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

University Hospital Basel

Status and phase: Completed; Phase 2

Conditions: Acute Myocardial Infarction

Treatments: Drug: methoxy-polyethyleneglycol epoetin beta

Study type: Interventional

Funder types: Other

Identifiers

NCT01093820

2010 DR 2029

Details and patient eligibility

About

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

Full 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®.

Enrollment: 8 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Epopoetinum beta

Experimental group

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

Treatment:

Drug: methoxy-polyethyleneglycol epoetin beta