Acute Myocardial Infarction
Conditions
Keywords
acute myocardial infarction, continuous erythropoetin receptor activator, Mircera, hemoglobin kinetics
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®.
Interventions
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
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Relative change in Hb from baseline to 1 months | first month | measurement of Hb at baseline and month 1 |
| 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 |
| 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 1 to 2 months | second month | measurement of Hb at month 1 and 2 |
| Relative change in Hb from 2 to 3 months | third month | measurement of Hb at month 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 |
Countries
Switzerland
Outcome results
None listed