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Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction

NCT01093820 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2012-02-29

No results posted yet for this study

Summary

Hypothesis:

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

Conditions

  • Acute Myocardial Infarction

Interventions

DRUG

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

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Principal Investigators

  • Matthias Pfisterer, Prof. MD · University Hospital, Basel, Switzerland

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2010-09-30
Completion
2010-10-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01093820 on ClinicalTrials.gov