Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:57 AM
Study NCT ID:
NCT00468702
Status:
WITHDRAWN
Last Update Posted:
2016-11-02
First Post:
2007-05-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2007-05-02', 'studyFirstSubmitQcDate': '2007-05-02', 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-05-03', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Cardiovascular Abnormalities']}, 'descriptionModule': {'briefSummary': 'This study will measure the efficacy and safety of an early postoperative anticoagulation self-management program, using the CoaguChek S device, in patients undergoing mechanical valve replacements. Patients will be randomized into a study group (self-management) or a control group (physician management).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult patients, 18-70 years of age;\n* recipient of a mechanical heart valve (aortic and/or mitral), +/- CABG, +/- postoperative atrial fibrillation.\n\nExclusion Criteria:\n\n* recipient of a bioprosthetic valve;\n* post-operative thrombotic events;\n* pre-operative utilization of oral anticoagulation.'}, 'identificationModule': {'nctId': 'NCT00468702', 'briefTitle': 'Postoperative Canadian Oral Anticoagulation Self-management (Post-COAGS) Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Postoperative Canadian Oral Anticoagulation Self-Management (Post-COAGS) Trial', 'orgStudyIdInfo': {'id': 'RD-0014'}, 'secondaryIdInfos': [{'id': 'RD000000383-2007'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'CoaguChek S', 'type': 'DEVICE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ottawa', 'country': 'Canada', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hoffmann-La Roche', 'class': 'INDUSTRY'}}}}