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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

University Hospital, Basel, Switzerland

ClinicalTrials.gov Identifier:

NCT01093820

First received: March 16, 2010

Last updated: February 28, 2012

Last verified: February 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 16, 2010

Last Updated Date

February 28, 2012

Start Date ^ICMJE

April 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months [ Time Frame: three months ] [ Designated as safety issue: Yes ]

measurement of Hb at baseline and month 1, 2 and 3

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01093820 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Maximal change in Hb within 3 months relative to baseline [ Time Frame: three months ] [ Designated as safety issue: Yes ]
measurement of Hb at baseline and month 1, 2 and 3
Relative change in Hb from baseline to 1 months [ Time Frame: first month ] [ Designated as safety issue: Yes ]
measurement of Hb at baseline and month 1
Maximal change in Hematocrit (Hk) within 3 months relative to baseline [ Time Frame: three months ] [ Designated as safety issue: Yes ]
measurement of Hk at baseline and month 1, 2 and 3
change in platelet count within 3 months relative to baseline [ Time Frame: three months ] [ Designated as safety issue: Yes ]
measurement of platelet count at baseline and month 1, 2 and 3
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 ] [ Designated as safety issue: Yes ]
follow-up at month 1, 2 and 3
Relative change in Hb from 1 to 2 months [ Time Frame: second month ] [ Designated as safety issue: Yes ]
measurement of Hb at month 1 and 2
Relative change in Hb from 2 to 3 months [ Time Frame: third month ] [ Designated as safety issue: Yes ]
measurement of Hb at month 2 and 3

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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

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 ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Myocardial Infarction

Intervention ^ICMJE

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 Name: Mircera

Study Arm (s)

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

Intervention: Drug: methoxy-polyethyleneglycol epoetin beta

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

October 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Switzerland

Administrative Information

NCT Number ^ICMJE

NCT01093820

Other Study ID Numbers ^ICMJE

2010 DR 2029

Has Data Monitoring Committee

Yes

Responsible Party

University Hospital, Basel, Switzerland

Study Sponsor ^ICMJE

University Hospital, Basel, Switzerland

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Matthias Pfisterer, Prof. MD

University Hospital, Basel, Switzerland

Information Provided By

University Hospital, Basel, Switzerland

Verification Date

February 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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