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

University Hospital, Basel, Switzerland8 enrolled

Overview

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®.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Myocardial Infarction

Interventions

methoxy-polyethyleneglycol epoetin betaDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

University Hospital Basel

Basel, Switzerland

Outcomes

Primary Outcomes

Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months

measurement of Hb at baseline and month 1, 2 and 3

Time frame: three months

Secondary Outcomes

Maximal change in Hb within 3 months relative to baseline

measurement of Hb at baseline and month 1, 2 and 3

Time frame: three months

Relative change in Hb from baseline to 1 months

measurement of Hb at baseline and month 1

Time frame: first month

Maximal change in Hematocrit (Hk) within 3 months relative to baseline

measurement of Hk at baseline and month 1, 2 and 3

Time frame: three months

change in platelet count within 3 months relative to baseline

measurement of platelet count at baseline and month 1, 2 and 3

Time frame: 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

Time frame: three months

Relative change in Hb from 1 to 2 months

measurement of Hb at month 1 and 2

Time frame: second month

Relative change in Hb from 2 to 3 months

measurement of Hb at month 2 and 3

Data from ClinicalTrials.gov

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