Healthy Subjects Clinical Trial
Official title:
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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