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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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Heart Diseases
Ischemia
Myocardial Ischemia
Necrosis
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014