MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention
NCT ID: NCT03961334
Last Updated: 2023-08-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
620 participants
INTERVENTIONAL
2019-12-05
2026-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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DOACs
Direct oral anticoagulants
Dabigatran
150mg 2x/d
Apixaban
5mg 2x/d
Edoxaban
60mg 1x/d
Antiplatelets
SOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.
Aspirin
100mg 1x/d
Clopidogrel
75mg 1x/d
Interventions
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Dabigatran
150mg 2x/d
Apixaban
5mg 2x/d
Edoxaban
60mg 1x/d
Aspirin
100mg 1x/d
Clopidogrel
75mg 1x/d
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* level ≥200pmol/L within 72 hours from symptom onset
* Age ≥ 18 years
* Signed informed consent
Exclusion Criteria
* 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
* 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.)
* Patients undergoing planned procedures where therapy with a DOAC is a contraindication (e.g. surgery)
* Previous intracranial hemorrhage in the last year
* Evidence of severe cerebral amyloid angiopathy if MRI scan performed
* Chronic kidney disease with creatinin clearance \<30ml/min and or subject who requires haemodialysis or peritoneal dialysis
* 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)
* Active infective endocarditis
* CT or MRI evidence of cerebral vasculitis
* Known allergy or intolerance to antiplatelets or DOACs
* Female who is pregnant or lactating or has a positive pregnancy test at time of admission
* Current participation in another drug trial
18 Years
ALL
No
Sponsors
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Swiss National Science Foundation
OTHER
University of Zurich
OTHER
Responsible Party
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Mira Katan
Prof. Dr. med.
Principal Investigators
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Mira Katan, Prof.Dr.med.
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Basel, Switzerland
Locations
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Attikon University Hospital
Athens, , Greece
Oslo University Hospital - Ullevål
Oslo, , Norway
Hospital de la Santa Creu I Sant Pau
Barcelona, , Spain
Hospital Universitario Virgen Macarena
Seville, , Spain
Campus Hospital Universitario Virgen del Rocío
Seville, , Spain
Kantonsspital Aarau, Department of Neurology
Aarau, Canton of Aargau, Switzerland
University Hospital of Basel
Basel, , Switzerland
University Hospital of Bern/Inselspital
Bern, , Switzerland
Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale
Lugano, , Switzerland
Kantonsspital St.Gallen
Sankt Gallen, , Switzerland
Kantonsspital Winterthur
Winterthur, , Switzerland
Klinik Hirslanden
Zurich, , Switzerland
University Hospital of Zurich, Department of Neurology
Zurich, , Switzerland
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MOSES
Identifier Type: -
Identifier Source: org_study_id
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