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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03961334
Recruitment Status : Recruiting
First Posted : May 23, 2019
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Mira Katan, University of Zurich

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) versus antiplatelets as preventive treatment.

Condition or disease Intervention/treatment Phase
Stroke, Ischemic Drug: Rivaroxaban Drug: Dabigatran Drug: Apixaban Drug: Edoxaban Drug: Aspirin Drug: Clopidogrel Phase 3

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 control (antiplatelet) or the experimental (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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 590 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial
Actual Study Start Date : December 5, 2019
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Arm Intervention/treatment
Experimental: DOACs
Direct oral anticoagulants
Drug: Rivaroxaban
20mg 1x/d
Other Name: Xarelto

Drug: Dabigatran
150mg 2x/d
Other Name: Pradaxa

Drug: Apixaban
5mg 2x/d
Other Name: Eliquis

Drug: Edoxaban
60mg 1x/d
Other Name: Lixiana

Active Comparator: Antiplatelets
Antiplatelets
Drug: Aspirin
100mg 1x/d
Other Name: Aspirin cardio

Drug: Clopidogrel
75mg 1x/d




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03961334


Contacts
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Contact: Mira Katan, PD Dr. med. +41 44 255 47 32 mira.katan@usz.ch

Locations
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Germany
Universitätsklinikum Hamburg-Eppendorf Not yet recruiting
Hamburg, Germany, 20246
Contact: Götz Thomalla, MD       thomalla@uke.de   
Principal Investigator: Götz Thomalla, Prof.Dr.med.         
Norway
Oslo University Hospital - Ullevål Not yet recruiting
Oslo, Norway, 0424
Contact: Else Charlotte Sandset, Dr. med.       else@sandset.net   
Principal Investigator: Else Charlotte Sandset, Dr. med.         
Spain
Hospital de la Santa Creu I Sant Pau Not yet recruiting
Barcelona, Spain, 08041
Contact: Joan Montaner, MD       jmontaner-ibis@us.es   
Principal Investigator: Joan Montaner, Prof.Dr.med.         
Hospital Universitario Virgen Macarena Not yet recruiting
Sevilla, Spain, 41009
Contact: Joan Montaner, MD       jmontaner-ibis@us.es   
Principal Investigator: Joan Montaner, Prof. Dr. med.         
Campus Hospital Universitario Virgen del Rocío Not yet recruiting
Sevilla, Spain, 41013
Contact: Joan Montaner, MD       jmontaner-ibis@us.es   
Principal Investigator: Joan Montaner, Prof.Dr.med.         
Switzerland
Kantonsspital Aarau, Department of Neurology Recruiting
Aarau, Argau, Switzerland, 5001
Contact: Timo Kahles, MD       timo.kahles@ksa.ch   
Principal Investigator: Timo Kahles, Dr. med.         
University Hospital of Basel Recruiting
Basel, Switzerland, 4031
Contact: Gian Marco De Marchis, MD       gian.demarchis@usb.ch   
Principal Investigator: Gian Marco De Marchis, PD Dr. med.         
University Hospital of Bern/Inselspital Recruiting
Bern, Switzerland, 3010
Contact: Urs Fischer, MD       urs.fischer@insel.ch   
Principal Investigator: Urs Fischer, Prof.Dr.med.         
Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale Active, not recruiting
Lugano, Switzerland, 6900
Kantonsspital St.Gallen Active, not recruiting
St.Gallen, Switzerland, 9007
University Hospital of Zurich, Department of Neurology Recruiting
Zurich, Switzerland, 8091
Contact: Mira Katan, PD Dr. med.       mira.katan@usz.ch   
Principal Investigator: Mira Katan, PD Dr. med.         
United Kingdom
Queen Elizabeth University Hospital Not yet recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Jesse Dawson, MD       jesse.dawson@glasgow.ac.uk   
Principal Investigator: Jesse Dawson, Prof.Dr.med.         
Sponsors and Collaborators
University of Zurich
Investigators
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Principal Investigator: Mira Katan, PD Dr. med. University of Zurich
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Responsible Party: Mira Katan, PD Dr. med., University of Zurich
ClinicalTrials.gov Identifier: NCT03961334    
Other Study ID Numbers: MOSES
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Aspirin
Rivaroxaban
Apixaban
Edoxaban
Dabigatran
Clopidogrel
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists