Ignite Creation Date:
2025-12-26 @ 12:18 PM
Ignite Modification Date:
2026-01-01 @ 2:01 AM
Study NCT ID:
NCT03962400
Status:
WITHDRAWN
Last Update Posted:
2022-03-04
First Post:
2019-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reinforcement Learning for Warfarin Dosing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020141', 'term': 'Hemostatic Disorders'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000098408', 'term': 'Reinforcement Machine Learning'}], 'ancestors': [{'id': 'D000069550', 'term': 'Machine Learning'}, {'id': 'D001185', 'term': 'Artificial Intelligence'}, {'id': 'D000465', 'term': 'Algorithms'}, {'id': 'D055641', 'term': 'Mathematical Concepts'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Subjects will not be informed of group designation'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Controlled Trial of 2 groups. Subjects in the Control group will receive warfarin with dose adjustment guided by standard protocol. Subjects in the Treatment group will receive warfarin with dose adjustment guided by personalized protocol.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'The study did not receive anticipated funding and therefore never opened to enrollment. The study was never submitted to the IRB for approval since the funding failed.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-01-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-02-17', 'studyFirstSubmitDate': '2019-05-21', 'studyFirstSubmitQcDate': '2019-05-23', 'lastUpdatePostDateStruct': {'date': '2022-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percent in Range', 'timeFrame': '6 months', 'description': 'Percent of INR measurements within the Target Range'}], 'secondaryOutcomes': [{'measure': 'Adverse Events', 'timeFrame': '6 Months', 'description': 'Composite of all adverse events attributed to warfarin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['warfarin'], 'conditions': ['Clotting Disorder']}, 'descriptionModule': {'briefSummary': 'This is a clinical study designed to test the hypothesis that a computer model for dosing warfarin is superior to current clinical practice. Subjects will be randomized to two groups based on how warfarin dose is determined and followed for 6 months. The primary outcome is the percent of the time that the INR is maintained in the effective range.', 'detailedDescription': 'This will be a single-center, open-label, randomized prospective study. Primary outcome will be percent of time within a specific INR range. Subjects will be randomized to to control and treatment groups and stratified 1:1 based on sex. The control group will have warfarin doses adjusted by experts in the treatment of patients with warfarin. The treatment group will have warfarin doses determined using a clinical support tool based on reinforcement learning. Based on simulations of the experimental design with an expectation that the percent of INR values within the target range increase by 20%, 70 subjects per group are required for statistical significance. Based on an attrition rate of 15%, the investigators will enroll 80 subjects per group. Statistical analysis will compare the percent of patients within the target INR range between groups as the primary outcome with number of adverse events between groups as the safetly outcome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Receiving anticoagulation treatment with warfarin.\n\nExclusion Criteria:\n\n* Pregnancy.\n\n * History of hemorrhagic cerebrovascular incident.\n * Acquired or inherited hemophilia.\n * Thrombocytopenia (\\<100,000 platelets per mm3) on 2 occasions separated by 2 days.\n * Anemia with hemoglobin concentration \\< 10 g/dL.\n * Active cancer excluding non-melanoma skin cancers.\n * Active liver disease as documented by prolonged baseline INR ≥ 1.6.\n * Uncontrolled hypertension with 2 readings \\>180/110.\n * Recent (\\< 2 weeks) neurosurgical procedure.\n * Enrollment in hospice program for any diagnosis.'}, 'identificationModule': {'nctId': 'NCT03962400', 'briefTitle': 'Reinforcement Learning for Warfarin Dosing', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Randomized Trial of Reinforcement Learning for the Dosing of Warfarin', 'orgStudyIdInfo': {'id': 'KDP002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Subjects will have warfarin dose determined in the usual fashion by a health care provider.', 'interventionNames': ['Procedure: Heath Care Provider']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'Subjects will have warfarin dose determined using a reinforcement learning computer model.', 'interventionNames': ['Procedure: Reinforcement Learning']}], 'interventions': [{'name': 'Reinforcement Learning', 'type': 'PROCEDURE', 'description': 'New computer based procedure for determining dose using a decision support tool', 'armGroupLabels': ['Treatment']}, {'name': 'Heath Care Provider', 'type': 'PROCEDURE', 'description': 'Warfarin dose will be determined by a qualified health care provider', 'armGroupLabels': ['Control']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Adam Edward Gaweda', 'investigatorAffiliation': 'University of Louisville'}}}}