Ignite Creation Date:
2025-12-24 @ 3:54 PM
Ignite Modification Date:
2026-01-05 @ 6:00 PM
Study NCT ID:
NCT01986192
Status:
UNKNOWN
Last Update Posted:
2014-11-19
First Post:
2013-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069552', 'term': 'Rivaroxaban'}, {'id': 'D014859', 'term': 'Warfarin'}], 'ancestors': [{'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D015110', 'term': '4-Hydroxycoumarins'}, {'id': 'D003374', 'term': 'Coumarins'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-11-18', 'studyFirstSubmitDate': '2013-11-11', 'studyFirstSubmitQcDate': '2013-11-15', 'lastUpdatePostDateStruct': {'date': '2014-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'recurrence rate', 'timeFrame': 'six month', 'description': 'to compare recurrence rate within 6 months after thrombolysis in iliofemoral deep vein thrombosis with warfarin prophylaxis'}], 'secondaryOutcomes': [{'measure': 'vascular events', 'timeFrame': 'six months', 'description': 'All-cause mortality, vascular events (acute coronary syndrome, ischemic stroke, transient ischemic attack or systemic embolism)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['anticoagulation', 'pharmacomechanical thrombolysis', 'aspiration thrombectomy'], 'conditions': ['Ileofemoral Deep Vein Thrombosis']}, 'descriptionModule': {'briefSummary': 'The EINSTEIN program showed that oral rivaroxaban is effective and safe treatment for prevention of recurrent venous thrombosis and pulmonary embolism in deep vein thrombosis patients and FDA approved the rivaroxaban for prevention and treatment of deep vein thrombosis (Nov 2 2012).\n\nRecently, catheter-directed thrombolysis can significantly reduce post-thrombotic syndrome, and more and more centers introduce catheter-directed thrombolysis to treat proximal (i.e, iliofemoral) DVT. However, the EINSTEIN program excluded patients with deep vein thrombosis if they had been treated with a vena cava filter or a fibrinolytic agent for the current episode of thrombosis.\n\nAlthough catheter-directed thrombolysis (CDT) or pharmacomechanical thrombolysis has now been accepted as a treatment of choice in iliofemoral DVT, thrombolysis has an inherent risk of bleeding. Therefore, patients who have completed CDT and have been stabilized at least 24 hours after thrombolysis will be included in this study.\n\nAlso, the investigators want to explore the efficacy and safety of rivaroxaban in patients with iliofemoral DVT after catheter-directed thrombolysis and/or a vena cava filter insertion and/or venous stent insertion and compare these outcomes with warfarin treatment alone.\n\nThis study will be a pilot study to establish the safety and efficacy parameters for further studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 years\n* Onset of symptoms within the past 21 days\n* Objectively verified (by CT venography) deep vein thrombosis localized in the iliofemoral segment\n* Complete catheter-directed thrombolysis and/or a vena cava and/or venous stent insertion\n* Informed consent\n\nExclusion Criteria:\n\n* Incomplete catheter-directed thrombolysis\n* If patients received more than a single dose of a warfarin before randomization\n* contraindicating anticoagulant treatment\n* another indication for a warfarin\n* an estimated glomerular filtration rate by MDRD equation \\<30ml/min\n* clinically significant liver disease (acute hepatitis, chronic active hepatitis, cirrhosis)\n* Alanine aminotransferase \\> 3-time higher than upper limit of the normal range\n* Bacterial endocarditis\n* Active bleeding or high risk of bleeding\n* Pregnancy or breast-feeding\n* Concomitant use of strong cytochrome P-450 3A4 inhibitors or inducers'}, 'identificationModule': {'nctId': 'NCT01986192', 'acronym': 'PRAIS', 'briefTitle': 'Prevention of Recurrence After Thrombolysis in Acute Iliofemoral Venous Thrombosis (PRAIS) Study', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'An Efficacy and Safety Study of Ribaroxaban for the Prevention of Deep Vein Thrombosis Recurrence in Patients With Acute Iliofemoral Venous Thrombosis Initially Treated With Thrombolysis', 'orgStudyIdInfo': {'id': 'PRAIS-1.1-12-12'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'rivaroxaban', 'description': 'Rivaroxaban 15mg bid for 3 weeks and 20mg qd for 6 months', 'interventionNames': ['Drug: rivaroxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'warfarin', 'description': 'Enoxaparin 1mg/kg bid overlapping with warfarin (target PT INR 2.0-3.0) for 6 months', 'interventionNames': ['Drug: Warfarin']}], 'interventions': [{'name': 'rivaroxaban', 'type': 'DRUG', 'otherNames': ['xarelto'], 'armGroupLabels': ['rivaroxaban']}, {'name': 'Warfarin', 'type': 'DRUG', 'armGroupLabels': ['warfarin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Sang-il Min, MD', 'role': 'CONTACT', 'email': 'surgeonmsi@gmail.com', 'phone': '02-2072-2330'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Seung-Kee Min, MD', 'role': 'CONTACT', 'email': 'skminmd@yahoo.com', 'phone': '02-2072-0297'}], 'overallOfficials': [{'name': 'Seung-Kee Min, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Daegu Catholic University Medical Center', 'class': 'OTHER'}, {'name': 'Seoul National University Bundang Hospital', 'class': 'OTHER'}, {'name': 'SMG-SNU Boramae Medical Center', 'class': 'OTHER'}, {'name': 'The Catholic University of Korea', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Seung-Kee Min', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}