Ignite Creation Date:
2025-12-24 @ 10:45 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT00162435
Status:
UNKNOWN
Last Update Posted:
2018-06-12
First Post:
2005-09-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Genetic Determinants of Warfarin Anticoagulation Effect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D011655', 'term': 'Pulmonary Embolism'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart 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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-11', 'studyFirstSubmitDate': '2005-09-11', 'studyFirstSubmitQcDate': '2005-09-11', 'lastUpdatePostDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic end points:', 'timeFrame': '1-4 months'}, {'measure': 'Warfarin clearance and formation clearance of 7-hydroxy-warfarin at steady state', 'timeFrame': '1-4 months'}, {'measure': 'Pharmacodynamic.', 'timeFrame': '1-4 months'}, {'measure': 'Maintenance dose of warfarin at steady state.', 'timeFrame': '1-4 months'}, {'measure': 'Time to reach INR > 2.', 'timeFrame': '1-4 months'}, {'measure': 'Time to reach pharmacodynamic steady state.', 'timeFrame': '1-4 months'}, {'measure': 'Time spent at therapeutic INR <3 and >2.', 'timeFrame': '1-4 months'}, {'measure': 'Time spent at INR >3.', 'timeFrame': '1-4 months'}, {'measure': 'Time spent at INR <2.', 'timeFrame': '1-4 months'}, {'measure': 'The incidence of minor and major bleeding episodes.', 'timeFrame': '1-4 months'}]}, 'conditionsModule': {'conditions': ['Venous Thrombosis', 'Pulmonary Embolism', 'Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '17851566', 'type': 'DERIVED', 'citation': 'Caraco Y, Blotnick S, Muszkat M. CYP2C9 genotype-guided warfarin prescribing enhances the efficacy and safety of anticoagulation: a prospective randomized controlled study. Clin Pharmacol Ther. 2008 Mar;83(3):460-70. doi: 10.1038/sj.clpt.6100316. Epub 2007 Sep 12.'}]}, 'descriptionModule': {'briefSummary': "The response to warfarin varies greatly among individuals. Some of this variability can be ascribed to genetic polymorphisms in the gene encoding for CYP2C9, the enzyme mediating the metabolism of S warfarin. In addition genetic polymorphism in other genes (i.e. VKORC1, factor VII) have been shown to account for some of the variability in the response to warfarin irrespective of CYP2C9.The present study has several segments:\n\n1. Evaluation of the relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin maintenance dose at steady state. This study is a confirmation of previous data in our own population.\n2. Evaluation of relationship between genetic polymorphisms in the genes encoding for CYP2C9, VKORC1 and factor VII and warfarin loading dose during the induction period.\n3. Testing the hypothesis that warfarin loading based on the individual's combined CYP2C9, VKORC1 and factor VII genotype may be more efficient and associated with reduced adverse drug effects."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in whom warfarin is about to be initiated\n* Desired therapeutic range \\>2 and \\<3\n\nExclusion Criteria:\n\n* Refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT00162435', 'briefTitle': 'Genetic Determinants of Warfarin Anticoagulation Effect', 'organization': {'class': 'OTHER', 'fullName': 'Hadassah Medical Organization'}, 'officialTitle': 'Warfarin Induction Regimen Based Upon CYP2C9, VKORC1 Factor VII Genotyping, PMR and INR Monitoring, as Compared to the Conventional Regimen: a Prospective Controlled Study', 'orgStudyIdInfo': {'id': 'yc19553-HMO-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Genetic', 'interventionNames': ['Drug: Warfarin']}, {'type': 'EXPERIMENTAL', 'label': 'Control', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'armGroupLabels': ['Control', 'Genetic']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jerusalem', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Arik Tzukert, DMD', 'role': 'CONTACT', 'email': 'arik@hadassah.org.il', 'phone': '00 972 2 6776095'}, {'name': 'Hadas Lemberg, PhD', 'role': 'CONTACT', 'email': 'lhadas@hadassah.org.il', 'phone': '00 972 2 6777572'}, {'name': 'Yoseph Caraco, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hadassah Medical Organization', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}], 'centralContacts': [{'name': 'Yoseph Caraco, MD', 'role': 'CONTACT', 'email': 'caraco@hadassah.org.il', 'phone': '00 972 2 6778584'}], 'overallOfficials': [{'name': 'Yoseph Caraco, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hadassah Medical Organization'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hadassah Medical Organization', 'class': 'OTHER'}, 'collaborators': [{'name': 'United States - Israel Binational Science Foundation', 'class': 'OTHER'}, {'name': 'Israel Science Foundation', 'class': 'OTHER'}, {'name': 'Ministry of Health, Israel', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}