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
  Purpose

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


Condition Intervention Phase
Acute Myocardial Infarction
Drug: methoxy-polyethyleneglycol epoetin beta
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)

Resource links provided by NLM:


Further study details as provided by University Hospital, Basel, Switzerland:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 8
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Mircera

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®.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093820

Locations
Switzerland
University Hospital Basel
Basel, Switzerland, 4031
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
Principal Investigator: Matthias Pfisterer, Prof. MD University Hospital, Basel, Switzerland
  More Information

No publications provided

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01093820     History of Changes
Other Study ID Numbers: 2010 DR 2029
Study First Received: March 16, 2010
Last Updated: February 28, 2012
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital, Basel, Switzerland:
acute myocardial infarction
continuous erythropoetin receptor activator
Mircera
hemoglobin kinetics

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014