MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

Last updated: August 11, 2023
Sponsor: University of Zurich
Overall Status: Active - Recruiting

Phase

3

Condition

Cerebral Ischemia

Stroke

Thrombosis

Treatment

Apixaban

Dabigatran

Aspirin

Clinical Study ID

NCT03961334
MOSES
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

  • History of AF, AF on 12-lead ECG on admission or any AF ≥30 seconds duringheart-rhythm monitoring prior to randomization
  • Other condition that require anticoagulant therapy (e.g., venous thromboembolism) asper Investigator's judgment including therapeutical dose of low-molecular-weightheparin or heparin
  • Strong likelihood to be treated with prolonged (i.e. more than 30 days) dualantiplatelet 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 requireshaemodialysis 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 tendenciesor 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 ofadmission
  • Current participation in another drug trial

Study Design

Total Participants: 620
Treatment Group(s): 5
Primary Treatment: Apixaban
Phase: 3
Study Start date:
December 05, 2019
Estimated Completion Date:
January 31, 2026

Study 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.

Connect with a study center

  • Charité - Universitätsmedizin Berlin

    Berlin, 10117
    Germany

    Site Not Available

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246
    Germany

    Site Not Available

  • Attikon University Hospital

    Athens, 12462
    Greece

    Active - Recruiting

  • Larissa University Hospital of Thessaly

    Larissa, 41110
    Greece

    Site Not Available

  • Oslo University Hospital - Ullevål

    Oslo, 0424
    Norway

    Site Not Available

  • Hospital de la Santa Creu I Sant Pau

    Barcelona, 08041
    Spain

    Active - Recruiting

  • Campus Hospital Universitario Virgen del Rocío

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario Virgen Macarena

    Sevilla, 41009
    Spain

    Active - Recruiting

  • Kantonsspital Aarau, Department of Neurology

    Aarau, Argau 5001
    Switzerland

    Active - Recruiting

  • University Hospital of Basel

    Basel, 4031
    Switzerland

    Active - Recruiting

  • University Hospital of Bern/Inselspital

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Hôpitaux Universitaires Genève

    Geneva, 1211
    Switzerland

    Site Not Available

  • Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale

    Lugano, 6900
    Switzerland

    Active - Recruiting

  • Kantonsspital St.Gallen

    St.Gallen, 9007
    Switzerland

    Active - Recruiting

  • Kantonsspital Winterthur

    Winterthur, 8401
    Switzerland

    Site Not Available

  • University Hospital of Zurich, Department of Neurology

    Zurich, 8091
    Switzerland

    Active - Recruiting

  • Klinik Hirslanden

    Zürich, 8032
    Switzerland

    Site Not Available

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF
    United Kingdom

    Site Not Available

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