Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01042067
Status:
SUSPENDED
Last Update Posted:
2011-04-27
First Post:
2010-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safer Warfarin Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'whyStopped': 'Enrolling participants has halted due to lack of investigator.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'lastUpdateSubmitDate': '2011-04-26', 'studyFirstSubmitDate': '2010-01-04', 'studyFirstSubmitQcDate': '2010-01-04', 'lastUpdatePostDateStruct': {'date': '2011-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-05', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['warfarin', 'genotyping', 'vitamin K', 'dosing', 'adverse events', 'initial phase of treatment', 'algorithm'], 'conditions': ['Atrial Fibrillation', 'Venous Thrombosis', 'Pulmonary Embolism', 'Heart Valve Prosthesis']}, 'descriptionModule': {'briefSummary': 'The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment. About 200 patients will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian\n* \\>18 years of age\n* included in the study at the onset of warfarin treatment\n* target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves)\n* standard indications for warfarin treatment\n\nExclusion Criteria:\n\n* Non-caucasian\n* Clinical significant liver affection\n* Heart failure, NYHA class III-IV\n* Non-compliant - not able to accomplish protocol demands\n* Not able to give informed consent\n* Long-term antibiotic therapy\n* Malabsorption conditions and inflammatory bowel disease'}, 'identificationModule': {'nctId': 'NCT01042067', 'acronym': 'CYKOWAR', 'briefTitle': 'Safer Warfarin Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Safer Warfarin Treatment - the Influence of CYP2C9 Genotyping, Genotyping of Vitamine K Dependent Proteins and Dietary Vitamine K Status on Dosing, Clinical Effect and Adverse Events With Emphasis on the Initial Phase of Treatment', 'orgStudyIdInfo': {'id': '2006-001895-18'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Warfarin treatment group', 'description': 'Open label study. Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment.', 'interventionNames': ['Other: Blood specimens (whole blood, serum, plasma)']}], 'interventions': [{'name': 'Blood specimens (whole blood, serum, plasma)', 'type': 'OTHER', 'description': 'The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.', 'armGroupLabels': ['Warfarin treatment group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N-0407', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Oslo', 'class': 'OTHER'}, {'name': 'Norwegian Medicines Agency', 'class': 'OTHER_GOV'}, {'name': 'Norway: South-Eastern Norway Regional Health Authority', 'class': 'UNKNOWN'}]}}}