ClinicalTrials.Veeva

Menu

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

University Hospital Basel logo

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)

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

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems