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

Acute Myocardial Infarction Clinical Trial

— BEATSTEMIPi  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093820
• Other study ID #: 2010 DR 2029
• Status: Completed
• Phase: Phase 2
• First received: March 16, 2010
• Last updated: February 28, 2012
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: February 2012
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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

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®.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: October 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Switzerland	University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Maximal change in Hb within 3 months relative to baseline	measurement of Hb at baseline and month 1, 2 and 3	three months	Yes
Secondary	Relative change in Hb from baseline to 1 months	measurement of Hb at baseline and month 1	first month	Yes
Secondary	Maximal change in Hematocrit (Hk) within 3 months relative to baseline	measurement of Hk at baseline and month 1, 2 and 3	three months	Yes
Secondary	change in platelet count within 3 months relative to baseline	measurement of platelet count at baseline and month 1, 2 and 3	three months	Yes
Secondary	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	Yes
Secondary	Relative change in Hb from 1 to 2 months	measurement of Hb at month 1 and 2	second month	Yes
Secondary	Relative change in Hb from 2 to 3 months	measurement of Hb at month 2 and 3	third month	Yes