Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-29 @ 1:08 AM
Study NCT ID:
NCT04437303
Status:
COMPLETED
Last Update Posted:
2024-05-31
First Post:
2020-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D020521', 'term': 'Stroke'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D006331', 'term': 'Heart Diseases'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014694', 'term': 'Ventricular Outflow Obstruction'}, {'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': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 858}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-05-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-30', 'studyFirstSubmitDate': '2020-05-19', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2024-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'New York Heart Association class for heart failure', 'timeFrame': '30 days'}, {'measure': 'Rehospitalisation', 'timeFrame': '30 days'}, {'measure': 'Permanent pacemaker implantation', 'timeFrame': '30 days'}, {'measure': 'Bleeding', 'timeFrame': '30 days', 'description': 'As classified by Bleeding Academic Research Consortium (BARC) criteria'}], 'primaryOutcomes': [{'measure': 'Net adverse clinical events', 'timeFrame': '30 days', 'description': 'A composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding complications at 30 days post TAVI as defined by the VARC-3 criteria'}], 'secondaryOutcomes': [{'measure': 'Procedure related primary endpoints', 'timeFrame': '30 days', 'description': 'Cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding complications as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee'}, {'measure': 'Procedure related bleeding complications', 'timeFrame': '30 days', 'description': 'Type 1-4 bleeding as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee'}, {'measure': 'Procedure related thromboembolic complications', 'timeFrame': '30 days', 'description': 'All stroke (except haemorrhagic), TIA, myocardial infarction, systemic embolism (vascular complications: distal embolization (non-cerebral) from a vascular source) as defined by the VARC-3 criteria considered procedure related as adjudicated by the clinical event committee'}, {'measure': 'Thromboembolic complications', 'timeFrame': '30 days', 'description': 'All stroke (except haemorrhagic), TIA, myocardial infarction and systemic embolism (vascular complications: distal embolization (non-cerebral) from a vascular source) as defined by the VARC-3 criteria'}, {'measure': 'Neurologic events', 'timeFrame': '30 days', 'description': 'Overt CNS injury, covert CNS injury, neurologic dysfunction (acutely symptomatic) without CNS injury as defined by the VARC-3 criteria'}, {'measure': 'Cerebrovascular events', 'timeFrame': '30 days', 'description': 'All stroke and TIA as defined by the VARC-3 criteria.'}, {'measure': 'Stroke', 'timeFrame': '30 days', 'description': 'All stroke as defined by the VARC-3 criteria'}, {'measure': 'Bleeding complications', 'timeFrame': '30 days', 'description': 'Type 1-4 bleeding as defined by the VARC-3 criteria'}, {'measure': 'Early safety', 'timeFrame': '30 days', 'description': 'Freedom from all-cause mortality, all stroke, VARC type 2-4 bleeding, major vascular, access-related, or cardiac structural complication, acute kidney injury stage 3 or 4, moderate or severe aortic regurgitation, new permanent pacemaker due to procedure related conduction abnormalities, surgery or intervention related to the device as defined by the VARC-3 criteria'}, {'measure': 'Clinical efficacy', 'timeFrame': '30 days', 'description': 'Freedom from: all-cause mortality, all stroke, hospitalization for procedure- or valve-related causes, KCCQ Overall Summary Score \\<45 or decline from baseline of \\>10 point as defined by the VARC-3 criteria'}, {'measure': 'All-cause death', 'timeFrame': '30 days'}, {'measure': 'Cardiovascular death', 'timeFrame': '30 days'}, {'measure': 'Quality of Life', 'timeFrame': '30 days and 90 days', 'description': 'Assessed by Short Form(SF)-12, Kansas City Cardiomyopathy Questionnaire (KCCQ), and Toronto aortic stenosis quality of life questionnaire (TASQ)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcatheter Aortic Valve Implantation (TAVI)', 'Transcatheter Aortic Valve Replacement (TAVR)', 'Aortic Valve Disease', 'Aortic Valve Stenosis', 'Stroke', 'Bleeding', 'Vascular Complications', 'Myocardial Infarction', 'Thrombosis Embolism', 'Heart Diseases', 'Oral Anticoagulation', 'Warfarin', 'Vitamin K Antagonist', 'Direct Acting Oral Anticoagulants', 'Protamine'], 'conditions': ['Aortic Valve Disease', 'Aortic Valve Stenosis', 'Stroke', 'Bleeding', 'Vascular Complications', 'Myocardial Infarction', 'Thrombosis Embolism']}, 'referencesModule': {'references': [{'pmid': '41128170', 'type': 'DERIVED', 'citation': 'van Bergeijk KH, Overduin DC, Venema CS, van Ginkel DJ, van der Werf HW, van den Heuvel AFM, Voors AA, Wykrzykowska JJ, Ten Berg JM. Sex Differences in Transcatheter Aortic Valve Implantation Outcomes in Patients on Oral Anticoagulants: A Popular PAUSE TAVI SubAnalysis. J Am Heart Assoc. 2025 Nov 4;14(21):e043448. doi: 10.1161/JAHA.125.043448. Epub 2025 Oct 23.'}, {'pmid': '39216096', 'type': 'DERIVED', 'citation': "van Ginkel DJ, Bor WL, Aarts HM, Dubois C, De Backer O, Rooijakkers MJP, Rosseel L, Veenstra L, van der Kley F, van Bergeijk KH, Van Mieghem NM, Agostoni P, Voskuil M, Schotborgh CE, IJsselmuiden AJJ, Van Der Heyden JAS, Hermanides RS, Barbato E, Mylotte D, Fabris E, Frambach P, Dujardin K, Ferdinande B, Peper J, Rensing BJWM, Timmers L, Swaans MJ, Brouwer J, Nijenhuis VJ, Overduin DC, Adriaenssens T, Kobari Y, Vriesendorp PA, Montero-Cabezas JM, El Jattari H, Halim J, Van den Branden BJL, Leonora R, Vanderheyden M, Lauterbach M, Wykrzykowska JJ, van 't Hof AWJ, van Royen N, Tijssen JGP, Delewi R, Ten Berg JM; POPular PAUSE TAVI Investigators.; POPular PAUSE TAVI Investigators. Continuation versus Interruption of Oral Anticoagulation during TAVI. N Engl J Med. 2025 Jan 30;392(5):438-449. doi: 10.1056/NEJMoa2407794. Epub 2024 Aug 31."}]}, 'descriptionModule': {'briefSummary': 'Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen.\n\nHypothesis:\n\nPeriprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned transfemoral or transsubclavian transcatheter aortic valve implantation procedure\n* Uses oral anticoagulation at screening\n* Provided written informed consent\n\nExclusion Criteria:\n\nPatients at high risk for thromboembolism for whom interruption of oral anticoagulants is no option, i.e.:\n\n* Mechanical heart valve prosthesis\n* Intracardiac thrombus\n* \\< 3 months after venous thromboembolism\n* \\< 6 months after transient ischemic attack or stroke in patients with atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT04437303', 'briefTitle': 'Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)', 'organization': {'class': 'OTHER', 'fullName': 'St. Antonius Hospital'}, 'officialTitle': 'Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)', 'orgStudyIdInfo': {'id': 'NL73805.100.20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Continuation of oral anticoagulants', 'interventionNames': ['Drug: Continuation of oral anticoagulants']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Interruption of oral anticoagulants', 'interventionNames': ['Drug: Interruption of oral anticoagulants']}], 'interventions': [{'name': 'Continuation of oral anticoagulants', 'type': 'DRUG', 'description': 'Oral anticoagulant treatment will not be interrupted before the procedure.', 'armGroupLabels': ['Continuation of oral anticoagulants']}, {'name': 'Interruption of oral anticoagulants', 'type': 'DRUG', 'description': 'Peri-operative interruption of oral anticoagulants will be according to the Dutch guideline on antithrombotic therapy.\n\n* For direct oral anticoagulant users this will be in general 48 hours before the procedure, except for Dabigatran users with renal insufficiency: with estimated glomerular filtration rate 50-80 mL/min/1.73m\\^2 72 hours and with estimated glomerular filtration rate 30-50 mL/min/1.73m\\^2 96 hours before procedure.\n* For vitamin K antagonist users this will be 5 days for phenprocoumon and 3 days for acenocoumarol.\n* After the procedure oral anticoagulants will be resumed after 24 hours, if deemed safe by the treating physician.', 'armGroupLabels': ['Interruption of oral anticoagulants']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aalst', 'country': 'Belgium', 'facility': 'A.S.Z. Hospital', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Aalst', 'country': 'Belgium', 'facility': 'O.L.V. Hospital', 'geoPoint': {'lat': 50.93604, 'lon': 4.0355}}, {'city': 'Antwerp', 'country': 'Belgium', 'facility': 'ZNA Middelheim', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Bruges', 'country': 'Belgium', 'facility': 'AZ Sint-Jan', 'geoPoint': {'lat': 51.20892, 'lon': 3.22424}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'East Limburg Hospital', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Leuven', 'country': 'Belgium', 'facility': 'University Hospital Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '8800', 'city': 'Roeselare', 'country': 'Belgium', 'facility': 'AZ Delta', 'geoPoint': {'lat': 50.94653, 'lon': 3.12269}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Rigshospitalet Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'University Hospital Galway', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Trieste', 'country': 'Italy', 'facility': 'Azienda Sanitaria Universitaria Integrata di Trieste', 'geoPoint': {'lat': 45.64953, 'lon': 13.77678}}, {'city': 'Luxembourg', 'country': 'Luxembourg', 'facility': 'National Institute of Cardiac Surgery and Interventional Cardiology', 'geoPoint': {'lat': 49.60982, 'lon': 6.13268}}, {'zip': '3435CM', 'city': 'Nieuwegein', 'state': 'Utrecht', 'country': 'Netherlands', 'facility': 'St. Antonius Ziekenhuis', 'geoPoint': {'lat': 52.02917, 'lon': 5.08056}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Breda', 'country': 'Netherlands', 'facility': 'Amphia Hospital', 'geoPoint': {'lat': 51.58656, 'lon': 4.77596}}, {'city': 'Groningen', 'country': 'Netherlands', 'facility': 'UMC Groningen', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}, {'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leiden University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht UMC+', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}, {'city': 'Nijmegen', 'country': 'Netherlands', 'facility': 'Radboud UMC', 'geoPoint': {'lat': 51.8425, 'lon': 5.85278}}, {'city': 'Rotterdam', 'country': 'Netherlands', 'facility': 'Erasmus MC', 'geoPoint': {'lat': 51.9225, 'lon': 4.47917}}, {'city': 'The Hague', 'country': 'Netherlands', 'facility': 'Haga Hospital', 'geoPoint': {'lat': 52.07667, 'lon': 4.29861}}, {'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'city': 'Zwolle', 'country': 'Netherlands', 'facility': 'Isala', 'geoPoint': {'lat': 52.5125, 'lon': 6.09444}}], 'overallOfficials': [{'name': 'Jurriën M ten Berg, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'St. Antonius Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Antonius Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor dr.', 'investigatorFullName': 'Jurriën M. ten Berg, MD, PhD', 'investigatorAffiliation': 'St. Antonius Hospital'}}}}