Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT01093820
Status:
COMPLETED
Last Update Posted:
2012-02-29
First Post:
2010-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C508420', 'term': 'continuous erythropoietin receptor activator'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-02-28', 'studyFirstSubmitDate': '2010-03-16', 'studyFirstSubmitQcDate': '2010-03-25', 'lastUpdatePostDateStruct': {'date': '2012-02-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-03-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months', 'timeFrame': 'three months', 'description': 'measurement of Hb at baseline and month 1, 2 and 3'}], 'secondaryOutcomes': [{'measure': 'Maximal change in Hb within 3 months relative to baseline', 'timeFrame': 'three months', 'description': 'measurement of Hb at baseline and month 1, 2 and 3'}, {'measure': 'Relative change in Hb from baseline to 1 months', 'timeFrame': 'first month', 'description': 'measurement of Hb at baseline and month 1'}, {'measure': 'Maximal change in Hematocrit (Hk) within 3 months relative to baseline', 'timeFrame': 'three months', 'description': 'measurement of Hk at baseline and month 1, 2 and 3'}, {'measure': 'change in platelet count within 3 months relative to baseline', 'timeFrame': 'three months', 'description': 'measurement of platelet count at baseline and month 1, 2 and 3'}, {'measure': 'Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures', 'timeFrame': 'three months', 'description': 'follow-up at month 1, 2 and 3'}, {'measure': 'Relative change in Hb from 1 to 2 months', 'timeFrame': 'second month', 'description': 'measurement of Hb at month 1 and 2'}, {'measure': 'Relative change in Hb from 2 to 3 months', 'timeFrame': 'third month', 'description': 'measurement of Hb at month 2 and 3'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['acute myocardial infarction', 'continuous erythropoetin receptor activator', 'Mircera', 'hemoglobin kinetics'], 'conditions': ['Acute Myocardial Infarction']}, 'descriptionModule': {'briefSummary': 'Hypothesis:\n\nBased 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)\n\nDesign:\n\nProspective, open label single center pilot study', 'detailedDescription': '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®.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients (age 18 - 80 years) with acute STEMI undergoing PCI\n\nMain Exclusion Criteria:\n\n* Hemoglobin levels \\>15g/dL\n* history of a myeloproliferative syndrome\n* thrombolysis for index infarction\n* anticipated additional revascularization within 3 months\n* cardiogenic shock'}, 'identificationModule': {'nctId': 'NCT01093820', 'acronym': 'BEATSTEMIPi', 'briefTitle': 'Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Basel, Switzerland'}, 'officialTitle': 'Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)', 'orgStudyIdInfo': {'id': '2010 DR 2029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epopoetinum beta', 'description': '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', 'interventionNames': ['Drug: methoxy-polyethyleneglycol epoetin beta']}], 'interventions': [{'name': 'methoxy-polyethyleneglycol epoetin beta', 'type': 'DRUG', 'otherNames': ['Mircera'], 'description': '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', 'armGroupLabels': ['Epopoetinum beta']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'University Hospital Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}], 'overallOfficials': [{'name': 'Matthias Pfisterer, Prof. MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Basel, Switzerland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}