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

February 28, 2012 updated by: University Hospital, Basel, Switzerland

Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This pilot trial will include 8 patients. The inclusion of 8 patients will allow to perform representative statistics of expected Hb kinetics in response to Mircera®.

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients (age 18 - 80 years) with acute STEMI undergoing PCI

Main Exclusion Criteria:

  • Hemoglobin levels >15g/dL
  • history of a myeloproliferative syndrome
  • thrombolysis for index infarction
  • anticipated additional revascularization within 3 months
  • cardiogenic shock

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
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
Other Names:
  • Mircera

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months
Time Frame: three months
measurement of Hb at baseline and month 1, 2 and 3
three months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximal change in Hb within 3 months relative to baseline
Time Frame: three months
measurement of Hb at baseline and month 1, 2 and 3
three months
Relative change in Hb from baseline to 1 months
Time Frame: first month
measurement of Hb at baseline and month 1
first month
Maximal change in Hematocrit (Hk) within 3 months relative to baseline
Time Frame: three months
measurement of Hk at baseline and month 1, 2 and 3
three months
change in platelet count within 3 months relative to baseline
Time Frame: three months
measurement of platelet count at baseline and month 1, 2 and 3
three months
Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures
Time Frame: three months
follow-up at month 1, 2 and 3
three months
Relative change in Hb from 1 to 2 months
Time Frame: second month
measurement of Hb at month 1 and 2
second month
Relative change in Hb from 2 to 3 months
Time Frame: third month
measurement of Hb at month 2 and 3
third month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Principal Investigator: Matthias Pfisterer, Prof. MD, University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

March 16, 2010

First Submitted That Met QC Criteria

March 25, 2010

First Posted (Estimate)

March 26, 2010

Study Record Updates

Last Update Posted (Estimate)

February 29, 2012

Last Update Submitted That Met QC Criteria

February 28, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010 DR 2029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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