Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 12:08 PM
Study NCT ID:
NCT03961334
Status:
RECRUITING
Last Update Posted:
2023-08-16
First Post:
2019-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Germany']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D020521', 'term': 'Stroke'}, {'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': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069604', 'term': 'Dabigatran'}, {'id': 'C522181', 'term': 'apixaban'}, {'id': 'C552171', 'term': 'edoxaban'}, {'id': 'D001241', 'term': 'Aspirin'}, {'id': 'D000077144', 'term': 'Clopidogrel'}], 'ancestors': [{'id': 'D011725', 'term': 'Pyridines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D012459', 'term': 'Salicylates'}, {'id': 'D062385', 'term': 'Hydroxybenzoates'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013988', 'term': 'Ticlopidine'}, {'id': 'D058924', 'term': 'Thienopyridines'}, {'id': 'D013876', 'term': 'Thiophenes'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Blinded endpoint assessment by independent CEC'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 620}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2026-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2019-05-16', 'studyFirstSubmitQcDate': '2019-05-21', 'lastUpdatePostDateStruct': {'date': '2023-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrent stroke of any type', 'timeFrame': 'within one year after index stroke', 'description': 'The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke)'}], 'secondaryOutcomes': [{'measure': 'Composite of major bleeding, recurrent stroke and/or vascular death', 'timeFrame': 'within one year after index stroke', 'description': 'Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first)'}, {'measure': 'Major bleeding, recurrent stroke and/or vascular death as single components', 'timeFrame': 'within one year after index stroke', 'description': 'Each single component of the composite in outcome 2 (major bleeding, recurrent stroke and/or vascular death)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': 'The present trial is addressing the question if a biologically distinct subgroup of ischemic stroke patients without known atrial fibrillation at admission, selected by a cut-off level of MRproANP concentration, which represents a underlying increased risk of cardiac thrombogenicity, benefits from direct oral anticoagulation (DOAC) within 7 days of symptom onset versus standard of care (antiplatelet) as preventive treatment.', 'detailedDescription': 'Three DOACs with marketing authorisation in Switzerland and the EU for the prevention of stroke and systemic embolism in patients with atrial fibrillation can be used. Eligible patients will be randomly assigned to either the standard of care (control) or the experimental (direct start with DOAC) arm with a ratio of 1:1. Each study participant will be observed during a follow up period within one year after index stroke.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of ischemic stroke\n* level ≥200pmol/L within 72 hours from symptom onset\n* Age ≥ 18 years\n* Signed informed consent\n\nExclusion Criteria:\n\n* History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds during heart-rhythm monitoring prior to randomization\n* Other condition that require anticoagulant therapy (e.g., venous thromboembolism) as per Investigator's judgment including therapeutical dose of low-molecular-weight heparin or heparin\n* Strong likelihood to be treated with prolonged (i.e. more than 30 days) dual antiplatelet therapy during the course of the trial (such as coronary stenting, etc.)\n* Patients undergoing planned procedures where therapy with a DOAC is a contraindication (e.g. surgery)\n* Previous intracranial hemorrhage in the last year\n* Evidence of severe cerebral amyloid angiopathy if MRI scan performed\n* Chronic kidney disease with creatinin clearance \\<30ml/min and or subject who requires haemodialysis or peritoneal dialysis\n* Known bleeding diathesis (e.g. active peptic ulcer disease , platelet count \\< 100'000/mm3 or haemoglobin \\< 9 g/dl or INR ≥ 1.7, documented haemorrhagic tendencies or blood dyscrasias)\n* Active infective endocarditis\n* CT or MRI evidence of cerebral vasculitis\n* Known allergy or intolerance to antiplatelets or DOACs\n* Female who is pregnant or lactating or has a positive pregnancy test at time of admission\n* Current participation in another drug trial"}, 'identificationModule': {'nctId': 'NCT03961334', 'acronym': 'MOSES', 'briefTitle': 'MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial', 'orgStudyIdInfo': {'id': 'MOSES'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DOACs', 'description': 'Direct oral anticoagulants', 'interventionNames': ['Drug: Dabigatran', 'Drug: Apixaban', 'Drug: Edoxaban']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Antiplatelets', 'description': 'SOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.', 'interventionNames': ['Drug: Aspirin', 'Drug: Clopidogrel']}], 'interventions': [{'name': 'Dabigatran', 'type': 'DRUG', 'otherNames': ['Pradaxa'], 'description': '150mg 2x/d', 'armGroupLabels': ['DOACs']}, {'name': 'Apixaban', 'type': 'DRUG', 'otherNames': ['Eliquis'], 'description': '5mg 2x/d', 'armGroupLabels': ['DOACs']}, {'name': 'Edoxaban', 'type': 'DRUG', 'otherNames': ['Lixiana'], 'description': '60mg 1x/d', 'armGroupLabels': ['DOACs']}, {'name': 'Aspirin', 'type': 'DRUG', 'otherNames': ['Aspirin cardio'], 'description': '100mg 1x/d', 'armGroupLabels': ['Antiplatelets']}, {'name': 'Clopidogrel', 'type': 'DRUG', 'description': '75mg 1x/d', 'armGroupLabels': ['Antiplatelets']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Georgios Tsivgoulis, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'gtsivou@med.uoa.gr'}, {'name': 'Georgios Tsivgoulis, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Attikon University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'zip': '0424', 'city': 'Oslo', 'status': 'NOT_YET_RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Else Charlotte Sandset, Dr. med.', 'role': 'CONTACT', 'email': 'else@sandset.net'}, {'name': 'Else Charlotte Sandset, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Oslo University Hospital - Ullevål', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '08041', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Montaner, MD', 'role': 'CONTACT', 'email': 'jmontaner-ibis@us.es'}, {'name': 'Joan Montaner, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de la Santa Creu I Sant Pau', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '41009', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Montaner, MD', 'role': 'CONTACT', 'email': 'jmontaner-ibis@us.es'}, {'name': 'Joan Montaner, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital Universitario Virgen Macarena', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '41013', 'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joan Montaner, MD', 'role': 'CONTACT', 'email': 'jmontaner-ibis@us.es'}, {'name': 'Joan Montaner, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Campus Hospital Universitario Virgen del Rocío', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'zip': '5001', 'city': 'Aarau', 'state': 'Canton of Aargau', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Timo Kahles, MD', 'role': 'CONTACT', 'email': 'timo.kahles@ksa.ch'}, {'name': 'Timo Kahles, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kantonsspital Aarau, Department of Neurology', 'geoPoint': {'lat': 47.39254, 'lon': 8.04422}}, {'zip': '4031', 'city': 'Basel', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Mira Katan, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'Mira.katan@usb.ch'}, {'name': 'Mira Katan, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Basel', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '3010', 'city': 'Bern', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'David Seiffge, PD Dr. med.', 'role': 'CONTACT', 'email': 'david.seiffge@insel.ch'}, {'name': 'David Seiffge, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Bern/Inselspital', 'geoPoint': {'lat': 46.94809, 'lon': 7.44744}}, {'zip': '6900', 'city': 'Lugano', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Carlo Cereda, MD', 'role': 'CONTACT', 'email': 'carlo.cereda@eoc.ch'}, {'name': 'Carlo Cereda, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale', 'geoPoint': {'lat': 46.01008, 'lon': 8.96004}}, {'zip': '9007', 'city': 'Sankt Gallen', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Georg Kägi, MD', 'role': 'CONTACT', 'email': 'georg.kaegi@kssg.ch'}, {'name': 'Georg Kägi, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}, {'zip': '8401', 'city': 'Winterthur', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Biljana Rodic-Tatic, Dr. med.', 'role': 'CONTACT', 'email': 'biljana.rodic@ksw.ch'}, {'name': 'Biljana Rodic-Tatic, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Kantonsspital Winterthur', 'geoPoint': {'lat': 47.50564, 'lon': 8.72413}}, {'zip': '8032', 'city': 'Zurich', 'status': 'NOT_YET_RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Nils Peters, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'nils.peters@hirslanden.ch'}, {'name': 'Nils Peters, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Klinik Hirslanden', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': '8091', 'city': 'Zurich', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Susanne Wegener, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'susanne.wegener@usz.ch'}, {'name': 'Susanne Wegener, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Hospital of Zurich, Department of Neurology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}, {'zip': 'G51 4TF', 'city': 'Glasgow', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Jesse Dawson, MD', 'role': 'CONTACT', 'email': 'jesse.dawson@glasgow.ac.uk'}, {'name': 'Jesse Dawson, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Elizabeth University Hospital', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'centralContacts': [{'name': 'Mira Katan, Prof.Dr.med.', 'role': 'CONTACT', 'email': 'mira.katan@usb.ch', 'phone': '+41 61 328 45 06'}], 'overallOfficials': [{'name': 'Mira Katan, Prof.Dr.med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Basel, Switzerland'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Swiss National Science Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med.', 'investigatorFullName': 'Mira Katan', 'investigatorAffiliation': 'University of Zurich'}}}}