Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-30 @ 10:29 AM
Study NCT ID:
NCT01178034
Status:
COMPLETED
Last Update Posted:
2012-10-23
First Post:
2010-08-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Identification of Warfarin Maintenance Dosage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098434', 'term': 'Genetic Algorithms'}], 'ancestors': [{'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-21', 'studyFirstSubmitDate': '2010-08-06', 'studyFirstSubmitQcDate': '2010-08-06', 'lastUpdatePostDateStruct': {'date': '2012-10-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'International Normalized Ratio (INR)', 'timeFrame': 'Day 0, 5, 7, 9, 12, 15, 19.', 'description': 'Number of INR outside the therapeutic range (INR 2.0-3.0)'}], 'secondaryOutcomes': [{'measure': 'Number of changes in warfarin dosage', 'timeFrame': 'Day 0-19'}, {'measure': 'Difference between predicted and actual warfarin maintenance dose', 'timeFrame': 'Day 19'}, {'measure': 'Thromboembolic and Bleeding complications', 'timeFrame': 'Day 0-30'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Warfarin', 'Dose', 'Pharmacogenetic', 'INR'], 'conditions': ['Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '26710337', 'type': 'DERIVED', 'citation': 'Pengo V, Zambon CF, Fogar P, Padoan A, Nante G, Pelloso M, Moz S, Frigo AC, Groppa F, Bozzato D, Tiso E, Gnatta E, Denas G, Padayattil Jose S, Padrini R, Basso D, Plebani M. A Randomized Trial of Pharmacogenetic Warfarin Dosing in Naive Patients with Non-Valvular Atrial Fibrillation. PLoS One. 2015 Dec 28;10(12):e0145318. doi: 10.1371/journal.pone.0145318. eCollection 2015.'}]}, 'descriptionModule': {'briefSummary': 'Initiation of warfarin therapy is problematic. The investigators goal was to evaluate if a new demographic/pharmacogenetic algorithm is better than a usual algorithm based on INR value at day five after four days of 5 mg/day warfarin. To this end patients with atrial fibrillation starting warfarin are randomized in two arms.', 'detailedDescription': "The objective of this randomized study is to evaluate the accuracy of a new demographic/pharmacogenetic as compared to usual warfarin dosing algorithm in predicting warfarin maintenance dose. In patients with atrial fibrillation starting anticoagulation, the loading dose of warfarin in the tested group is calculated on the basis of VKORC1 genotype and patient's body weight.The second day warfarin maintenance dose is calculated on the basis of surface area and CYP2C9, CYP4F2 e VKORC1 genotype. In the usual care group the maintenance dose at day 5 is calculated on the basis of a published algorithm (Pengo V, Am J Cardiol 2001). INR is checked on day 0, 5, 7, 9, 12, 15 and 19. Primary end-point of the trial is the number of INR outside the therapeutic range of 2.0 to 3.0. Secondary end-points are the number of changes in dose prescription, the difference between predicted and actual warfarin maintenance dose and thrombotic and bleeding events."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>18 years\n* Indication to warfarin with INR between 2.0 and 3.0\n\nExclusion Criteria:\n\n* Pregnancy\n* Drug interactions\n* Basal INR \\> 1.2'}, 'identificationModule': {'nctId': 'NCT01178034', 'briefTitle': 'Early Identification of Warfarin Maintenance Dosage', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Early Identification of Warfarin Maintenance Dose in Patients With Atrial Fibrillation: a Randomized Trial Evaluating a New Genotype-based Versus Usual Care Initiation of Treatment', 'orgStudyIdInfo': {'id': '1643P'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pharmacogenetic warfarin dose', 'description': 'Warfarin maintenance dose on the basis of demographic/pharmacogenetic data', 'interventionNames': ['Genetic: Calculate warfarin dose using demographic/genetic algorithm']}], 'interventions': [{'name': 'Calculate warfarin dose using demographic/genetic algorithm', 'type': 'GENETIC', 'description': 'Age, body weight and genetic to calculate warfarin dosage', 'armGroupLabels': ['pharmacogenetic warfarin dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35128', 'city': 'Padua', 'country': 'Italy', 'facility': 'Thrombosis Centre', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Vittorio Pengo, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Padova'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Cardiology', 'investigatorFullName': 'Vittorio Pengo', 'investigatorAffiliation': 'University of Padova'}}}}