Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-03-10 @ 8:48 PM
Study NCT ID:
NCT01996657
Status:
COMPLETED
Last Update Posted:
2017-06-26
First Post:
2013-11-04
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'zhengleetau@qq.com', 'phone': '+862765796888', 'title': 'Dr.Litao Zhang', 'phoneExt': '8204', 'organization': 'Wuhan Asia Heart Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Standard Intensity of Anticoagulation', 'description': 'After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).\n\nWarfarin', 'otherNumAtRisk': 245, 'deathsNumAtRisk': 245, 'otherNumAffected': 0, 'seriousNumAtRisk': 245, 'deathsNumAffected': 12, 'seriousNumAffected': 24}, {'id': 'EG001', 'title': 'D-dimer-guided Adjustmentd of Anticoagutlation Intensity', 'description': 'The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.\n\nWarfarin', 'otherNumAtRisk': 245, 'deathsNumAtRisk': 245, 'otherNumAffected': 0, 'seriousNumAtRisk': 245, 'deathsNumAffected': 4, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'Low Intensity Without Adjustment', 'description': 'The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),\n\nWarfarin', 'otherNumAtRisk': 242, 'deathsNumAtRisk': 242, 'otherNumAffected': 0, 'seriousNumAtRisk': 242, 'deathsNumAffected': 5, 'seriousNumAffected': 20}], 'seriousEvents': [{'term': 'thrombotic envents', 'notes': 'including valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 14}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bleeding events', 'notes': 'including cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Deaths from other causes', 'notes': 'Death from Heart failure,Cancer or unexplained death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 245, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 242, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Bleeding Events;', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Intensity of Anticoagulation', 'description': 'After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).\n\nWarfarin'}, {'id': 'OG001', 'title': 'Low Intensity and Adjusted by Elevated D-dimer', 'description': 'The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.\n\nWarfarin'}, {'id': 'OG002', 'title': 'Low Intensity Without Adjustment', 'description': 'The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),\n\nWarfarin'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Thrombotic Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Intensity of Anticoagulation', 'description': 'After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).\n\nWarfarin'}, {'id': 'OG001', 'title': 'Low Intensity and Adjusted by Elevated D-dimer', 'description': 'The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.\n\nWarfarin'}, {'id': 'OG002', 'title': 'Low Intensity Without Adjustment', 'description': 'The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),\n\nWarfarin'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '24 months', 'description': 'The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'All Cause Deaths', 'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'OG000'}, {'value': '239', 'groupId': 'OG001'}, {'value': '234', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Standard Intensity of Anticoagulation', 'description': 'After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).\n\nWarfarin'}, {'id': 'OG001', 'title': 'Low Intensity and Adjusted by Elevated D-dimer', 'description': 'The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.\n\nWarfarin'}, {'id': 'OG002', 'title': 'Low Intensity Without Adjustment', 'description': 'The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),\n\nWarfarin'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 24 months', 'description': 'The deaths from all causes', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Standard Intensity of Anticoagulation', 'description': 'After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).\n\nWarfarin'}, {'id': 'FG001', 'title': 'Low Intensity and Adjusted by Elevated D-dimer', 'description': 'The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.\n\nWarfarin'}, {'id': 'FG002', 'title': 'Low Intensity Without Adjustment', 'description': 'The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),\n\nWarfarin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '250'}, {'groupId': 'FG001', 'numSubjects': '250'}, {'groupId': 'FG002', 'numSubjects': '248'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '237'}, {'groupId': 'FG001', 'numSubjects': '239'}, {'groupId': 'FG002', 'numSubjects': '234'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '237', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '234', 'groupId': 'BG002'}, {'value': '710', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Standard Intensity of Anticoagulation', 'description': 'After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).\n\nWarfarin'}, {'id': 'BG001', 'title': 'Low Intensity and Adjusted by Elevated D-dimer', 'description': 'The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.\n\nWarfarin'}, {'id': 'BG002', 'title': 'Low Intensity Without Adjustment', 'description': 'The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),\n\nWarfarin'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.8', 'spread': '11.5', 'groupId': 'BG000'}, {'value': '50.4', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '50.1', 'spread': '10.9', 'groupId': 'BG002'}, {'value': '49.8', 'spread': '11.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '96', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}, {'value': '399', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Elevated D-dimer(n)', 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '91', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Plasma'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 772}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-09', 'studyFirstSubmitDate': '2013-11-04', 'resultsFirstSubmitDate': '2017-04-09', 'studyFirstSubmitQcDate': '2013-11-21', 'lastUpdatePostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-04-09', 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Bleeding Events;', 'timeFrame': 'Up to 24 months', 'description': 'The bleeding events included cerebral hemorrhage, gastrointestinal bleeding and other major internal or external bleeding that causes death, hospitalization, or permanent injury (e.g. vision loss) or necessitates transfusion.'}, {'measure': 'Thrombotic Events', 'timeFrame': '24 months', 'description': 'The thrombotic events included valve thrombosis, transient ischemic attack, ischemic stroke, peripheral embolism, and myocardial infarction.'}], 'secondaryOutcomes': [{'measure': 'All Cause Deaths', 'timeFrame': 'Up to 24 months', 'description': 'The deaths from all causes'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['mechanical valves replacement', 'INR', 'D-dimer', 'thromboembolic events'], 'conditions': ['Heart Valve Disease']}, 'referencesModule': {'references': [{'pmid': '31019170', 'type': 'DERIVED', 'citation': 'Zhang L, Long Y, Xiao H, Yang J, Liu X, Zhang Z. D-Dimer to Predict the Clinical Outcomes in Patients with Mechanical Heart Valve Replacement During Oral Anticoagulation Therapy. Int Heart J. 2019 May 30;60(3):631-636. doi: 10.1536/ihj.18-237. Epub 2019 Apr 25.'}, {'pmid': '28762606', 'type': 'DERIVED', 'citation': 'Zhang L, Zheng X, Long Y, Wu M, Chen Y, Yang J, Liu Z, Zhang Z. D-dimer to guide the intensity of anticoagulation in Chinese patients after mechanical heart valve replacement: a randomized controlled trial. J Thromb Haemost. 2017 Oct;15(10):1934-1941. doi: 10.1111/jth.13782. Epub 2017 Sep 20.'}]}, 'descriptionModule': {'briefSummary': 'The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.\n\nThis study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.', 'detailedDescription': 'Background: The optimal intensity of oral anticoagulation in China patients undergoing mechanical valve replacements is still controversial due to the different risk profiles of thrombophilia and bleeding in Chinese patients. Elevated D-dimer could reflect a pro-thrombogenic or prothrombotic state, and thus might be used to decide the intensity of oral anticoagulation.\n\nObjective: This study was to evaluate whether elevated D-dimer levels could help to determine the intensity of oral anticoagulation in patients with mechanical heart valve prostheses.\n\nMethods: A single-center, prospective study was performed. 748 Patients with mechanical valve replacement who had received oral anticoagulation. The patients were randomly assigned to three groups The intensity of anticoagulation for group one was standard intensity (INR:2.5-3.5). The intensity of anticoagulation for group two was kept at low intensity without adjustment (INR:1.8-2.6), and for group three , The intensity of anticoagulation maintained at low level initiatively (INR:1.8-2.6), D-dimer testing were analyzed two times at 3 month later. In case of D-dimer level elevated, adjusted the intensity of anticoagulation to standard level. The endpoint of the study was the subsequent thromboembolic and major bleeding during an average follow-up of 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients suffered mechanical valves replacement because of valves dysfunction; and oral anticoagulation therapy with warfarin', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. age\\>18years,male or female without pregnancy;\n2. Suffered the mechanical valves replacement in Wuhan Asia Heart Hospital;\n3. The operation type was Mitral valve replacement or Double valves replacement(aortic and mitral valve replacement).\n\nExclusion Criteria: Patients with following diseases within 3 months.\n\n1. deep venous thromboembolism\n2. Pulmonary embolism\n3. Aortic dissection\n4. stroke\n5. Cerebral hemorrhage\n6. Myocardial infarction'}, 'identificationModule': {'nctId': 'NCT01996657', 'acronym': '3D-INTENSITY', 'briefTitle': 'D-Dimer Determined Anticoagulation INTENSITY in Patients With Mechanical Valve Replacement', 'organization': {'class': 'OTHER', 'fullName': 'Wuhan Asia Heart Hospital'}, 'officialTitle': 'D-dimer Levels Determined the Intensity of Anticoagulation Therapy to Improve Outcomes in Patients With Mechanical Valve Replacement', 'orgStudyIdInfo': {'id': '2013-P-002'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Standard intensity of anticoagulation', 'description': 'After mechanical valve replacement，patients should be gave oral anticoagulants，such as warfarin.and The intensity of anticoagulation for this group was standard intensity (INR:2.5-3.5).', 'interventionNames': ['Drug: Warfarin']}, {'label': 'Low intensity and adjusted by elevated D-dimer', 'description': 'The intensity of anticoagulation maintained at low level initiatively, D-dimer testing were analyzed at 3 month later. In case of D-dimer level elevated, adjusted the intensity to standard level.', 'interventionNames': ['Drug: Warfarin']}, {'label': 'Low intensity without adjustment', 'description': 'The intensity of anticoagulation for this group was kept at low intensity without adjustment (INR:1.8-2.6),', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'Warfarin', 'type': 'DRUG', 'otherNames': ['Warfarin Sodium Tablets'], 'armGroupLabels': ['Low intensity and adjusted by elevated D-dimer', 'Low intensity without adjustment', 'Standard intensity of anticoagulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'WAHH', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'zip': '430022', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Wuhan Asia Heart Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'zhang zhenlu, PH.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wuhan Asia Heart Hospital'}, {'name': 'Zhou xin, Doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Wuhan Asia Heart Hospital'}, {'name': 'liu ze jin, PH.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Wuhan Asia Heart Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wuhan Asia Heart Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}