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

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Phase 2
Locations
Switzerland
Study Type
Interventional
Intervention
methoxy-polyethyleneglycol epoetin beta
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring acute myocardial infarction, continuous erythropoetin receptor activator, Mircera, hemoglobin kinetics

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital Basel

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Epopoetinum beta

Arm Description

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

Outcomes

Primary Outcome Measures

Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months
measurement of Hb at baseline and month 1, 2 and 3

Secondary Outcome Measures

Maximal change in Hb within 3 months relative to baseline
measurement of Hb at baseline and month 1, 2 and 3
Relative change in Hb from baseline to 1 months
measurement of Hb at baseline and month 1
Maximal change in Hematocrit (Hk) within 3 months relative to baseline
measurement of Hk at baseline and month 1, 2 and 3
change in platelet count within 3 months relative to baseline
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
follow-up at month 1, 2 and 3
Relative change in Hb from 1 to 2 months
measurement of Hb at month 1 and 2
Relative change in Hb from 2 to 3 months
measurement of Hb at month 2 and 3

Full Information

First Posted
March 16, 2010
Last Updated
February 28, 2012
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01093820
Brief Title
Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction
Acronym
BEATSTEMIPi
Official Title
Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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®.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
acute myocardial infarction, continuous erythropoetin receptor activator, Mircera, hemoglobin kinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epopoetinum beta
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
methoxy-polyethyleneglycol epoetin beta
Other Intervention Name(s)
Mircera
Intervention Description
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
Primary Outcome Measure Information:
Title
Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months
Description
measurement of Hb at baseline and month 1, 2 and 3
Time Frame
three months
Secondary Outcome Measure Information:
Title
Maximal change in Hb within 3 months relative to baseline
Description
measurement of Hb at baseline and month 1, 2 and 3
Time Frame
three months
Title
Relative change in Hb from baseline to 1 months
Description
measurement of Hb at baseline and month 1
Time Frame
first month
Title
Maximal change in Hematocrit (Hk) within 3 months relative to baseline
Description
measurement of Hk at baseline and month 1, 2 and 3
Time Frame
three months
Title
change in platelet count within 3 months relative to baseline
Description
measurement of platelet count at baseline and month 1, 2 and 3
Time Frame
three months
Title
Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures
Description
follow-up at month 1, 2 and 3
Time Frame
three months
Title
Relative change in Hb from 1 to 2 months
Description
measurement of Hb at month 1 and 2
Time Frame
second month
Title
Relative change in Hb from 2 to 3 months
Description
measurement of Hb at month 2 and 3
Time Frame
third month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthias Pfisterer, Prof. MD
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

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

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