Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 8:47 AM
Study NCT ID:
NCT07388056
Status:
COMPLETED
Last Update Posted:
2026-02-04
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Extended Anticoagulant Therapy in Cancer Associated Thrombosis in Thai Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000925', 'term': 'Anticoagulants'}], 'ancestors': [{'id': 'D006401', 'term': 'Hematologic Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-30', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent thrombosis', 'timeFrame': 'After completing 6-month of treatment to the time that anticoagulant stop or recurrent thrombosis occurred through study completion, at the end of December 2025.', 'description': 'cumulative incidence of recurrent thrombosis'}], 'secondaryOutcomes': [{'measure': 'Anticoagulant related bleeding', 'timeFrame': 'After completing 6-month of treatment to the time that anticoagulant stop or bleeding occurred through study completion, at the end of December 2025.', 'description': 'cumulative incidence of bleeding'}, {'measure': 'Overall survival', 'timeFrame': 'The time from VTE diagnosis to last follow up or die through study completion, at the end of December 2025.', 'description': 'Overall survival'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'conditions': ['Cancer-associated Thrombosis']}, 'descriptionModule': {'briefSummary': "The goal of this observational study is to learn about the long-term efficacy and safety of extended anticoagulant treatment in patients with cancer associated thrombosis. (CAT) The main question it aims to answer is:\n\n• Does extended prophylactic dose anticoagulant provide comparable efficacy and safety to therapeutic dosing after 6-month treatment of anticoagulant? The medical record data of participants who's already received for at least 6-month anticoagulant treatment upon regular medical care for CAT will be collected and analyzed about their recurrent thrombosis, anticoagulant related bleeding, and survival outcome.", 'detailedDescription': 'Adult patients aged ≥18 years with histopathological confirmed cancer, treated at Thammasat University Hospital and Panyananthaphikkhu Chonprathan Medical Center between January 2012 and December 2022, were eligible for inclusion.\n\nPatients were initially screened using ICD-10 diagnostic codes C00-D009 for malignancy in conjunction with codes for venous thromboembolism (I82.-, other venous embolism and thrombosis; K55.0, mesenteric vein thrombosis; I82.0, hepatic vein thrombosis; K75.1, phlebitis of the portal vein; and I26.-, pulmonary embolism). Eligible patients required to have a radiologically confirmed diagnosis of cancer-associated thrombosis (CAT) and to have received anticoagulation therapy for at least six months. Clinical data were extracted from the Computerized Provider Order Entry (CPOE) system.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated at Thammasat University Hospital or Panyananthaphikkhu Chonprathan Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': "Here's a polished version of your Inclusion and Exclusion Criteria section with grammar, spelling, and phrasing corrected for clarity and formal research style:\n\nInclusion Criteria\n\n* Adult patients aged ≥18 years\n* Histopathologically confirmed cancer\n* Radiologically confirmed diagnosis of cancer-associated thrombosis (CAT)\n* Received anticoagulation therapy for at least six months Exclusion Criteria\n* Patients who do not meet the inclusion criteria"}, 'identificationModule': {'nctId': 'NCT07388056', 'briefTitle': 'Efficacy and Safety of Extended Anticoagulant Therapy in Cancer Associated Thrombosis in Thai Population', 'organization': {'class': 'OTHER', 'fullName': 'Thammasat University'}, 'officialTitle': 'Efficacy and Safety of Extended Anticoagulant Therapy in Cancer Associated Thrombosis-A Ten Year Retrospective Study.', 'orgStudyIdInfo': {'id': 'MTU-EC-IM-1-301/65'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Therapeutic dose anticoagulant group', 'description': 'including patients with the standard therapeutic dose-administered after the initial six-month treatment period.', 'interventionNames': ['Drug: Anticoagulant']}, {'label': 'Prophylactic dose anticoagulant group', 'description': 'including patients with the doses lower than therapeutic dose-administered at any point after the initial six-month treatment period.', 'interventionNames': ['Drug: Anticoagulant']}], 'interventions': [{'name': 'Anticoagulant', 'type': 'DRUG', 'description': 'warfarin at therapeutic level (INR 2-3), Low molecular weight heparin (LMWH) DOAC', 'armGroupLabels': ['Prophylactic dose anticoagulant group', 'Therapeutic dose anticoagulant group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thammasat University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Hematology, Internal medicine, Faculty of medicine', 'investigatorFullName': 'Lantarima Bhoopat', 'investigatorAffiliation': 'Thammasat University'}}}}