Ignite Creation Date:
2025-12-25 @ 3:10 AM
Ignite Modification Date:
2025-12-26 @ 1:49 AM
Study NCT ID:
NCT07246005
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-24
First Post:
2025-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
LVT DURATION: Pilot Study of Anticoagulation Duration for Left Ventricular Thrombus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2025-10-17', 'studyFirstSubmitQcDate': '2025-11-17', 'lastUpdatePostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Stroke and Systemic Embolism (SSE)', 'timeFrame': '6 months', 'description': 'Number of SSE events following randomisation'}, {'measure': 'All-Cause Mortality', 'timeFrame': '6 months', 'description': 'Number of deaths from any cause following randomisation'}], 'secondaryOutcomes': [{'measure': 'Major Bleeding', 'timeFrame': '6 months', 'description': 'Rates of major bleeding (BARC ≥ 3) events following randomisation.'}, {'measure': 'Minor Bleeding', 'timeFrame': '6 months.', 'description': 'Rates of minor bleeding (BARC ≤ 2) events following randomisation.'}, {'measure': 'New LV Thrombi', 'timeFrame': '6 months', 'description': 'Rates of new LV thrombus formation between the groups.'}, {'measure': 'Resolved Thrombus', 'timeFrame': '6 months', 'description': 'Rates of LV thrombus resolution between the groups.'}, {'measure': 'Hospitalisation', 'timeFrame': '6 months', 'description': 'Total number of days in hospital between continuing versus stopping anticoagulation.'}, {'measure': 'Cost Comparison', 'timeFrame': '6 months', 'description': 'Total measured costs between continuing versus stopping anticoagulation.'}, {'measure': 'MI', 'timeFrame': '6 months', 'description': 'Number of participants experiencing MI following randomisation'}, {'measure': 'EQ-5D-5L', 'timeFrame': '6 months', 'description': 'Quality of life of participants measured by EQ-5D-5L.'}, {'measure': 'Perspectives of Clinicians and Patients', 'timeFrame': '6 months', 'description': 'Qualitative assessment of clinician and patient views on study design, procedures, and relevance, collected via structured interviews and surveys'}, {'measure': 'Target Vessel Revascularization (TVR)', 'timeFrame': '6 months', 'description': 'Number of participants undergoing TVR following randomisation'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['LVT', 'Left Ventricular Thrombus', 'Thrombus', 'Thrombi', 'anticoagulant'], 'conditions': ['Left Ventricular Thrombus']}, 'descriptionModule': {'briefSummary': 'The LVT DURATION (Optimal Duration of Anticoagulation for LV Thrombus) is a pilot study planned to assess the practicalities of conducting a randomised control trial (RCT) whilst establishing data around the ideal duration of anticoagulation in the treatment of LV thrombus. The main objectives of the study are:\n\n* To assess the practicalities of conducting an RCT with regard to recruitment, retention, and outcome measurement.\n* To identify the optimal length of anticoagulation in the treatment of LV Thrombus\n\nAfter randomisation participants will:\n\n* Continue their prescribed oral anticoagulant for the remainder of the trial\n* Discontinue their prescribed oral anticoagulant for the remainder of the trial'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of LV thrombus less than 12 months ago\n* On Apixaban at the time of randomisation\n* Completed at least 3 months of anticoagulation treatment for LV thrombus\n* Persistent laminar/ mural thrombus or persistent LV dysfunction\n\nExclusion Criteria:\n\n* Any clinical condition requiring long term anticoagulation treatment as per investigator's judgement.\n* SSE since LV thrombus diagnosis\n* Contraindication to continuing anticoagulation therapy\n* Non-ischaemic Cardiomyopathy\n* Age less than 18 years\n* Unable to consent"}, 'identificationModule': {'nctId': 'NCT07246005', 'acronym': 'LVT Duration', 'briefTitle': 'LVT DURATION: Pilot Study of Anticoagulation Duration for Left Ventricular Thrombus', 'organization': {'class': 'OTHER', 'fullName': 'Queen Mary University of London'}, 'officialTitle': 'A Randomised Pilot Study Assessing the Optimal Duration of Anticoagulation for Left Ventricular Thrombus', 'orgStudyIdInfo': {'id': '1008221'}, 'secondaryIdInfos': [{'id': 'G-002409', 'type': 'OTHER_GRANT', 'domain': 'Barts Charity'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continue pre prescribed rivaroxaban or apixaban or warfarin', 'description': 'If randomised to this arm, participants will continue on their rivaroxaban or apixaban or warfarin for the study related time period.', 'interventionNames': ['Drug: Continue rivaroxaban or apixaban or warfarin']}, {'type': 'EXPERIMENTAL', 'label': 'Discontinue pre prescribed rivaroxaban or apixaban or warfarin', 'description': 'If randomised to this arm, patients (who have already been on OAC for a period of 3 months) will discontinue their rivaroxaban or apixaban or warfarin.', 'interventionNames': ['Drug: Discontinue rivaroxaban or apixaban or warfarin']}], 'interventions': [{'name': 'Continue rivaroxaban or apixaban or warfarin', 'type': 'DRUG', 'description': 'The study is asessing the impact of discontinuation of oral anticoagulation in patients with LV thrombus diagnosis.', 'armGroupLabels': ['Continue pre prescribed rivaroxaban or apixaban or warfarin']}, {'name': 'Discontinue rivaroxaban or apixaban or warfarin', 'type': 'DRUG', 'description': 'discontinue rivaroxaban or apixaban or warfarin', 'armGroupLabels': ['Discontinue pre prescribed rivaroxaban or apixaban or warfarin']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'EC1A4BE', 'city': 'London', 'country': 'United Kingdom', 'contacts': [{'name': 'Mervyn Andiapen', 'role': 'CONTACT', 'email': 'mervyn.andiapen@nhs.net', 'phone': '02037658707'}, {'name': 'Dr Dan Jones', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'St Bartholomews Hospital', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Dr Dan Jones', 'role': 'CONTACT', 'email': 'dan.jones8@nhs.net', 'phone': '02037658707'}, {'name': 'Mervyn Andiapen', 'role': 'CONTACT', 'email': 'mervyn.andiapen@nhs.net', 'phone': '02037658707'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Queen Mary University of London', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}