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

Phase 2

Completed

• Conditions: Acute Myocardial Infarction
• Interventions: Drug: methoxy-polyethyleneglycol epoetin beta

• Registration Number: NCT01093820
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2010-03-16
• Study First Submitted QC: 2010-03-25
• Study First Posted: 2010-03-26
• Study Start: 2010-04
• Primary Completion: 2010-09
• Study Completion: 2010-10
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-28
• Last Update Posted: 2012-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Epopoetinum beta	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

Primary Outcome Measures

Name	Time	Method
Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months	three months	measurement of Hb at baseline and month 1, 2 and 3

Secondary Outcome Measures

Name	Time	Method
Maximal change in Hb within 3 months relative to baseline	three months	measurement of Hb at baseline and month 1, 2 and 3
Relative change in Hb from baseline to 1 months	first month	measurement of Hb at baseline and month 1
Relative change in Hb from 1 to 2 months	second month	measurement of Hb at month 1 and 2
Maximal change in Hematocrit (Hk) within 3 months relative to baseline	three months	measurement of Hk at baseline and month 1, 2 and 3
change in platelet count within 3 months relative to baseline	three months	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	three months	follow-up at month 1, 2 and 3
Relative change in Hb from 2 to 3 months	third month	measurement of Hb at month 2 and 3

Trial Locations

Locations (1)

University Hospital Basel; 🇨🇭 Basel, Switzerland