Clinical trial NCT03961334: MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention
Official title: MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Stroke, Ischemic
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2019-05-23
Enrollment: 620
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ischemic stroke
* level ≥200pmol/L within 72 hours from symptom onset
* Age ≥ 18 years
* Signed informed consent

Exclusion Criteria:

* History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds during heart-rhythm monitoring prior to randomization
* 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

Primary outcomes:
measure: Recurrent stroke of any type
timeFrame: within one year after index stroke
Secondary outcomes:
measure: Composite of major bleeding, recurrent stroke and/or vascular death
timeFrame: within one year after index stroke
measure: Major bleeding, recurrent stroke and/or vascular death as single components
timeFrame: within one year after index stroke
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Attikon University Hospital
city: Oslo
country: Norway
facility: Oslo University Hospital - Ullevål
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu I Sant Pau
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Campus Hospital Universitario Virgen del Rocío
city: Aarau
country: Switzerland
facility: Kantonsspital Aarau, Department of Neurology
state: Argau
city: Basel
country: Switzerland
facility: University Hospital of Basel
city: Bern
country: Switzerland
facility: University Hospital of Bern/Inselspital
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale
city: St.Gallen
country: Switzerland
facility: Kantonsspital St.Gallen
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zurich
country: Switzerland
facility: University Hospital of Zurich, Department of Neurology
city: Zürich
country: Switzerland
facility: Klinik Hirslanden
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Mira Katan, Prof.Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: