Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction

Phase 2

Completed

• Conditions: Myocardial Infarction
• Interventions: Drug: epoetin alfa

• Registration Number: NCT00449488
• Lead Sponsor: University Medical Center Groningen

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2007-01
• Study First Submitted: 2007-03-18
• Study First Submitted QC: 2007-03-18
• Study First Posted: 2007-03-20
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-14
• Last Update Posted: 2009-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 529

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Epoetin alfa	epoetin alfa	i.v bolus 60.000 IU epoetin alfa

Primary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction 6 weeks after primary PCI, measured with planar radionuclide ventriculography	6 weeks

Secondary Outcome Measures

Name	Time	Method
Safety, myocardial infarct size, and cardiovascular events at 6 weeks after a single bolus of EPO	Cardiovascular Events

Trial Locations

Locations (1)

University Medical Center Groningen; 🇳🇱 Groningen, Netherlands