von Willebrand factor
Same as current
Not Provided
Not Provided
 
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects
Effects of Recombinant Human Erythropoietin on Platelet Function in Healthy Subjects

The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Erythropoietin is made by the kidneys to stimulate red blood cell production to prevent anemia. Platelets are small cells in the blood that help clot blood in case of injury. Platelets also sometimes form blood clots in blood vessels that may cause heart attacks. This study is trying to determine whether erythropoietin increases the clotting action of platelets. Information on erythropoietin in healthy subjects may eventually help in the treatment of patients with heart attacks.

Anti-apoptotic effects of erythropoietin in experimental myocardial infarction and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of rHuEpo in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of 3 doses of rHuEpo (100U/kg, 200U/kg and 400U/kg daily for 3 days) on platelet function and other safety measures in healthy subjects.

Specific Aim: To determine the effects of three ascending doses of rHuEpo vs. placebo on in vivo and in vitro platelet function in healthy subjects treated with aspirin and clopidogrel.

Hypotheses to be tested: 1) 1) Short-term administration of rHuEpo does not alter bleeding time responses to aspirin and clopidogrel when compared with placebo. 2) Short-term administration does not alter in vitro platelet aggregation responses to aspirin and clopidogrel when compared with placebo.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Healthy Subjects
  • Drug: Recombinant human erythropoietin alfa (drug)
  • Drug: Aspirin (drug)
  • Drug: Clopidogrel (drug)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
96
July 2006
Not Provided

Inclusion Criteria:

  • Age 21-40 years
  • Able and willing to provide written informed consent
  • Bleeding time <10 minutes

Exclusion Criteria:

  • Any chronic medical disease
  • Chronic or frequent over-the-counter or prescription medication use
  • Hemoglobin >15 gm/dl for both genders or <13 gm/dl (men) or <12 gm/dl (women)
  • Platelet count >400,000/µl or <150,000/µl
  • Blood pressure > 140/90 mmHg
Both
21 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00368238
0506000139, AHA 0555844T
Not Provided
Not Provided
Yale University
American Heart Association
Principal Investigator: Stuart D Katz, MD Yale University
Yale University
August 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP