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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
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®.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epopoetinum beta | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methoxy-polyethyleneglycol epoetin beta | Drug | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Main Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthias Pfisterer, Prof. MD | University Hospital, Basel, Switzerland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Basel | Basel | 4031 | Switzerland |
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| ID | Term |
|---|---|
| C508420 | continuous erythropoietin receptor activator |
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|
| 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 |