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出境医 / 临床实验 / MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention (MOSES)

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention (MOSES)

Study Description
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) versus antiplatelets as preventive treatment.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Drug: Dabigatran Drug: Apixaban Drug: Edoxaban Drug: Aspirin Drug: Clopidogrel Phase 3

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 control (antiplatelet) or the experimental (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.
Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Blinded endpoint assessment by independent CEC
Primary Purpose: 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
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023
Arms and Interventions
Arm Intervention/treatment
Experimental: DOACs
Direct oral anticoagulants
 Drug: Dabigatran
150mg 2x/d
Other Name: Pradaxa

Drug: Apixaban
5mg 2x/d
Other Name: Eliquis

Drug: Edoxaban
60mg 1x/d
Other Name: Lixiana
Active Comparator: Antiplatelets
Antiplatelets
 Drug: Aspirin
100mg 1x/d
Other Name: Aspirin cardio

Drug: Clopidogrel
75mg 1x/d
Outcome Measures
Primary Outcome Measures :
  1. Recurrent stroke of any type [ Time Frame: within one year after index stroke ]
    The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke)


Secondary Outcome Measures :
  1. Composite of major bleeding, recurrent stroke and/or vascular death [ Time Frame: within one year after index stroke ]
    Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first)

  2. Major bleeding, recurrent stroke and/or vascular death as single components [ Time Frame: within one year after index stroke ]
    Each single component of the composite in outcome 2 (major bleeding, recurrent stroke and/or vascular death)


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of ischemic stroke
  • elevated MRproANP level within 24 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
Contacts and Locations

Contacts
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Contact: Mira Katan, PD Dr. med. +41 44 255 47 32 mira.katan@usz.ch

Locations
Layout table for location information
Germany
Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Contact: Götz Thomalla, MD       thomalla@uke.de   
Principal Investigator: Götz Thomalla, Prof.Dr.med.         
Norway
Oslo University Hospital - Ullevål Not yet recruiting
Oslo, Norway, 0424
Contact: Else Charlotte Sandset, Dr. med.       else@sandset.net   
Principal Investigator: Else Charlotte Sandset, Dr. med.         
Spain
Hospital de la Santa Creu I Sant Pau Not yet recruiting
Barcelona, Spain, 08041
Contact: Joan Montaner, MD       jmontaner-ibis@us.es   
Principal Investigator: Joan Montaner, Prof.Dr.med.         
Hospital Universitario Virgen Macarena Not yet recruiting
Sevilla, Spain, 41009
Contact: Joan Montaner, MD       jmontaner-ibis@us.es   
Principal Investigator: Joan Montaner, Prof. Dr. med.         
Campus Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41013
Contact: Joan Montaner, MD       jmontaner-ibis@us.es   
Principal Investigator: Joan Montaner, Prof.Dr.med.         
Switzerland
Kantonsspital Aarau, Department of Neurology Recruiting
Aarau, Argau, Switzerland, 5001
Contact: Timo Kahles, MD       timo.kahles@ksa.ch   
Principal Investigator: Timo Kahles, Dr. med.         
University Hospital of Basel Recruiting
Basel, Switzerland, 4031
Contact: Gian Marco De Marchis, MD       gian.demarchis@usb.ch   
Principal Investigator: Gian Marco De Marchis, PD Dr. med.         
University Hospital of Bern/Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Urs Fischer, MD       urs.fischer@insel.ch   
Principal Investigator: Urs Fischer, Prof.Dr.med.         
Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale Recruiting
Lugano, Switzerland, 6900
Contact: Carlo Cereda, MD       carlo.cereda@eoc.ch   
Principal Investigator: Carlo Cereda, PD Dr. med.         
Kantonsspital St.Gallen Active, not recruiting
St.Gallen, Switzerland, 9007
University Hospital of Zurich, Department of Neurology Recruiting
Zurich, Switzerland, 8091
Contact: Mira Katan, PD Dr. med.       mira.katan@usz.ch   
Principal Investigator: Mira Katan, PD Dr. med.         
United Kingdom
Queen Elizabeth University Hospital Not yet recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Jesse Dawson, MD       jesse.dawson@glasgow.ac.uk   
Principal Investigator: Jesse Dawson, Prof.Dr.med.         
Sponsors and Collaborators
University of Zurich
Swiss National Science Foundation
Investigators
Layout table for investigator information
Principal Investigator: Mira Katan, PD Dr. med. University of Zurich
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE May 23, 2019
Last Update Posted Date September 22, 2020
Actual Study Start Date  ICMJE December 5, 2019
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 21, 2019) 		Recurrent stroke of any type [ Time Frame: within one year after index stroke ]
The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 22, 2020)
  • Composite of major bleeding, recurrent stroke and/or vascular death [ Time Frame: within one year after index stroke ]
    Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first)
  • Major bleeding, recurrent stroke and/or vascular death as single components [ Time Frame: within one year after index stroke ]
    Each single component of the composite in outcome 2 (major bleeding, recurrent stroke and/or vascular death)
Original Secondary Outcome Measures  ICMJE
 (submitted: May 21, 2019)
  • Composite of major bleeding, recurrent stroke and/or vascular death [ Time Frame: within 1 year after the index ischemic stroke ]
    Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first)
  • Major bleeding, recurrent stroke and/or vascular death as single components [ Time Frame: within 1 year after the index ischemic stroke ]
    Each single component of the composite in outcome 2 (major bleeding, recurrent stroke and/or vascular death)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention
Official Title  ICMJE MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial
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) versus antiplatelets 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 control (antiplatelet) or the experimental (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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Blinded endpoint assessment by independent CEC
Primary Purpose: Prevention
Condition  ICMJE Stroke, Ischemic
Intervention  ICMJE
  • Drug: Dabigatran
    150mg 2x/d
    Other Name: Pradaxa
  • Drug: Apixaban
    5mg 2x/d
    Other Name: Eliquis
  • Drug: Edoxaban
    60mg 1x/d
    Other Name: Lixiana
  • Drug: Aspirin
    100mg 1x/d
    Other Name: Aspirin cardio
  • Drug: Clopidogrel
    75mg 1x/d
Study Arms  ICMJE
  • Experimental: DOACs
    Direct oral anticoagulants
    Interventions:
    • Drug: Dabigatran
    • Drug: Apixaban
    • Drug: Edoxaban
  • Active Comparator: Antiplatelets
    Antiplatelets
    Interventions:
    • Drug: Aspirin
    • Drug: Clopidogrel
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 21, 2019) 		590
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2023
Estimated Primary Completion Date December 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of ischemic stroke
  • elevated MRproANP level within 24 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mira Katan, PD Dr. med. +41 44 255 47 32 mira.katan@usz.ch
Listed Location Countries  ICMJE Germany,   Norway,   Spain,   Switzerland,   United Kingdom
Removed Location Countries Greece
 
Administrative Information
NCT Number  ICMJE NCT03961334
Other Study ID Numbers  ICMJE MOSES
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mira Katan, University of Zurich
Study Sponsor  ICMJE University of Zurich
Collaborators  ICMJE Swiss National Science Foundation
Investigators  ICMJE
Principal Investigator: Mira Katan, PD Dr. med. University of Zurich
PRS Account University of Zurich
Verification Date September 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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