Ignite Creation Date:
2025-12-25 @ 12:22 AM
Ignite Modification Date:
2026-01-01 @ 8:55 PM
Study NCT ID:
NCT04142658
Status:
TERMINATED
Last Update Posted:
2024-03-20
First Post:
2019-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}]}, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'melissa.thalin@artivion.com', 'phone': '770-419-3355', 'title': 'Melissa Thalin, Director, New Indications', 'organization': 'Artivion'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'through study closure, a median follow-up of 13.5 months', 'description': 'Events collected and reported were valve thrombosis or dysfunction, stroke or TIA, myocardial infarction, arterial thromboembolism, bleeding, hospitalization and the reason for hospitalization, death and the cause of death.', 'eventGroups': [{'id': 'EG000', 'title': 'Apixaban', 'description': 'Apixaban 5 mg twice daily(BID) or 2.5 mg BID\n\nApixaban 5 MG: For patients that do NOT meet the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nApixaban 2.5 MG: For patients that meet at least 2 of the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.', 'otherNumAtRisk': 433, 'deathsNumAtRisk': 433, 'otherNumAffected': 16, 'seriousNumAtRisk': 433, 'deathsNumAffected': 2, 'seriousNumAffected': 11}, {'id': 'EG001', 'title': 'Warfarin', 'description': 'Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)\n\nWarfarin: Active Control Intervention\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.', 'otherNumAtRisk': 430, 'deathsNumAtRisk': 430, 'otherNumAffected': 6, 'seriousNumAtRisk': 430, 'deathsNumAffected': 1, 'seriousNumAffected': 18}], 'otherEvents': [{'term': 'Valve thrombosis or Valve-related thromboembolism', 'notes': 'thrombus, thromboembolic stroke, thromboembolic transient ischemic attack (TIA), thromboembolic myocardial infarction, or arterial thromboembolism to another organ or limb', 'stats': [{'groupId': 'EG000', 'numAtRisk': 433, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Major Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 433, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 430, 'numEvents': 21, 'numAffected': 18}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CDRH'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Composite of Valve Thrombosis and Valve-related Thromboembolism', 'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'OG000'}, {'value': '430', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Apixaban 5 mg twice daily(BID) or 2.5 mg BID\n\nApixaban 5 MG: For patients that do NOT meet the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nApixaban 2.5 MG: For patients that meet at least 2 of the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)\n\nWarfarin: Active Control Intervention\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.'}], 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study closure, a median follow-up of 13.5 months', 'description': 'Valve thrombosis was defined as any thrombus, not caused by infection, attached to or near an implanted On-X valve that occluded part of the blood-flow path, interfered with valve function, or was sufficiently large to warrant treatment other than continued oral anticoagulation. Valve-related thromboembolism was defined as any thromboembolic stroke, transient ischemic attack, myocardial infarction, or arterial thromboembolism to an organ or limb that was not associated with infection or an intracardiac tumor and was definitely or possibly related to the valve.', 'unitOfMeasure': 'events per patient-years', 'reportingStatus': 'POSTED', 'populationDescription': 'Patient years is determined by the number of events in the Intention to Treat group (all randomized participants) divided by the amount of person-time at risk.'}, {'type': 'PRIMARY', 'title': 'Major Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '420', 'groupId': 'OG000'}, {'value': '414', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Apixaban', 'description': 'Apixaban 5 mg twice daily(BID) or 2.5 mg BID\n\nApixaban 5 MG: For patients that do NOT meet the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nApixaban 2.5 MG: For patients that meet at least 2 of the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.'}, {'id': 'OG001', 'title': 'Warfarin', 'description': 'Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)\n\nWarfarin: Active Control Intervention\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'through study closure, a median follow-up of 13.5 months', 'description': 'Major bleeding defined as any episode of internal or external bleeding that caused death, hospitalization, or permanent injury or necessitated transfusion, pericardiocentesis, or reoperation.', 'unitOfMeasure': 'event', 'reportingStatus': 'POSTED', 'populationDescription': 'On treatment group'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Apixaban', 'description': 'Apixaban 5 mg twice daily(BID) or 2.5 mg BID\n\nApixaban 5 MG: For patients that do NOT meet the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nApixaban 2.5 MG: For patients that meet at least 2 of the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.'}, {'id': 'FG001', 'title': 'Warfarin', 'description': 'Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)\n\nWarfarin: Active Control Intervention\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '433'}, {'groupId': 'FG001', 'numSubjects': '430'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '400'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '30'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '16'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '433', 'groupId': 'BG000'}, {'value': '430', 'groupId': 'BG001'}, {'value': '863', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Apixaban', 'description': 'Apixaban 5 mg twice daily(BID) or 2.5 mg BID\n\nApixaban 5 MG: For patients that do NOT meet the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nApixaban 2.5 MG: For patients that meet at least 2 of the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.'}, {'id': 'BG001', 'title': 'Warfarin', 'description': 'Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)\n\nWarfarin: Active Control Intervention\n\nOn-X Aortic Mechanical Valve: Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000', 'lowerLimit': '47', 'upperLimit': '63'}, {'value': '55', 'groupId': 'BG001', 'lowerLimit': '47', 'upperLimit': '63'}, {'value': '56', 'groupId': 'BG002', 'lowerLimit': '47', 'upperLimit': '63'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '105', 'groupId': 'BG001'}, {'value': '207', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '331', 'groupId': 'BG000'}, {'value': '325', 'groupId': 'BG001'}, {'value': '656', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '400', 'groupId': 'BG000'}, {'value': '406', 'groupId': 'BG001'}, {'value': '806', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '390', 'groupId': 'BG001'}, {'value': '785', 'groupId': 'BG002'}]}]}, {'title': 'Multiracial', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '29.9', 'groupId': 'BG000', 'lowerLimit': '26.3', 'upperLimit': '34.3'}, {'value': '30.1', 'groupId': 'BG001', 'lowerLimit': '26.3', 'upperLimit': '35.0'}, {'value': '29.9', 'groupId': 'BG002', 'lowerLimit': '26.3', 'upperLimit': '34.6'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-11', 'size': 1669201, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-07-20T15:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel control and treatment arm at a 1:1 ratio.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 863}}, 'statusModule': {'whyStopped': 'Safety', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2019-10-09', 'resultsFirstSubmitDate': '2023-07-20', 'studyFirstSubmitQcDate': '2019-10-25', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-18', 'studyFirstPostDateStruct': {'date': '2019-10-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite of Valve Thrombosis and Valve-related Thromboembolism', 'timeFrame': 'through study closure, a median follow-up of 13.5 months', 'description': 'Valve thrombosis was defined as any thrombus, not caused by infection, attached to or near an implanted On-X valve that occluded part of the blood-flow path, interfered with valve function, or was sufficiently large to warrant treatment other than continued oral anticoagulation. Valve-related thromboembolism was defined as any thromboembolic stroke, transient ischemic attack, myocardial infarction, or arterial thromboembolism to an organ or limb that was not associated with infection or an intracardiac tumor and was definitely or possibly related to the valve.'}, {'measure': 'Major Bleeding', 'timeFrame': 'through study closure, a median follow-up of 13.5 months', 'description': 'Major bleeding defined as any episode of internal or external bleeding that caused death, hospitalization, or permanent injury or necessitated transfusion, pericardiocentesis, or reoperation.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Aortic Valve Disease', 'Aortic Valve Stenosis', 'Aortic Valve Failure']}, 'referencesModule': {'references': [{'pmid': '18374749', 'type': 'BACKGROUND', 'citation': 'Akins CW, Miller DC, Turina MI, Kouchoukos NT, Blackstone EH, Grunkemeier GL, Takkenberg JJ, David TE, Butchart EG, Adams DH, Shahian DM, Hagl S, Mayer JE, Lytle BW; Councils of the American Association for Thoracic Surgery; Society of Thoracic Surgeons; European Assoication for Cardio-Thoracic Surgery; Ad Hoc Liaison Committee for Standardizing Definitions of Prosthetic Heart Valve Morbidity. Guidelines for reporting mortality and morbidity after cardiac valve interventions. J Thorac Cardiovasc Surg. 2008 Apr;135(4):732-8. doi: 10.1016/j.jtcvs.2007.12.002. No abstract available.'}, {'pmid': '26530269', 'type': 'BACKGROUND', 'citation': 'Bourguignon T, Lhommet P, El Khoury R, Candolfi P, Loardi C, Mirza A, Boulanger-Lothion J, Bouquiaux-Stablo-Duncan AL, Marchand M, Aupart M. Very long-term outcomes of the Carpentier-Edwards Perimount aortic valve in patients aged 50-65 years. Eur J Cardiothorac Surg. 2016 May;49(5):1462-8. doi: 10.1093/ejcts/ezv384. Epub 2015 Nov 2.'}, {'pmid': '22341654', 'type': 'BACKGROUND', 'citation': 'Chambers JB, Pomar JL, Mestres CA, Palatianos GM. Clinical event rates with the On-X bileaflet mechanical heart valve: a multicenter experience with follow-up to 12 years. J Thorac Cardiovasc Surg. 2013 Feb;145(2):420-4. doi: 10.1016/j.jtcvs.2011.12.059. Epub 2012 Feb 17.'}, {'pmid': '23991661', 'type': 'BACKGROUND', 'citation': 'Eikelboom JW, Connolly SJ, Brueckmann M, Granger CB, Kappetein AP, Mack MJ, Blatchford J, Devenny K, Friedman J, Guiver K, Harper R, Khder Y, Lobmeyer MT, Maas H, Voigt JU, Simoons ML, Van de Werf F; RE-ALIGN Investigators. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. doi: 10.1056/NEJMoa1300615. Epub 2013 Aug 31.'}, {'pmid': '26559386', 'type': 'BACKGROUND', 'citation': 'Glaser N, Jackson V, Holzmann MJ, Franco-Cereceda A, Sartipy U. Aortic valve replacement with mechanical vs. biological prostheses in patients aged 50-69 years. Eur Heart J. 2016 Sep 7;37(34):2658-67. doi: 10.1093/eurheartj/ehv580. Epub 2015 Nov 11.'}, {'pmid': '29117490', 'type': 'BACKGROUND', 'citation': 'Goldstone AB, Chiu P, Baiocchi M, Lingala B, Patrick WL, Fischbein MP, Woo YJ. Mechanical or Biologic Prostheses for Aortic-Valve and Mitral-Valve Replacement. N Engl J Med. 2017 Nov 9;377(19):1847-1857. doi: 10.1056/NEJMoa1613792.'}, {'pmid': '21870978', 'type': 'BACKGROUND', 'citation': 'Granger CB, Alexander JH, McMurray JJ, Lopes RD, Hylek EM, Hanna M, Al-Khalidi HR, Ansell J, Atar D, Avezum A, Bahit MC, Diaz R, Easton JD, Ezekowitz JA, Flaker G, Garcia D, Geraldes M, Gersh BJ, Golitsyn S, Goto S, Hermosillo AG, Hohnloser SH, Horowitz J, Mohan P, Jansky P, Lewis BS, Lopez-Sendon JL, Pais P, Parkhomenko A, Verheugt FW, Zhu J, Wallentin L; ARISTOTLE Committees and Investigators. Apixaban versus warfarin in patients with atrial fibrillation. N Engl J Med. 2011 Sep 15;365(11):981-92. doi: 10.1056/NEJMoa1107039. Epub 2011 Aug 27.'}, {'pmid': '27217434', 'type': 'BACKGROUND', 'citation': 'Head SJ, Mylotte D, Mack MJ, Piazza N, van Mieghem NM, Leon MB, Kappetein AP, Holmes DR Jr. Considerations and Recommendations for the Introduction of Objective Performance Criteria for Transcatheter Aortic Heart Valve Device Approval. Circulation. 2016 May 24;133(21):2086-93. doi: 10.1161/CIRCULATIONAHA.115.020493.'}, {'pmid': '28444168', 'type': 'BACKGROUND', 'citation': 'Head SJ, Celik M, Kappetein AP. Mechanical versus bioprosthetic aortic valve replacement. Eur Heart J. 2017 Jul 21;38(28):2183-2191. doi: 10.1093/eurheartj/ehx141.'}, {'pmid': '24548571', 'type': 'BACKGROUND', 'citation': 'IntHout J, Ioannidis JP, Borm GF. The Hartung-Knapp-Sidik-Jonkman method for random effects meta-analysis is straightforward and considerably outperforms the standard DerSimonian-Laird method. BMC Med Res Methodol. 2014 Feb 18;14:25. doi: 10.1186/1471-2288-14-25.'}, {'pmid': '15132746', 'type': 'BACKGROUND', 'citation': 'Samsa G, Matchar DB, Dolor RJ, Wiklund I, Hedner E, Wygant G, Hauch O, Marple CB, Edwards R. A new instrument for measuring anticoagulation-related quality of life: development and preliminary validation. Health Qual Life Outcomes. 2004 May 6;2:22. doi: 10.1186/1477-7525-2-22.'}, {'pmid': '28232327', 'type': 'BACKGROUND', 'citation': 'Lester PA, Coleman DM, Diaz JA, Jackson TO, Hawley AE, Mathues AR, Grant BT, Knabb RM, Ramacciotti E, Frost CE, Song Y, Wakefield TW, Myers DD Jr. Apixaban Versus Warfarin for Mechanical Heart Valve Thromboprophylaxis in a Swine Aortic Heterotopic Valve Model. Arterioscler Thromb Vasc Biol. 2017 May;37(5):942-948. doi: 10.1161/ATVBAHA.116.308649. Epub 2017 Feb 23.'}, {'pmid': '16480015', 'type': 'BACKGROUND', 'citation': 'McNicholas KW, Ivey TD, Metras J, Szentpetery S, Marra SW, Masters RG, Dilling EW, Slaughter MS, Mack MJ. North American multicenter experience with the On-X prosthetic heart valve. J Heart Valve Dis. 2006 Jan;15(1):73-8; discussion 79.'}, {'pmid': '17184628', 'type': 'BACKGROUND', 'citation': 'Palatianos GM, Laczkovics AM, Simon P, Pomar JL, Birnbaum DE, Greve HH, Haverich A. Multicentered European study on safety and effectiveness of the On-X prosthetic heart valve: intermediate follow-up. Ann Thorac Surg. 2007 Jan;83(1):40-6. doi: 10.1016/j.athoracsur.2006.08.010.'}, {'pmid': '24512654', 'type': 'BACKGROUND', 'citation': 'Puskas J, Gerdisch M, Nichols D, Quinn R, Anderson C, Rhenman B, Fermin L, McGrath M, Kong B, Hughes C, Sethi G, Wait M, Martin T, Graeve A; PROACT Investigators. Reduced anticoagulation after mechanical aortic valve replacement: interim results from the prospective randomized on-X valve anticoagulation clinical trial randomized Food and Drug Administration investigational device exemption trial. J Thorac Cardiovasc Surg. 2014 Apr;147(4):1202-1210; discussion 1210-1. doi: 10.1016/j.jtcvs.2014.01.004. Epub 2014 Jan 12.'}, {'pmid': '29903344', 'type': 'BACKGROUND', 'citation': 'Puskas JD, Gerdisch M, Nichols D, Fermin L, Rhenman B, Kapoor D, Copeland J, Quinn R, Hughes GC, Azar H, McGrath M, Wait M, Kong B, Martin T, Douville EC, Meyer S, Ye J, Jamieson WRE, Landvater L, Hagberg R, Trotter T, Armitage J, Askew J, Accola K, Levy P, Duncan D, Yanagawa B, Ely J, Graeve A; PROACT Investigators. Anticoagulation and Antiplatelet Strategies After On-X Mechanical Aortic Valve Replacement. J Am Coll Cardiol. 2018 Jun 19;71(24):2717-2726. doi: 10.1016/j.jacc.2018.03.535.'}, {'pmid': '17944128', 'type': 'BACKGROUND', 'citation': 'Tossios P, Reber D, Oustria M, Holland-Letz T, Germing A, Buchwald D, Laczkovics A. Single-center experience with the On-X prosthetic heart valve between 1996 and 2005. J Heart Valve Dis. 2007 Sep;16(5):551-7.'}, {'pmid': '16480016', 'type': 'BACKGROUND', 'citation': 'Williams MA, van Riet S. The On-X heart valve: mid-term results in a poorly anticoagulated population. J Heart Valve Dis. 2006 Jan;15(1):80-6.'}, {'pmid': '25258160', 'type': 'BACKGROUND', 'citation': 'Wu Y, Butchart EG, Borer JS, Yoganathan A, Grunkemeier GL. Clinical evaluation of new heart valve prostheses: update of objective performance criteria. Ann Thorac Surg. 2014 Nov;98(5):1865-74. doi: 10.1016/j.athoracsur.2014.05.006. Epub 2014 Sep 23.'}, {'pmid': '32693197', 'type': 'BACKGROUND', 'citation': 'Jawitz OK, Wang TY, Lopes RD, Chavez A, Boyer B, Kim H, Anstrom KJ, Becker RC, Blackstone E, Ruel M, Thourani VH, Puskas JD, Gerdisch MW, Johnston D, Capps S, Alexander JH, Svensson LG. Rationale and design of PROACT Xa: A randomized, multicenter, open-label, clinical trial to evaluate the efficacy and safety of apixaban versus warfarin in patients with a mechanical On-X Aortic Heart Valve. Am Heart J. 2020 Sep;227:91-99. doi: 10.1016/j.ahj.2020.06.014. Epub 2020 Jun 25.'}, {'pmid': '38320162', 'type': 'DERIVED', 'citation': 'Wang TY, Svensson LG, Wen J, Vekstein A, Gerdisch M, Rao VU, Moront M, Johnston D, Lopes RD, Chavez A, Ruel M, Blackstone EH, Becker RC, Thourani V, Puskas J, Al-Khalidi HR, Cable DG, Elefteriades JA, Pochettino A, Wolfe JA, Graeve A, Sultan I, Sabe AA, Michelena HI, Alexander JH. Apixaban or Warfarin in Patients with an On-X Mechanical Aortic Valve. NEJM Evid. 2023 Jul;2(7):EVIDoa2300067. doi: 10.1056/EVIDoa2300067. Epub 2023 May 6.'}]}, 'descriptionModule': {'briefSummary': 'Currently, warfarin is the only approved anticoagulation for patients with mechanical valves. The purpose of this study is to determine if participants with an On-X Prosthetic Heart Valve / On-X aortic valve can be maintained safely and effectively on apixaban. Both the On-X aortic valve and apixaban have been approved for use by the US Food and Drug Administration (FDA) but they have not been approved to be used together.', 'detailedDescription': 'There is an unmet clinical need for an alternative to warfarin, such as a direct oral anticoagulant (DOAC), as anticoagulation in participants with an aortic mechanical prosthetic valve. Some participants may be genetically hyper- or hypo-responsive to warfarin, which makes management difficult. Another small group of participants is allergic to warfarin. A much larger group of participants has difficulty maintaining warfarin control due to dietary and drug interactions. Finally, the requirement for routine blood testing makes people reluctant to take warfarin. All of these factors drive younger participants in need of aortic valve replacement (AVR) toward selection of a tissue valve instead of a mechanical valve. Despite multiple studies (randomized, matched and risk adjusted) that show that tissue valves are associated with worse outcomes, younger participants choose this type of valve to avoid warfarin. In addition, multiple clinical studies have shown valve reoperation rates are higher for tissue valves used in these younger participants. Providing an alternative to warfarin anticoagulation may lead younger participants to choose a mechanical valve with greater durability and better clinical outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female at least 18 years of age at the time of giving informed consent.\n* Participants currently receiving warfarin anticoagulation and who are able to receive warfarin with a target INR 2.0 to 3.0.\n* Participants are able to take low-dose aspirin at a dose of 75 -100 mg daily or have a documented contraindication to aspirin use.\n* Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.\n* Female participants of childbearing potential, including those who are less than 2 years post-menopausal, must agree to, and comply with using a highly effective method of birth control (eg, barrier contraceptives \\[condom or diaphragm with a spermicidal gel\\], hormonal contraceptives \\[implants, injectables, combination oral contraceptives, transdermal patches, or contraceptive rings\\], intrauterine devices or sexual abstinence) while partaking in this study. In addition, all women of childbearing potential must agree to continue to use birth control throughout the study until last study visit.\n* Informed of the full nature and purpose of the study, including possible risks and side effects, given ample time and opportunity to read and understand this information, and sign and date the written informed consent before inclusion in the study.\n\nExclusion Criteria:\n\n* Mechanical valve in any position other than aortic valve.\n* Any cardiac surgery in the three months (90 days) prior to enrollment.\n* Need to be on aspirin \\>100 mg daily or a P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel, or ticlopidine).\n* Known hypersensitivity or other contraindication to apixaban.\n* On dialysis or a creatinine clearance \\< 25 mL/min.\n* Ischemic stroke or intracranial hemorrhage within 3 months.\n* Active pathological bleeding at the time of screening for enrollment.\n* Active endocarditis at the time of screening for enrollment.\n* Pregnant, plan to become pregnant, or are breast feeding.\n* On concomitant combined strong P-gp and CYP3A4 inducers or inhibitors.\n* History of non-compliance with recommended monthly INR testing.'}, 'identificationModule': {'nctId': 'NCT04142658', 'briefTitle': 'PROACT Xa - A Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely on Apixaban', 'organization': {'class': 'INDUSTRY', 'fullName': 'Artivion Inc.'}, 'officialTitle': 'A Prospective, Randomized, Active (Warfarin) Controlled, Parallel-arm Clinical Trial to Determine if Participants With an On-X Aortic Valve Can be Maintained Safely and Effectively on Apixaban', 'orgStudyIdInfo': {'id': 'ONX1801.000-C'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apixaban', 'description': 'Apixaban 5 mg twice daily(BID) or 2.5 mg BID', 'interventionNames': ['Drug: Apixaban 5 MG', 'Drug: Apixaban 2.5 MG', 'Device: On-X Aortic Mechanical Valve']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Warfarin', 'description': 'Patients randomized to the warfarin arm will continue warfarin in the INR range of (2.0-3.0)', 'interventionNames': ['Drug: Warfarin', 'Device: On-X Aortic Mechanical Valve']}], 'interventions': [{'name': 'Apixaban 5 MG', 'type': 'DRUG', 'description': 'For patients that do NOT meet the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)', 'armGroupLabels': ['Apixaban']}, {'name': 'Apixaban 2.5 MG', 'type': 'DRUG', 'description': 'For patients that meet at least 2 of the following criteria\n\n* age ≥ 80 years\n* weight ≤ 60 kilograms\n* creatinine ≥ 1.5 mg/dL (133 micromol/L)', 'armGroupLabels': ['Apixaban']}, {'name': 'Warfarin', 'type': 'DRUG', 'description': 'Active Control Intervention', 'armGroupLabels': ['Warfarin']}, {'name': 'On-X Aortic Mechanical Valve', 'type': 'DEVICE', 'otherNames': ['On-X Ascending Aortic Prosthesis (AAP)'], 'description': 'Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.', 'armGroupLabels': ['Apixaban', 'Warfarin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Tucson Heart Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'CHI St. Vincent Heart Institute', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92354', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'Loma Linda University Medical Center', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}, {'zip': '94305', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Medical Center', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale- New Haven Hospital', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33756', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Baycare Health / Morton Plant Hospital', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32608', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Hospital (University of Florida Health)', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'AdventHealth Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': 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Hospital', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55422', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55902', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': "Saint Luke's Hospital", 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63105', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University Medical Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Baptist Medical Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Mount Sinai- St. Luke's Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NewYork-Presbyterian/ Weill Cornell Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '12601', 'city': 'Poughkeepsie', 'state': 'New York', 'country': 'United States', 'facility': 'Vassar Brothers Medical Center', 'geoPoint': {'lat': 41.70037, 'lon': -73.92097}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Atrium Health Carolinas Medical Center (CMC)', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27708', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43606', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'ProMedica Toledo Hospital', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Heart Hospital', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': 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Clements Jr. University Hospital', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '76107', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'TCU School of Medicine', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'The Heart Hospital at Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '23229', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': "Henrico Doctors' Hospital", 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '24014', 'city': 'Roanoke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Carilion Roanoke Memorial Hospital', 'geoPoint': {'lat': 37.27097, 'lon': -79.94143}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98195', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Tacoma General Hospital', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226', 'city': 'Wauwatosa', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.04946, 'lon': -88.00759}}], 'overallOfficials': [{'name': 'Lars Svensson, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Steering Committee'}, {'name': 'John Alexander, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Steering Committee'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Artivion Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Duke Clinical Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}