Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-26 @ 1:55 AM
Study NCT ID:
NCT01269905
Status:
COMPLETED
Last Update Posted:
2011-01-04
First Post:
2011-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2005-01', 'lastUpdateSubmitDate': '2011-01-03', 'studyFirstSubmitDate': '2011-01-03', 'studyFirstSubmitQcDate': '2011-01-03', 'lastUpdatePostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Anticoagulation', 'Mechanical Heart Valve Replacement']}, 'descriptionModule': {'briefSummary': 'The optimal valve substitute for patients between 60-70 years is controversial. We compared anticoagulation-related adverse events (ARAE) in patients receiving mechanical heart valve replacement (MHVR) on INR self-management vs. stentless bioprosthesis, to assess whether the risk of structural valve deterioration (SVD) is still out-weighted by the benefit of not requiring permanent anticoagulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients received heart valve replacement and were retrospectively allocated in three groups', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* heart valve replacement\n\nExclusion Criteria:\n\n* CABG\n* Afib'}, 'identificationModule': {'nctId': 'NCT01269905', 'briefTitle': 'Choice of Valve Substitute in the Era of Oral Anticoagulation Self-Management', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'orgStudyIdInfo': {'id': 'COAG-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A', 'description': 'Group A patients received mechanical heart valve replacement MHVR (and were educated in INR self-management using the Coagu-Check monitor.'}, {'label': 'Group B', 'description': 'Group B patients received MHVR and their anticoagulation was managed by their general practitioners.'}, {'label': 'Group C', 'description': 'Group C patients received stentless bioprosthesis, with initial 6 weeks on oral anticoagulation managed by their general practitioners.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}}}}