A Phase 2 interventional study of epoetin alfa in Myocardial Infarction, sponsored by University Medical Center Groningen. Completed at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-12-15.
Sponsored by University Medical Center Groningen · Phase 2, Interventional, and Treatment
The primary objective of this study is to establish the effects of a single bolus of EPO, administered within three hours after a primary PCI for a first acute myocardial infarction, on left ventricular function.
Erythropoetin (EPO) is commonly known as an effective treatment for anemia. However, several important extra-hematopoeitic effects of EPO are suggested which might be beneficial in the setting of an acute myocardial infarction, such as a reduction of apoptosis and stimulation of neovascularisation. Recent animal studies provided very consistent evidence for a reduced infarct size and improved left ventricular function caused by EPO administration. However, clinical studies with EPO in non-anemic patients are scarce.
We performed a safety study in our department on the effects of a single bolus of EPO in patients with an acute myocardial infarction. Serum EPO levels increased a 200-fold and EPO administration was not associated with hypertension, nor with an increase in thrombocytes or thrombotic events.
In conclusion, experimental data clearly showed that a single bolus of EPO after the onset of an acute myocardial infarction reduced myocardial infarct size, and improved left ventricular function. In our safety study, EPO administration in patients with an acute myocardial infarction was safe and well tolerated.
This will be a PROBE (Prospective, Randomised, Open label study with Blinded Endpoint) designed study, in wich one group will receive one bolus of EPO 60.000 IU) intravenously within 3 hours after the primary PCI procedure and the other group will receive standard therapy. After 6 weeks left ventricular ejection fraction will be evaluated by planar radionuclide ventriculography.
2,779 studies on the registry are indexed under Myocardial Infarction; 417 are open to participants now.
This study's enrollment of 529 is above the median of 148 across 1,613 interventional studies indexed under Myocardial Infarction.
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Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:
Exclusion Criteria:
i.v bolus 60.000 IU epoetin alfa
Drug: epoetin alfa
epoetin alfa 60.000 IU one i.v. bolus
Also known as: Eprex
Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography
Time frame: 6 weeks
Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO
Time frame: Cardiovascular Events
This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Epoetin Alfa
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