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OpenTrials
Completed

NCT Number: NCT01093820

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

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

Completed

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University Hospital Basel

Basel, 4031, Switzerland

About this 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®.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: Mircera

Primary outcomes

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

    Time frame: three months

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

Secondary outcomes

  1. Maximal change in Hb within 3 months relative to baseline

    Time frame: three months

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

  2. Relative change in Hb from baseline to 1 months

    Time frame: first month

    measurement of Hb at baseline and month 1

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

    Time frame: three months

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

  4. change in platelet count within 3 months relative to baseline

    Time frame: three months

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

  5. Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures

    Time frame: three months

    follow-up at month 1, 2 and 3

  6. Relative change in Hb from 1 to 2 months

    Time frame: second month

    measurement of Hb at month 1 and 2

  7. Relative change in Hb from 2 to 3 months

    Time frame: third month

    measurement of Hb at month 2 and 3

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: BEATSTEMIPi

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 26, 2010
Registry last updated
Feb 29, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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