Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction
NCT ID: NCT01093820
Last Updated: 2012-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
8 participants
INTERVENTIONAL
2010-04-30
2010-10-31
Brief Summary
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Based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI) does not result in hemoglobin (Hb) levels \>15 g/dl in patients with ST-segment elevation myocardial infarction (STEMI)
Design:
Prospective, open label single center pilot study
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epopoetinum beta
Mircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI
methoxy-polyethyleneglycol epoetin beta
Mircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI
Interventions
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methoxy-polyethyleneglycol epoetin beta
Mircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* history of a myeloproliferative syndrome
* thrombolysis for index infarction
* anticipated additional revascularization within 3 months
* cardiogenic shock
18 Years
80 Years
ALL
No
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Responsible Party
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Principal Investigators
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Matthias Pfisterer, Prof. MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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University Hospital Basel
Basel, , Switzerland
Countries
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Other Identifiers
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2010 DR 2029
Identifier Type: -
Identifier Source: org_study_id