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

Primary Purpose

Stroke, Ischemic

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Dabigatran
Apixaban
Edoxaban
Aspirin
Clopidogrel
Sponsored by
University of Zurich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stroke, Ischemic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Attikon University HospitalRecruiting
  • Oslo University Hospital - Ullevål
  • Hospital de la Santa Creu I Sant PauRecruiting
  • Hospital Universitario Virgen MacarenaRecruiting
  • Campus Hospital Universitario Virgen del RocíoRecruiting
  • Kantonsspital Aarau, Department of NeurologyRecruiting
  • University Hospital of BaselRecruiting
  • University Hospital of Bern/InselspitalRecruiting
  • Ospedale Regionale di Lugano, Ente Ospedaliero CantonaleRecruiting
  • Kantonsspital St.GallenRecruiting
  • Kantonsspital Winterthur
  • University Hospital of Zurich, Department of NeurologyRecruiting
  • Klinik Hirslanden
  • Queen Elizabeth University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DOACs

Antiplatelets

Arm Description

Direct oral anticoagulants

SOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.

Outcomes

Primary Outcome Measures

Recurrent stroke of any type
The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke)

Secondary Outcome Measures

Composite of major bleeding, recurrent stroke and/or vascular death
Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first)
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)

Full Information

First Posted
May 16, 2019
Last Updated
August 11, 2023
Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03961334
Brief Title
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2019 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Zurich
Collaborators
Swiss National Science Foundation

4. Oversight

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
Data Monitoring Committee
Yes

5. 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) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Ischemic

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Blinded endpoint assessment by independent CEC
Allocation
Randomized
Enrollment
620 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
DOACs
Arm Type
Experimental
Arm Description
Direct oral anticoagulants
Arm Title
Antiplatelets
Arm Type
Active Comparator
Arm Description
SOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.
Intervention Type
Drug
Intervention Name(s)
Dabigatran
Other Intervention Name(s)
Pradaxa
Intervention Description
150mg 2x/d
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis
Intervention Description
5mg 2x/d
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Other Intervention Name(s)
Lixiana
Intervention Description
60mg 1x/d
Intervention Type
Drug
Intervention Name(s)
Aspirin
Other Intervention Name(s)
Aspirin cardio
Intervention Description
100mg 1x/d
Intervention Type
Drug
Intervention Name(s)
Clopidogrel
Intervention Description
75mg 1x/d
Primary Outcome Measure Information:
Title
Recurrent stroke of any type
Description
The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke)
Time Frame
within one year after index stroke
Secondary Outcome Measure Information:
Title
Composite of major bleeding, recurrent stroke and/or vascular death
Description
Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first)
Time Frame
within one year after index stroke
Title
Major bleeding, recurrent stroke and/or vascular death as single components
Description
Each single component of the composite in outcome 2 (major bleeding, recurrent stroke and/or vascular death)
Time Frame
within one year after index stroke

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mira Katan, Prof.Dr.med.
Phone
+41 61 328 45 06
Email
mira.katan@usb.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mira Katan, Prof.Dr.med.
Organizational Affiliation
University Hospital, Basel, Switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Attikon University Hospital
City
Athens
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georgios Tsivgoulis, Prof.Dr.med.
Email
gtsivou@med.uoa.gr
First Name & Middle Initial & Last Name & Degree
Georgios Tsivgoulis, Prof.Dr.med.
Facility Name
Oslo University Hospital - Ullevål
City
Oslo
ZIP/Postal Code
0424
Country
Norway
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Else Charlotte Sandset, Dr. med.
Email
else@sandset.net
First Name & Middle Initial & Last Name & Degree
Else Charlotte Sandset, Dr. med.
Facility Name
Hospital de la Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Montaner, MD
Email
jmontaner-ibis@us.es
First Name & Middle Initial & Last Name & Degree
Joan Montaner, Prof.Dr.med.
Facility Name
Hospital Universitario Virgen Macarena
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Montaner, MD
Email
jmontaner-ibis@us.es
First Name & Middle Initial & Last Name & Degree
Joan Montaner, Prof.Dr.med.
Facility Name
Campus Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joan Montaner, MD
Email
jmontaner-ibis@us.es
First Name & Middle Initial & Last Name & Degree
Joan Montaner, Prof.Dr.med.
Facility Name
Kantonsspital Aarau, Department of Neurology
City
Aarau
State/Province
Argau
ZIP/Postal Code
5001
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Timo Kahles, MD
Email
timo.kahles@ksa.ch
First Name & Middle Initial & Last Name & Degree
Timo Kahles, Dr. med.
Facility Name
University Hospital of Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mira Katan, Prof.Dr.med.
Email
Mira.katan@usb.ch
First Name & Middle Initial & Last Name & Degree
Mira Katan, Prof.Dr.med.
Facility Name
University Hospital of Bern/Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Seiffge, PD Dr. med.
Email
david.seiffge@insel.ch
First Name & Middle Initial & Last Name & Degree
David Seiffge, PD Dr. med.
Facility Name
Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale
City
Lugano
ZIP/Postal Code
6900
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlo Cereda, MD
Email
carlo.cereda@eoc.ch
First Name & Middle Initial & Last Name & Degree
Carlo Cereda, PD Dr. med.
Facility Name
Kantonsspital St.Gallen
City
St.Gallen
ZIP/Postal Code
9007
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Georg Kägi, MD
Email
georg.kaegi@kssg.ch
First Name & Middle Initial & Last Name & Degree
Georg Kägi, PD Dr. med.
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Biljana Rodic-Tatic, Dr. med.
Email
biljana.rodic@ksw.ch
First Name & Middle Initial & Last Name & Degree
Biljana Rodic-Tatic, Dr. med.
Facility Name
University Hospital of Zurich, Department of Neurology
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Wegener, Prof.Dr.med.
Email
susanne.wegener@usz.ch
First Name & Middle Initial & Last Name & Degree
Susanne Wegener, Prof.Dr.med.
Facility Name
Klinik Hirslanden
City
Zürich
ZIP/Postal Code
8032
Country
Switzerland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nils Peters, Prof.Dr.med.
Email
nils.peters@hirslanden.ch
First Name & Middle Initial & Last Name & Degree
Nils Peters, Prof.Dr.med.
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesse Dawson, MD
Email
jesse.dawson@glasgow.ac.uk
First Name & Middle Initial & Last Name & Degree
Jesse Dawson, Prof.Dr.med.

12. IPD Sharing Statement

Plan to Share IPD
No

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MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

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