Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2026-02-26 @ 11:01 AM
Study NCT ID:
NCT01573169
Status:
TERMINATED
Last Update Posted:
2021-09-10
First Post:
2012-03-31
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083302', 'term': 'Hemorrhagic Stroke'}, {'id': 'D054556', 'term': 'Venous Thromboembolism'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017984', 'term': 'Enoxaparin'}], 'ancestors': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'maurizio.paciaroni@unipg.it', 'phone': '+390755786424', 'title': 'Dr. Maurizio Paciaroni', 'organization': 'Stroke Unit and Division of Internal and Cardiovascular Medicine University of Perugia, Santa Maria della Misericordia Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Low Weight Molecular Heparin', 'description': 'enoxaparin 0.4 ml subcutaneous per day\n\nEnoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 0, 'seriousNumAtRisk': 38, 'deathsNumAffected': 7, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Standard Therapy', 'description': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization\n\nGraduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 0, 'seriousNumAtRisk': 35, 'deathsNumAffected': 6, 'seriousNumAffected': 3}], 'seriousEvents': [{'term': 'extracranial bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intracranial bleedings', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Weight Molecular Heparin', 'description': 'enoxaparin 0.4 ml subcutaneous per day\n\nEnoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization\n\nGraduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '10 days', 'description': 'Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bleedings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Weight Molecular Heparin', 'description': 'enoxaparin 0.4 ml subcutaneous per day\n\nEnoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization\n\nGraduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'symptomatic and asymptomatic intra and extracranial bleedings', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Weight Molecular Heparin', 'description': 'enoxaparin 0.4 ml subcutaneous per day\n\nEnoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization\n\nGraduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'mortality of any cause', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Disability', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Weight Molecular Heparin', 'description': 'enoxaparin 0.4 ml subcutaneous per day\n\nEnoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke'}, {'id': 'OG001', 'title': 'Standard Therapy', 'description': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization\n\nGraduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '90 days', 'description': 'modified Rankin Scale (mRS) equal to and greater than 3.\n\n0 - No symptoms.\n\n1. \\- No significant disability. Able to carry out all usual activities, despite some symptoms.\n2. \\- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n3. \\- Moderate disability. Requires some help, but able to walk unassisted.\n4. \\- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n5. \\- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\n6. \\- Dead.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Weight Molecular Heparin', 'description': 'enoxaparin 0.4 ml subcutaneous per day\n\nEnoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke'}, {'id': 'FG001', 'title': 'Standard Therapy', 'description': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization\n\nGraduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No wash-out, nor run-in events.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Weight Molecular Heparin', 'description': 'enoxaparin 0.4 ml subcutaneous per day\n\nEnoxaparin: enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke'}, {'id': 'BG001', 'title': 'Standard Therapy', 'description': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization\n\nGraduated compression stockings and/or intermittent pneumatic compression and/or early mobilization: placebo standard therapy'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.4', 'spread': '13.7', 'groupId': 'BG000'}, {'value': '71.5', 'spread': '11.6', 'groupId': 'BG001'}, {'value': '70.9', 'spread': '12.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Obesity', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2011-06-01', 'size': 155337, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-09-09T06:39', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'whyStopped': 'The trial has been terminated prematurely after the randomization of 73 patients due to a lack of funding.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-09', 'studyFirstSubmitDate': '2012-03-31', 'resultsFirstSubmitDate': '2021-01-03', 'studyFirstSubmitQcDate': '2012-04-04', 'lastUpdatePostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-09-09', 'studyFirstPostDateStruct': {'date': '2012-04-06', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Symptomatic and Asymptomatic Venous Thromboembolism', 'timeFrame': '10 days', 'description': 'Symptomatic venous thromboembolism (deep venous thrombosis and/or pulmonary embolism) and asymptomatic deep venous thrombosis on ultrasound examination'}], 'secondaryOutcomes': [{'measure': 'Bleedings', 'timeFrame': '90 days', 'description': 'symptomatic and asymptomatic intra and extracranial bleedings'}, {'measure': 'Mortality', 'timeFrame': '90 days', 'description': 'mortality of any cause'}, {'measure': 'Disability', 'timeFrame': '90 days', 'description': 'modified Rankin Scale (mRS) equal to and greater than 3.\n\n0 - No symptoms.\n\n1. \\- No significant disability. Able to carry out all usual activities, despite some symptoms.\n2. \\- Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.\n3. \\- Moderate disability. Requires some help, but able to walk unassisted.\n4. \\- Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.\n5. \\- Severe disability. Requires constant nursing care and attention, bedridden, incontinent.\n6. \\- Dead.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['hemorrhagic stroke', 'venous thromboembolism', 'prevention'], 'conditions': ['Hemorrhagic Stroke', 'Venous Thromboembolism', 'Deep Venous Thrombosis']}, 'referencesModule': {'references': [{'pmid': '21324058', 'type': 'BACKGROUND', 'citation': 'Paciaroni M, Agnelli G, Venti M, Alberti A, Acciarresi M, Caso V. Efficacy and safety of anticoagulants in the prevention of venous thromboembolism in patients with acute cerebral hemorrhage: a meta-analysis of controlled studies. J Thromb Haemost. 2011 May;9(5):893-8. doi: 10.1111/j.1538-7836.2011.04241.x.'}, {'pmid': '36700520', 'type': 'DERIVED', 'citation': 'Cochrane A, Chen C, Stephen J, Ronning OM, Anderson CS, Hankey GJ, Al-Shahi Salman R. Antithrombotic treatment after stroke due to intracerebral haemorrhage. Cochrane Database Syst Rev. 2023 Jan 26;1(1):CD012144. doi: 10.1002/14651858.CD012144.pub3.'}, {'pmid': '33190135', 'type': 'DERIVED', 'citation': "Paciaroni M, Agnelli G, Alberti A, Becattini C, Guercini F, Martini G, Tassi R, Marotta G, Venti M, Acciarresi M, Mosconi MG, Marcheselli S, Fratticci L, D'Amore C, Ageno W, Versino M, De Lodovici ML, Carimati F, Pezzini A, Padovani A, Corea F, Scoditti U, Denti L, Tassinari T, Silvestrelli G, Ciccone A, Caso V. PREvention of VENous Thromboembolism in Hemorrhagic Stroke Patients - PREVENTIHS Study: A Randomized Controlled Trial and a Systematic Review and Meta-Analysis. Eur Neurol. 2020;83(6):566-575. doi: 10.1159/000511574. Epub 2020 Nov 13."}]}, 'descriptionModule': {'briefSummary': 'Patients with cerebral hemorrhage (ICH) have a high risk of venous thromboembolism. Intermittent pneumatic compression combined with elastic stockings have been shown to be superior to elastic stockings alone in reducing the rate of asymptomatic deep vein thrombosis after ICH in a randomized trial (4.7% vs. 15.9%). Graduated compression stockings alone are ineffective in preventing deep vein thrombosis in patients with ischemic or hemorrhagic stroke. Less clear is the role of anticoagulation in the prevention of venous thromboembolism in patients with ICH because the use of anticoagulants may cause an enlargement of the hematoma. In a multicenter, randomized trial, the investigators will assess the efficacy and safety of enoxaparin in the prevention of venous thromboembolism in patients with spontaneous intracerebral hemorrhage. Enoxaparin (40 mg once daily) or standard therapy (graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization) will be given subcutaneously for not less than 10 days beginning after 72 hours from stroke onset.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Intracranial spontaneous hemorrhage on brain CT scan\n* Intracranial hemorrhage during treatment with oral anticoagulants\n* Bedridden patients (item 6 of NIHSS: motor leg points 3 or 4 or severe ataxia for cerebellar hemorrhage).\n\nExclusion Criteria:\n\n* cerebral hemorrhage due to intracranial vascular malformation\n* rebleeding on CT scan after 72 hours from stroke (before randomization)'}, 'identificationModule': {'nctId': 'NCT01573169', 'acronym': 'PREVENTIHS', 'briefTitle': 'PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients', 'organization': {'class': 'OTHER', 'fullName': 'University Of Perugia'}, 'officialTitle': 'PREvention of VENous Thromboembolism In Hemorrhagic Stroke Patients', 'orgStudyIdInfo': {'id': 'PREVENTIHS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low weight molecular heparin', 'description': 'enoxaparin 0.4 ml subcutaneous per day', 'interventionNames': ['Drug: Enoxaparin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'standard therapy', 'description': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization', 'interventionNames': ['Other: Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization']}], 'interventions': [{'name': 'Enoxaparin', 'type': 'DRUG', 'description': 'enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke', 'armGroupLabels': ['low weight molecular heparin']}, {'name': 'Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization', 'type': 'OTHER', 'description': 'placebo standard therapy', 'armGroupLabels': ['standard therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06126', 'city': 'Perugia', 'country': 'Italy', 'facility': 'Stroke Unit', 'geoPoint': {'lat': 43.1122, 'lon': 12.38878}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Of Perugia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maurizio Paciaroni', 'investigatorAffiliation': 'University Of Perugia'}}}}