Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-29 @ 11:23 AM
Study NCT ID:
NCT01011504
Status:
COMPLETED
Last Update Posted:
2012-01-19
First Post:
2009-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Utilisation of Angiox® in European Practice
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060050', 'term': 'Angina, Stable'}, {'id': 'D000072658', 'term': 'Non-ST Elevated Myocardial Infarction'}, {'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D000787', 'term': 'Angina Pectoris'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002637', 'term': 'Chest Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2019}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-18', 'studyFirstSubmitDate': '2009-11-10', 'studyFirstSubmitQcDate': '2009-11-10', 'lastUpdatePostDateStruct': {'date': '2012-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-11-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Posology and usage patterns of Angiox®: Dose(s) and time of bolus and infusion administered', 'timeFrame': 'from hospital admission until hospital discharge, or 7 days after administration (which ever is earlier).'}], 'secondaryOutcomes': [{'measure': 'Death Myocardial infarction Unplanned revascularisation Stroke Major* and minor bleeding Thrombocytopenia Stent thrombosis Adverse events and serious adverse events', 'timeFrame': 'measured in-hospital (prior to discharge), and at post-hospital discharge in outpatient as per local practice (30 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Stable Angina (SA)', 'NSTE-ACS (NSTEMI and UA)', 'STEMI (STE-ACS)']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine utilisation patterns in patients receiving Angiox® in participating European centres. Additionally, through the collection of descriptive safety and outcomes data, this study will contribute to the Risk Management strategy for Europe'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately, 2,000 patients will be included at centres throughout Europe', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eligible for, and receive treatment with Angiox®.\n* Willing and able to provide written informed consent to the use of their data in accordance with relevant local Data Protection laws, policies and regulations\n\nExclusion Criteria:\n\n* Participation in other interventional clinical research studies involving the evaluation of investigational drugs, including Angiox®, or devices at the time of enrolment.\n* Patients not eligible for treatment for Angiox®.'}, 'identificationModule': {'nctId': 'NCT01011504', 'acronym': 'EURO-vision', 'briefTitle': 'Utilisation of Angiox® in European Practice', 'organization': {'class': 'INDUSTRY', 'fullName': 'The Medicines Company'}, 'officialTitle': 'A Registry Study to Determine Utilisation Patterns in Patients Receiving Angiox®, and Collect Descriptive Safety and Outcome Data to Inform the Risk Management Strategy for Europe.', 'orgStudyIdInfo': {'id': 'TMC-BIV-08-02'}}, 'contactsLocationsModule': {'locations': [{'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire de Caen', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': 'D-18057', 'city': 'Rostock', 'country': 'Germany', 'facility': 'Medizinische Klinik I Kardiologie/Pneumologie/Internistische', 'geoPoint': {'lat': 54.0887, 'lon': 12.14049}}], 'overallOfficials': [{'name': 'Christoph Nienaber, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Martial Hamon, Prof', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Medicines Company', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}