Status:
COMPLETED
Clinical Study to Examine the Effects of Erythropoietin on Left Ventricular Function After Acute Myocardial Infarction
Lead Sponsor:
University Medical Center Groningen
Collaborating Sponsors:
The Interuniversity Cardiology Institute of the Netherlands
Janssen-Cilag Ltd.
Conditions:
Myocardial Infarction
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ventricul...
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 a...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
529 Patients enrolled
Trial Details
Trial ID
NCT00449488
Start Date
January 1 2007
End Date
October 1 2009
Last Update
December 15 2009
Active Locations (1)
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1
University Medical Center Groningen
Groningen, Provincie Groningen, Netherlands, 9700RB