Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEATSTEMIPi)
This study has been completed.
Sponsor:
University Hospital, Basel, Switzerland
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier:
NCT01093820
First received: March 16, 2010
Last updated: February 28, 2012
Last verified: February 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Myocardial Infarction |
Drug: methoxy-polyethyleneglycol epoetin beta |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot) |
Resource links provided by NLM:
Further study details as provided by University Hospital, Basel, Switzerland:
Primary Outcome Measures:
- Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months [ Time Frame: three months ] [ Designated as safety issue: Yes ]measurement of Hb at baseline and month 1, 2 and 3
Secondary Outcome Measures:
- Maximal change in Hb within 3 months relative to baseline [ Time Frame: three months ] [ Designated as safety issue: Yes ]measurement of Hb at baseline and month 1, 2 and 3
- Relative change in Hb from baseline to 1 months [ Time Frame: first month ] [ Designated as safety issue: Yes ]measurement of Hb at baseline and month 1
- Maximal change in Hematocrit (Hk) within 3 months relative to baseline [ Time Frame: three months ] [ Designated as safety issue: Yes ]measurement of Hk at baseline and month 1, 2 and 3
- change in platelet count within 3 months relative to baseline [ Time Frame: three months ] [ Designated as safety issue: Yes ]measurement of platelet count at baseline and month 1, 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 [ Time Frame: three months ] [ Designated as safety issue: Yes ]follow-up at month 1, 2 and 3
- Relative change in Hb from 1 to 2 months [ Time Frame: second month ] [ Designated as safety issue: Yes ]measurement of Hb at month 1 and 2
- Relative change in Hb from 2 to 3 months [ Time Frame: third month ] [ Designated as safety issue: Yes ]measurement of Hb at month 2 and 3
| Enrollment: | 8 |
| Study Start Date: | April 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Epopoetinum 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
|
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
Other Name: Mircera
|
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®.
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01093820
Locations
| Switzerland | |
| University Hospital Basel | |
| Basel, Switzerland, 4031 | |
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
| Principal Investigator: | Matthias Pfisterer, Prof. MD | University Hospital, Basel, Switzerland |
More Information
No publications provided
| Responsible Party: | University Hospital, Basel, Switzerland |
| ClinicalTrials.gov Identifier: | NCT01093820 History of Changes |
| Other Study ID Numbers: | 2010 DR 2029 |
| Study First Received: | March 16, 2010 |
| Last Updated: | February 28, 2012 |
| Health Authority: | Switzerland: Swissmedic |
Keywords provided by University Hospital, Basel, Switzerland:
|
acute myocardial infarction continuous erythropoetin receptor activator Mircera hemoglobin kinetics |
Additional relevant MeSH terms:
|
Myocardial Infarction Infarction Myocardial Ischemia Heart Diseases Cardiovascular Diseases |
Vascular Diseases Ischemia Pathologic Processes Necrosis |
ClinicalTrials.gov processed this record on May 21, 2013