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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
620

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Zurich

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss National Science Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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