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Stroke, IschemicPhase 3MOSESNCT03961334

MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

A Phase 3 study testing Dabigatran, Apixaban and Edoxaban in people with Stroke, Ischemic, run by University of Zurich at 14 sites in 5 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Stroke, Ischemic
What is being tested?
Dabigatran, Apixaban and Edoxaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
620 participants
Where
14 sitesin 5 countries
Study dates
5 Dec 2019to 31 Jan 2026
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Clinical diagnosis of ischemic stroke
  • level ≥200pmol/L within 72 hours from symptom onset
  • Age ≥ 18 years
  • Signed informed consent

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

14 sites in 5 countries.

Mira Katan, Prof.Dr.med. contact

+41 61 328 45 06

mira.katan@usb.ch

14 sites in 5 countries

Switzerland8 sites, 8 recruiting

  • Kantonsspital Aarau, Department of Neurology

    Aarau, Canton of Aargau, 5001

    Timo Kahles, MD, timo.kahles@ksa.ch

    Timo Kahles, Dr. med.

    Recruiting

  • University Hospital of Basel

    Basel, 4031

    Mira Katan, Prof.Dr.med., Mira.katan@usb.ch

    Mira Katan, Prof.Dr.med.

    Recruiting

  • University Hospital of Bern/Inselspital

    Bern, 3010

    David Seiffge, PD Dr. med., david.seiffge@insel.ch

    David Seiffge, PD Dr. med.

    Recruiting

  • Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale

    Lugano, 6900

    Carlo Cereda, MD, carlo.cereda@eoc.ch

    Carlo Cereda, PD Dr. med.

    Recruiting

  • Kantonsspital St.Gallen

    Sankt Gallen, 9007

    Georg Kägi, MD, georg.kaegi@kssg.ch

    Georg Kägi, PD Dr. med.

    Recruiting

  • Kantonsspital Winterthur

    Winterthur, 8401

    Biljana Rodic-Tatic, Dr. med., biljana.rodic@ksw.ch

    Biljana Rodic-Tatic, Dr. med.

    Not yet recruiting

  • Klinik Hirslanden

    Zurich, 8032

    Nils Peters, Prof.Dr.med., nils.peters@hirslanden.ch

    Nils Peters, Prof.Dr.med.

    Not yet recruiting

  • University Hospital of Zurich, Department of Neurology

    Zurich, 8091

    Susanne Wegener, Prof.Dr.med., susanne.wegener@usz.ch

    Susanne Wegener, Prof.Dr.med.

    Recruiting

Other trials in Switzerland

Spain3 sites, 3 recruiting

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08041

    Joan Montaner, MD, jmontaner-ibis@us.es

    Joan Montaner, Prof.Dr.med.

    Recruiting

  • Hospital Universitario Virgen Macarena

    Seville, 41009

    Joan Montaner, MD, jmontaner-ibis@us.es

    Joan Montaner, Prof.Dr.med.

    Recruiting

  • Campus Hospital Universitario Virgen del Rocío

    Seville, 41013

    Joan Montaner, MD, jmontaner-ibis@us.es

    Joan Montaner, Prof.Dr.med.

    Recruiting

Other trials in Spain

Greece1 site, 1 recruiting

  • Attikon University Hospital

    Athens, 12462

    Georgios Tsivgoulis, Prof.Dr.med., gtsivou@med.uoa.gr

    Georgios Tsivgoulis, Prof.Dr.med.

    Recruiting

Other trials in Greece

Norway1 site, 1 recruiting

  • Oslo University Hospital - Ullevål

    Oslo, 0424

    Else Charlotte Sandset, Dr. med., else@sandset.net

    Else Charlotte Sandset, Dr. med.

    Not yet recruiting

Other trials in Norway

United Kingdom1 site, 1 recruiting

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

    Jesse Dawson, MD, jesse.dawson@glasgow.ac.uk

    Jesse Dawson, Prof.Dr.med.

    Not yet recruiting

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
Dabigatran, Apixaban, Edoxaban, Aspirin, Clopidogrel
Medical subject headings
Ischemic Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DabigatranDrug

    Also called Pradaxa

    150mg 2x/d

  • ApixabanDrug

    Also called Eliquis

    5mg 2x/d

  • EdoxabanDrug

    Also called Lixiana

    60mg 1x/d

  • AspirinDrug

    Also called Aspirin cardio

    100mg 1x/d

  • ClopidogrelDrug

    75mg 1x/d

Study groups in NCT03961334
Study groupRoleWhat they receive
DOACsExperimentalDirect oral anticoagulants
Receives: Drug: Dabigatran; Drug: Apixaban; Drug: Edoxaban
AntiplateletsActive comparatorSOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.
Receives: Drug: Aspirin; Drug: Clopidogrel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recurrent stroke of any type

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

    Measured: within one year after index stroke

Secondary outcomes (2)

  1. Composite of major bleeding, recurrent stroke and/or vascular death

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

    Measured: within one year after index stroke

  2. 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)

    Measured: within one year after index stroke

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 May 2019
  2. Study start5 Dec 2019
  3. Primary completion31 Jan 2025 (estimated)
  4. Study completion31 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
620 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03961334
Sponsor's protocol ID
MOSES
Acronym
MOSES
Status last verified
Aug 2023
First submitted
16 May 2019
Last updated
16 Aug 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Dabigatran, Apixaban and Edoxaban in people with Stroke, Ischemic, run by University of Zurich at 14 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Switzerland, Spain, Greece, Norway, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mira Katan, Prof.Dr.med. (+41 61 328 45 06, mira.katan@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recurrent stroke of any type (time frame: within one year after index stroke). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03961334.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2023.

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