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Sponsors and Collaborators: |
University Medical Centre Groningen The Interuniversity Cardiology Institute of the Netherlands Janssen-Cilag Ltd. |
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Information provided by: | University Medical Centre Groningen |
ClinicalTrials.gov Identifier: | NCT00449488 |
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.
Condition | Intervention | Phase |
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Myocardial Infarction |
Drug: epoetin alfa |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 466 |
Study Start Date: | January 2007 |
Estimated Study Completion Date: | January 2009 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Successful primary PCI (TIMI 2/3) for a first acute myocardial infarction, diagnosed by:
Exclusion Criteria:
Contact: Adriaan A Voors, MD, PhD | 0031503613874 | A.A.Voors@thorax.umcg.nl |
Contact: Anne MS Belonje, MD | 0031503610321 | A.M.S.Belonje@thorax.umcg.nl |
Netherlands | |
University Medical Center Groningen | Recruiting |
Groningen, Netherlands, 9700RB |
Principal Investigator: | A A Voors, MD,PhD | University Medical Centre Groningen |
Principal Investigator: | F Zijlstra, MD,PhD,FACC | University Medical Centre Groningen |
Principal Investigator: | DJ van Veldhuisen, MD,PhD,FACC | University Medical Centre Groningen |
Study ID Numbers: | B213, ISRCTN46528154 |
Study First Received: | March 18, 2007 |
Last Updated: | March 21, 2007 |
ClinicalTrials.gov Identifier: | NCT00449488 |
Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
erythropoietin myocardial infarction PCI left ventricular function |
Epoetin Alfa Necrosis Heart Diseases Myocardial Ischemia |
Vascular Diseases Ischemia Infarction Myocardial Infarction |
Pathologic Processes Hematinics Therapeutic Uses |
Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |