MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

Stroke, Ischemic Clinical Trial

— MOSES  

Official title:

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03961334
• Other study ID #: MOSES
• Status: Recruiting
• Phase: Phase 3
• Start date: December 5, 2019
• Est. completion date: January 31, 2026

Study information

• Verified date: August 2023
• Source: University of Zurich
• Contact: Mira Katan, Prof.Dr.med.
• Phone: +41 61 328 45 06
• Email: mira.katan[@]usb.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 620
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Stroke
• Stroke, Ischemic

Intervention

Drug:
• Dabigatran
150mg 2x/d
• Apixaban
5mg 2x/d
• Edoxaban
60mg 1x/d
• Aspirin
100mg 1x/d
• Clopidogrel
75mg 1x/d

Locations

Country	Name	City	State
Greece	Attikon University Hospital	Athens
Norway	Oslo University Hospital - Ullevål	Oslo
Spain	Hospital de la Santa Creu I Sant Pau	Barcelona
Spain	Campus Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Switzerland	Kantonsspital Aarau, Department of Neurology	Aarau	Argau
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	St.Gallen
Switzerland	Kantonsspital Winterthur	Winterthur
Switzerland	University Hospital of Zurich, Department of Neurology	Zurich
Switzerland	Klinik Hirslanden	Zürich
United Kingdom	Queen Elizabeth University Hospital	Glasgow

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation

Countries where clinical trial is conducted

Greece,  Norway,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent stroke of any type	The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke)	within one year after index stroke
Secondary	Composite of major bleeding, recurrent stroke and/or vascular death	Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first)	within one year after index stroke
Secondary	Major bleeding, recurrent stroke and/or vascular death as single components	Each single component of the composite in outcome 2 (major bleeding, recurrent stroke and/or vascular death)	within one year after index stroke