Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT03488420
Status:
COMPLETED
Last Update Posted:
2025-04-06
First Post:
2018-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Canadian EdoxAban(Lixiana®) Registry in Patients With ATrial Fibrillation/Flutter With Confirmed ValvUlar HeaRt DiseasE
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C552171', 'term': 'edoxaban'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-03', 'studyFirstSubmitDate': '2018-03-20', 'studyFirstSubmitQcDate': '2018-03-28', 'lastUpdatePostDateStruct': {'date': '2025-04-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Characterization of patients with diagnosed or confirmed atrial fibrillation (AF) and/or atrial flutter (AFL) with valvular heart disease (VHD), within the last 12 months', 'timeFrame': '2 years'}, {'measure': 'Patient treatment satisfaction using Anti-Clot Treatment Scale (ACTS)', 'timeFrame': '2 years'}, {'measure': 'Cognitive function using the Montreal Cognitive Assessment (MoCA) test', 'timeFrame': '2 years'}, {'measure': 'Compliance of subjects to edoxaban treatment', 'timeFrame': '2 years'}, {'measure': 'Reasons for choosing edoxaban and reasons for the dosage', 'timeFrame': '2 years'}, {'measure': 'Percentage of patients on appropriate dosage of edoxaban (60 mg and 30 mg if dose reduction criteria)', 'timeFrame': '2 years'}, {'measure': 'Stroke (hemorrhagic stroke, ischemic stroke), transient ischemic attack (TIA) and systemic embolism events (SEE)', 'timeFrame': '2 years'}, {'measure': 'Bleeding (Frequency, Location, Severity, Type of intervention and Outcome)', 'timeFrame': '2 years'}, {'measure': 'Death (CV and non-CV)', 'timeFrame': '2 years'}, {'measure': 'Adverse events (AEs) and serious adverse events (SAEs) related to edoxaban', 'timeFrame': '2 years'}, {'measure': 'Physician satisfaction with regards to edoxaban treatment', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atrial Fibrillation and Flutter', 'Valvular Heart Disease']}, 'descriptionModule': {'briefSummary': 'The objective of this registry is the characterization of patients with atrial fibrillation (AF) and/ or atrial flutter (AFL) with confirmed VHD who are prescribed edoxaban in a real life clinical setting.', 'detailedDescription': "This is an observational, prospective, multicenter, edoxaban Canadian registry of adults (≥18) diagnosed or confirmed with AF and/or AFL with VHD, within the last 12 months, according to local standard procedures and judged by the investigator to be at risk of stroke and in whom anticoagulation with NOAC is clinically indicated and who are prescribed edoxaban. A total of about 300 patients will be enrolled from approximately 10 sites in Quebec. Patients will be treated according to standard local practices. There is no formal interventions. Treatment decisions are left to the physician's discretion.\n\nRegistry data will be collected by the investigator or delegate at baseline, 6, 12 and 24 months and recorded in the electronic Case Report Form (eCRF).\n\nData available in the patient's file will be collected. The only procedure to be performed in the context of this registry is the completion of questionnaires: the Montreal Cognitive Assessment (MoCA©) test and the Anti-Clot-Treatment Scale (ACTS-Q) questionnaire."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patient diagnosed or confirmed with Atrial Fibrillation (AF) and/or atrial flutter (AFL) with valvular heart disease (VHD) within the last 12 months, according to local standard procedures, judged by the investigator to be at risk of stroke and in whom anticoagulation with a NOAC drugs is clinically indicated and who are prescribed edoxaban.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients aged ≥ 18 years at baseline (signing of consent);\n2. Willing and able to provide written informed consent;\n3. Patient diagnosed or confirmed with AF and/or AFL within the last 12 months of signed consent form;\n4. Patient with VHD confirmed by echocardiography within the last 36 months of signed consent form except for mitral stenosis that must be confirmed within the last 12 months;\n5. Patient at risk for stroke in whom a long term oral anticoagulation is indicated and who are prescribed edoxaban.\n\nExclusion Criteria:\n\n1. Patients with AF and/or AFL secondary to reversible cause;\n2. Patients with a mechanical heart valve or rheumatic mitral stenosis, or moderate and severe non rheumatic mitral stenosis;\n3. Patients planned to have an intervention for valvular heart disease in the next 12 months;\n4. Pregnant or breastfeeding women.\n5. Short term anticoagulation post cardioversion or ablation.'}, 'identificationModule': {'nctId': 'NCT03488420', 'acronym': 'CAPTURE', 'briefTitle': 'Canadian EdoxAban(Lixiana®) Registry in Patients With ATrial Fibrillation/Flutter With Confirmed ValvUlar HeaRt DiseasE', 'organization': {'class': 'OTHER', 'fullName': 'Montreal Heart Institute'}, 'officialTitle': 'Canadian EdoxAban (Lixiana®) Registry in Patients With ATrial Fibrillation and/or ATrial Flutter With Confirmed ValvUlar HeaRt DiseasE (CAPTURE)', 'orgStudyIdInfo': {'id': 'MHICC-2017-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atrial Fibrillation and/or Atrial Flutter', 'description': 'Subjects taking edoxaban 30mg or 60 mg will be followed for 2 years. Subjects will perform the Montreal Cognitive Assessment (MoCA) Test at baseline and 1-year follow up. They will also answer the Anti-Clot Treatment questionnaire (ACTS-Q) at 1-year.', 'interventionNames': ['Drug: Edoxaban Pill']}], 'interventions': [{'name': 'Edoxaban Pill', 'type': 'DRUG', 'otherNames': ['Lixiana', 'edoxaban tosylate monhydrate'], 'description': 'Subjects will be taking edoxaban 30 or 60 mg', 'armGroupLabels': ['Atrial Fibrillation and/or Atrial Flutter']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Granby', 'state': 'Quebec', 'country': 'Canada', 'facility': "CIUSSS de l'Estrie-CHUS-Centre Haute-Yamaska-hôpital de Granby", 'geoPoint': {'lat': 45.40008, 'lon': -72.73243}}, {'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSS de la Montérégie Centre', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'city': 'Laval', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSS de Laval', 'geoPoint': {'lat': 45.56995, 'lon': -73.692}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Montreal Heart Institute', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'IUCPQ', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}, {'city': 'Rimouski', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSS du Bas-Saint-Laurent/Hôpital Régional de Rimouski', 'geoPoint': {'lat': 48.44879, 'lon': -68.52396}}, {'zip': 'G5Y 4T8', 'city': 'Saint-Georges', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CISSS de Chaudière-Appalaches - Hopital Saint-Georges', 'geoPoint': {'lat': 46.11353, 'lon': -70.66526}}, {'city': 'Sherbrooke', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre Hospitalier Universitaire de Sherbrooke', 'geoPoint': {'lat': 45.40008, 'lon': -71.89908}}, {'city': 'Trois-Rivières', 'state': 'Quebec', 'country': 'Canada', 'facility': 'CIUSSS de la Mauricie-et-du-Centre-du-Québec', 'geoPoint': {'lat': 46.34515, 'lon': -72.5477}}], 'overallOfficials': [{'name': 'Katia Dyrda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Montreal Heart Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Montreal Heart Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Servier', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}