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

August 11, 2023 updated by: Mira Katan, University of Zurich

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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.

Study Type

Interventional

Enrollment (Estimated)

620

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mira Katan, Prof.Dr.med.
  • Phone Number: +41 61 328 45 06
  • Email: mira.katan@usb.ch

Study Locations

  • Greece
      • Athens, Greece, 12462
        • Recruiting
        • Attikon University Hospital
        • Contact:
        • Principal Investigator:
          • Georgios Tsivgoulis, Prof.Dr.med.
  • Norway
      • Oslo, Norway, 0424
        • Not yet recruiting
        • Oslo University Hospital - Ullevål
        • Contact:
        • Principal Investigator:
          • Else Charlotte Sandset, Dr. med.
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de la Santa Creu i Sant Pau
        • Contact:
        • Principal Investigator:
          • Joan Montaner, Prof.Dr.med.
      • Sevilla, Spain, 41009
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
        • Principal Investigator:
          • Joan Montaner, Prof.Dr.med.
      • Sevilla, Spain, 41013
        • Recruiting
        • Campus Hospital Universitario Virgen del Rocio
        • Contact:
        • Principal Investigator:
          • Joan Montaner, Prof.Dr.med.
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • University Hospital of Basel
        • Contact:
        • Principal Investigator:
          • Mira Katan, Prof.Dr.med.
      • Bern, Switzerland, 3010
        • Recruiting
        • University Hospital of Bern/Inselspital
        • Contact:
        • Principal Investigator:
          • David Seiffge, PD Dr. med.
      • Lugano, Switzerland, 6900
        • Recruiting
        • Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale
        • Contact:
        • Principal Investigator:
          • Carlo Cereda, PD Dr. med.
      • St.Gallen, Switzerland, 9007
        • Recruiting
        • Kantonsspital St.Gallen
        • Contact:
        • Principal Investigator:
          • Georg Kägi, PD Dr. med.
      • Winterthur, Switzerland, 8401
        • Not yet recruiting
        • Kantonsspital Winterthur
        • Contact:
        • Principal Investigator:
          • Biljana Rodic-Tatic, Dr. med.
      • Zurich, Switzerland, 8091
        • Recruiting
        • University Hospital of Zurich, Department of Neurology
        • Contact:
        • Principal Investigator:
          • Susanne Wegener, Prof.Dr.med.
      • Zürich, Switzerland, 8032
        • Not yet recruiting
        • Klinik Hirslanden
        • Contact:
        • Principal Investigator:
          • Nils Peters, Prof.Dr.med.
    • Argau
      • Aarau, Argau, Switzerland, 5001
        • Recruiting
        • Kantonsspital Aarau, Department of Neurology
        • Contact:
        • Principal Investigator:
          • Timo Kahles, Dr. med.
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Not yet recruiting
        • Queen Elizabeth University Hospital
        • Contact:
        • Principal Investigator:
          • Jesse Dawson, Prof.Dr.med.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DOACs
Direct oral anticoagulants
Drug: Dabigatran
150mg 2x/d
Other Names:
  • Pradaxa
Drug: Apixaban
5mg 2x/d
Other Names:
  • Eliquis
Drug: Edoxaban
60mg 1x/d
Other Names:
  • Lixiana
Active Comparator: Antiplatelets
SOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.
Drug: Aspirin
100mg 1x/d
Other Names:
  • Aspirin cardio
Drug: Clopidogrel
75mg 1x/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within one year after index stroke

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
within one year after index stroke
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)
within one year after index stroke

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Collaborators

Swiss National Science Foundation

Investigators

  • Principal Investigator: Mira Katan, Prof.Dr.med., University Hospital, Basel, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2019

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 21, 2019

First Posted (Actual)

May 23, 2019

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 11, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOSES

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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