Trial | NCT00449488  Report issue

Title

Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction
A Prospective, Randomised, Clinical Study to Examine the Effects of a Single Bolus Erythropoietin on Left Ventricular Function in Patients With an Acute Myocardial Infarction

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    epoetin ...

  • Study Participants

    529
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.
Study Started
Jan 31
2007
Primary Completion
Oct 31
2009
Study Completion
Oct 31
2009
Last Update
Dec 15
2009
Estimate

Drug epoetin alfa

epoetin alfa 60.000 IU one i.v. bolus

  • Other names: Eprex

Control No Intervention

Epoetin alfa Active Comparator

i.v bolus 60.000 IU epoetin alfa

Criteria 

Inclusion Criteria:

Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:

chest pain suggestive for acute myocardial infarction
symptom onset < 12 hour before hospital admission, or < 24 hour in case ongoing ischemia
ECG with ST-T segment elevation > 1 mV in 2 or more leads
TIMI flow 0/1 before primary PCI on diagnostic coronary angiography;

Exclusion Criteria:

Hemoglobin levels > 10.6 mmol/L;
Anticipated additional revascularisation within 4 months;
Cardiogenic shock;
Presence of other serious medical conditions
Pregnancy/breast feeding
Malignant hypertension
End stage renal failure (creatinin > 220 micromol/l)
Previous treatment with rh-EPO
Blood transfusion <12 weeks prior to randomisation
Polycythemia vera
Previous acute myocardial infarction
Concomitant inflammatory or malignant disease
Recent trauma or major surgery
Unwilling to sign informed consent
Atrial fibrillation
No Results Posted