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

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ClinicalTrials.gov Identifier: NCT01093820
Recruitment Status : Completed
First Posted : March 26, 2010
Last Update Posted : February 29, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

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


Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Drug: methoxy-polyethyleneglycol epoetin beta Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)
Study Start Date : April 2010
Primary Completion Date : September 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months [ Time Frame: three months ]
    measurement of Hb at baseline and month 1, 2 and 3


Secondary Outcome Measures :
  1. Maximal change in Hb within 3 months relative to baseline [ Time Frame: three months ]
    measurement of Hb at baseline and month 1, 2 and 3

  2. Relative change in Hb from baseline to 1 months [ Time Frame: first month ]
    measurement of Hb at baseline and month 1

  3. Maximal change in Hematocrit (Hk) within 3 months relative to baseline [ Time Frame: three months ]
    measurement of Hk at baseline and month 1, 2 and 3

  4. change in platelet count within 3 months relative to baseline [ Time Frame: three months ]
    measurement of platelet count at baseline and month 1, 2 and 3

  5. 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 ]
    follow-up at month 1, 2 and 3

  6. Relative change in Hb from 1 to 2 months [ Time Frame: second month ]
    measurement of Hb at month 1 and 2

  7. Relative change in Hb from 2 to 3 months [ Time Frame: third month ]
    measurement of Hb at month 2 and 3



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT01093820     History of Changes
Other Study ID Numbers: 2010 DR 2029
First Posted: March 26, 2010    Key Record Dates
Last Update Posted: February 29, 2012
Last Verified: February 2012

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