Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2025-12-25 @ 7:41 PM
Study NCT ID:
NCT03404635
Status:
COMPLETED
Last Update Posted:
2020-08-07
First Post:
2017-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D054556', 'term': 'Venous Thromboembolism'}], 'ancestors': [{'id': 'D013923', 'term': 'Thromboembolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522181', 'term': 'apixaban'}, {'id': 'D000069552', 'term': 'Rivaroxaban'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1300}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-05', 'studyFirstSubmitDate': '2017-12-19', 'studyFirstSubmitQcDate': '2018-01-18', 'lastUpdatePostDateStruct': {'date': '2020-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of re-hospitalization visits for VTE recurrence or bleeding', 'timeFrame': '30 days', 'description': 'Re-hospitalization for \\> 24 hours due to VTE recurrence or bleeding'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Venous Thromboembolism']}, 'referencesModule': {'references': [{'pmid': '34148351', 'type': 'DERIVED', 'citation': "Kline JA, Adler DH, Alanis N, Bledsoe JR, Courtney DM, d'Etienne JP, Diercks DB, Garrett JS, Jones AE, Mackenzie DC, Madsen T, Matuskowitz AJ, Mumma BE, Nordenholz KE, Pagenhardt J, Runyon MS, Stubblefield WB, Willoughby CB. Monotherapy Anticoagulation to Expedite Home Treatment of Patients Diagnosed With Venous Thromboembolism in the Emergency Department: A Pragmatic Effectiveness Trial. Circ Cardiovasc Qual Outcomes. 2021 Jul;14(7):e007600. doi: 10.1161/CIRCOUTCOMES.120.007600. Epub 2021 Jun 21."}]}, 'descriptionModule': {'briefSummary': 'Prospective, multicenter observational study, of the effectiveness of a standard of care protocol implemented to enhance home treatment of VTE. Study population will be selected as part of usual care as eligible for home treatment. Study personnel will travel to participating institutions to qualify the sites, deliver a Powerpoint® lecture to introduce the protocol, meet and train site principal investigators, emergency physicians and research personnel on the implementation of the protocol as part of usual clinical care, and data collection methods for a quality assurance registry with plans to use the data collected in this registry in future publications. Follow-up will be 30 days using medical records and/or telephone interview to assess for primary outcomes of bleeding or VTE recurrence.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Emergency department patients with new or recurrent VTE deemed low-risk by modified Hestia or clinician discretion and sPESI (-).', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients must be low risk, as defined by either A or B below:\n\n A. The modified Hestia criteria:\n * Systolic blood pressure \\> 100 mm Hg\n * No thrombolysis needed\n * No active bleeding\n * SaO2 \\>94% while breathing room air\n * Not already anticoagulated\n * No more than two doses of IV narcotics in the emergency department\n * Other medical or social reasons to admit\n * Creatinine clearance \\>30mL/min\n * Not pregnant, severe liver disease or heparin induced thrombocytopenia OR\n\n B. The physician opinion that a patients' overall social and medical situation is favorable for home treatment and the patient has a zero score on the simplified pulmonary embolism severity index (sPESI).\n\n All of the following must true:\n * Age \\< 81 years\n * No history of cancer\n * No history of heart failure or chronic lung disease\n * Pulse \\< 110 beats/min\n * SBP \\> 99 mm Hg\n * O2 sat \\>89%%\n\n We have chosen either criteria because both have been found equal in terms of safety for outpatient treatment of PE.6,22 Hestia includes implicit questions that most emergency physicians would use as criteria for discharge (e.g., overall medical status and social situation), whereas sPESI does not. For that reason, we have added the additional gestalt assessment question about physician discretion.\n2. Patients must be discharged in \\<24 hours after triage in an ED visit with diagnosis of VTE using objective criteria in the emergency department.\n\nExclusion Criteria:\n\n* VTE diagnosis while taking anticoagulants with evidence of compliance (e.g., physician opinion that patient is taking a Eliquis®, Xarelto® or Pradaxa®, low molecular weight heparin injections or warfarin as prescribed for any condition)\n* Sensitivity or contraindication to use of apixaban\n* Troponin assay value, drawn as part of usual care and found to be positive, using local standards\n* High risk for hemorrhage defined by a score\\>1.5 using the method of Ruiz Gimenez.3 (Note that several criteria are already excluded by Hestia):\n\nRecent major bleeding, 2 points Creatinine levels \\>1.2 mg/dl, 1.5 points Anemia, 1.5 points Cancer, 1 point Clinically overt PE, 1 point Age \\>75 years, 1 point"}, 'identificationModule': {'nctId': 'NCT03404635', 'acronym': 'MATHVTE', 'briefTitle': 'Monotherapy Anticoagulation To Expedite Home Treatment of Venous Thromboembolism', 'organization': {'class': 'OTHER', 'fullName': 'Indiana University'}, 'officialTitle': 'Monotherapy Anticoagulation To Expedite Home Treatment of Venous', 'orgStudyIdInfo': {'id': 'CV185-562'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Apixaban for VTE', 'interventionNames': ['Drug: Apixaban']}, {'label': 'Rivaroxaban for VTE', 'interventionNames': ['Drug: Rivaroxaban']}], 'interventions': [{'name': 'Apixaban', 'type': 'DRUG', 'description': 'Apixaban as standard of care for VTE', 'armGroupLabels': ['Apixaban for VTE']}, {'name': 'Rivaroxaban', 'type': 'DRUG', 'description': 'Rivaroxaban as standard of care for VTE', 'armGroupLabels': ['Rivaroxaban for VTE']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Eskenazi Health System', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Health Methodist Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indiana University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, {'name': 'Pfizer', 'class': 'INDUSTRY'}, {'name': 'Janssen Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Emergency Medicine', 'investigatorFullName': 'Jeffrey Kline', 'investigatorAffiliation': 'Indiana University'}}}}