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

March 16, 2010
February 28, 2012
April 2010
September 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01093820 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction
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

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®.

Interventional
Phase 2
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Myocardial Infarction
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
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
8
October 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01093820
2010 DR 2029
Yes
University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
Not Provided
Principal Investigator: Matthias Pfisterer, Prof. MD University Hospital, Basel, Switzerland
University Hospital, Basel, Switzerland
February 2012

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