Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-04-04 @ 2:39 AM
Study NCT ID:
NCT02069132
Status:
UNKNOWN
Last Update Posted:
2017-04-27
First Post:
2014-02-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity
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': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 376}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-04-26', 'studyFirstSubmitDate': '2014-02-20', 'studyFirstSubmitQcDate': '2014-02-20', 'lastUpdatePostDateStruct': {'date': '2017-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-02-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients whose predicted dose of warfarin is within 20% of the actual stable therapeutic dose.', 'timeFrame': 'up to 12 months', 'description': "stable warfarin dosing is defined as the mean daily does required to achieve three or more consecutive International Normalized Ratio (INR) measurements within the individual's target range, at the same daily does."}], 'secondaryOutcomes': [{'measure': 'Percentage of patients for whom the predicted dose is at least 20% higher than the actual dose (overestimation) or at least 20% lower than the actual dose (underestimation).', 'timeFrame': 'up to 12 months'}, {'measure': 'number of cardiovascular and cerebrovascular events', 'timeFrame': '12 months', 'description': 'composite endpoint: death for any cause, hospitalization for cardiovascular and cerebrovascular events, major bleeding or thromboembolism'}, {'measure': 'number of patients with major bleeding events', 'timeFrame': '12 months', 'description': 'major bleeding: (i) fatal bleeding; and/or (ii) symptomatic bleeding in a critical area or organ; and/or (iii) bleeding causing a fall in haemoglobin level of ≥2 g/dL or leading to transfusion of two or more units of blood or red cells.'}, {'measure': 'number of thromboembolic event', 'timeFrame': '12 months', 'description': 'thromboembolism is defined as occurrence of cerebral infarction, myocardial infarction, peripheral arterial embolism.'}, {'measure': 'number of cardiovascular and cerebrovascular events', 'timeFrame': '4 weeks'}, {'measure': 'number of patient reported episodes of minor bleeding events', 'timeFrame': 'one year'}, {'measure': 'average maintenance dose per patient', 'timeFrame': '12 months'}, {'measure': 'time to achievement of stable warfarin dosing from initiation', 'timeFrame': 'up to 12 months'}, {'measure': 'time to therapeutic INR per patient', 'timeFrame': 'up to 12 months', 'description': "defined as the time of first achieving INR measurement within the individual's target range, providing that INR is also within the target range at the subsequent clinic visit"}, {'measure': 'percentage time in the therapeutic INR range', 'timeFrame': 'up to 3 months'}, {'measure': 'percentage time in the therapeutic INR range', 'timeFrame': 'four weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Warfarin', 'International Warfarin Pharmacogenetics Consortium algorithm', 'Atrial Fibrillation', 'Heart Valve Prosthesis Implantation', 'elderly', 'comorbidity'], 'conditions': ['Atrial Fibrillation', 'Thrombus Due to Heart Valve Prosthesis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to validate the International Warfarin Pharmacogenetics Consortium (IWPC) algorithm in a prospective cohort of elderly people (65 years or older) with heart valves and/or nonvalvular atrial fibrillation (AF) and at least one comorbid condition, and to assess the algorithm's prognostic relevance."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'prospective cohort of elderly people (≥65 years) with nonvalvular atrial fibrillation and/or heart valve replacement, with at least one comorbid condition, presenting for warfarin therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 65 years\n* Patients who initiate warfarin because of non valvular atrial fibrillation or heart valve replacement\n* At least one comorbid condition\n* At least two other drugs regularly assumed over and above warfarin\n\nExclusion Criteria:\n\n* Presence of systemic coagulopathies\n* Presence of malignancies needing chemotherapy\n* Inability or refusal to give informed consent'}, 'identificationModule': {'nctId': 'NCT02069132', 'acronym': 'VIALE', 'briefTitle': 'Validation of International Warfarin Pharmacogenetics Consortium (IWPC) Algorithm in Elderly Patients With Comorbidity', 'organization': {'class': 'OTHER', 'fullName': 'University of Campania Luigi Vanvitelli'}, 'officialTitle': 'Prospective Validation of IWPC Pharmacogenetic Algorithm for Estimating the Appropriate Initial Dose of Warfarin in Elderly People (65 or Older) With Heart Valves Prostheses or Non Valvular Atrial Fibrillation and Comorbidity', 'orgStudyIdInfo': {'id': 'VIALE'}, 'secondaryIdInfos': [{'id': 'FARM9JNT9Y', 'type': 'OTHER_GRANT', 'domain': 'Agenzia Italiana per il Farmaco (AIFA)'}, {'id': '2012-002578-30', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Warfarin in elderly with comorbidity', 'description': 'Patients 65 years or older, candidate for therapy with warfarin for non valvular atrial fibrillation or heart valve replacement', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'description': 'warfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment.', 'armGroupLabels': ['Warfarin in elderly with comorbidity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Napoli', 'country': 'Italy', 'facility': 'Second University of Naples', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Napoli', 'country': 'Italy', 'facility': 'University of Naples Federico II', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}, {'city': 'Salerno', 'country': 'Italy', 'facility': 'University of Salerno', 'geoPoint': {'lat': 40.67545, 'lon': 14.79328}}], 'overallOfficials': [{'name': 'Ciro Gallo, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Campania Luigi Vanvitelli'}, {'name': 'Amelia Filippelli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Salerno'}, {'name': 'Marisa De Feo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Campania Luigi Vanvitelli'}, {'name': 'Nicola Ferrara, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federico II University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campania Luigi Vanvitelli', 'class': 'OTHER'}, 'collaborators': [{'name': 'Federico II University', 'class': 'OTHER'}, {'name': 'University of Salerno', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medical Statistics', 'investigatorFullName': 'Ciro Gallo', 'investigatorAffiliation': 'University of Campania Luigi Vanvitelli'}}}}