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

Study Overview
=================
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®.

Official Title
-----------------
Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: methoxy-polyethyleneglycol epoetin beta


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epopoetinum beta<br>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<br>* 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<br>* Other names: Mircera;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months | measurement of Hb at baseline and month 1, 2 and 3 | three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal change in Hb within 3 months relative to baseline | measurement of Hb at baseline and month 1, 2 and 3 | three months | 
| Relative change in Hb from baseline to 1 months | measurement of Hb at baseline and month 1 | first month | 
| Maximal change in Hematocrit (Hk) within 3 months relative to baseline | measurement of Hk at baseline and month 1, 2 and 3 | three months | 
| change in platelet count within 3 months relative to baseline | measurement of platelet count at baseline and month 1, 2 and 3 | three months | 
| Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures | follow-up at month 1, 2 and 3 | three months | 
| Relative change in Hb from 1 to 2 months | measurement of Hb at month 1 and 2 | second month | 
| Relative change in Hb from 2 to 3 months | measurement of Hb at month 2 and 3 | third month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acute myocardial infarction, continuous erythropoetin receptor activator, Mircera, hemoglobin kinetics