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

NCT01093820 | Completed Phase 2 DMC

• 1 other identifier: 2010 DR 2029
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myocardial Infarction

Keywords

acute myocardial infarction; continuous erythropoetin receptor activator; Mircera; hemoglobin kinetics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Maximal change in Hb within 3 months relative to baseline

  three months

• Relative change in Hb from baseline to 1 months

  first month

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

  three months

• change in platelet count within 3 months relative to baseline

  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

  three months

Study Arms (1)

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

Drug: methoxy-polyethyleneglycol epoetin beta

Interventions

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

Also known as: Mircera

Epopoetinum beta

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients (age 18 - 80 years) with acute STEMI undergoing PCI

You may not qualify if:

• Hemoglobin levels \>15g/dL
• history of a myeloproliferative syndrome
• thrombolysis for index infarction
• anticipated additional revascularization within 3 months
• cardiogenic shock

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Interventions

continuous erythropoietin receptor activator

Study Officials

• Matthias Pfisterer, Prof. MD

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2010
• First Posted: March 26, 2010
• Study Start: April 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: October 1, 2010
• Last Updated: February 29, 2012

Record last verified: 2012-02

Locations

CH (1)