MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

NCT03961334 | Unknown Phase 3 DMC

• 1 other identifier: MOSES
• Study Type: interventional
• Target: 620
• Locations: 5 countries
• Sites: 14

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) within 7 days of symptom onset versus standard of care (antiplatelet) as preventive treatment.

Conditions

Stroke, Ischemic

Outcome Measures

Primary Outcomes (1)

• Recurrent stroke of any type

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

  within one year after index stroke

Secondary Outcomes (2)

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

  within one year after index stroke

• Major bleeding, recurrent stroke and/or vascular death as single components

  within one year after index stroke

Study Arms (2)

DOACs

EXPERIMENTAL

Direct oral anticoagulants

Drug: Dabigatran; Drug: Apixaban; Drug: Edoxaban

Antiplatelets

ACTIVE COMPARATOR

SOC therapy with antiplatelets until study completion or until detection of AF. After detection of AF treatment with DOAC becomes SOC.

Drug: Aspirin; Drug: Clopidogrel

Interventions

Dabigatran DRUG

150mg 2x/d

Also known as: Pradaxa

DOACs

Apixaban DRUG

5mg 2x/d

Also known as: Eliquis

DOACs

Edoxaban DRUG

60mg 1x/d

Also known as: Lixiana

DOACs

Aspirin DRUG

100mg 1x/d

Also known as: Aspirin cardio

Antiplatelets

Clopidogrel DRUG

75mg 1x/d

Antiplatelets

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• Swiss National Science Foundation: collaborator

Study Sites (14)

Attikon University Hospital

Athens, 12462, Greece

RECRUITING

Oslo University Hospital - Ullevål

Oslo, 0424, Norway

NOT YET RECRUITING

Hospital de la Santa Creu I Sant Pau

Barcelona, 08041, Spain

RECRUITING

Hospital Universitario Virgen Macarena

Seville, 41009, Spain

RECRUITING

Campus Hospital Universitario Virgen del Rocío

Seville, 41013, Spain

RECRUITING

Kantonsspital Aarau, Department of Neurology

Aarau, Canton of Aargau, 5001, Switzerland

RECRUITING

University Hospital of Basel

Basel, 4031, Switzerland

RECRUITING

University Hospital of Bern/Inselspital

Bern, 3010, Switzerland

RECRUITING

Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale

Lugano, 6900, Switzerland

RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, 9007, Switzerland

RECRUITING

Kantonsspital Winterthur

Winterthur, 8401, Switzerland

NOT YET RECRUITING

Klinik Hirslanden

Zurich, 8032, Switzerland

NOT YET RECRUITING

University Hospital of Zurich, Department of Neurology

Zurich, 8091, Switzerland

RECRUITING

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Ischemic Stroke

Interventions

Dabigatran; apixaban; edoxaban; Aspirin; Clopidogrel

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Ticlopidine; Thienopyridines; Thiophenes; Sulfur Compounds

Study Officials

• Mira Katan, Prof.Dr.med.

  University Hospital, Basel, Switzerland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mira Katan, Prof.Dr.med.

CONTACT

+41 61 328 45 06; mira.katan@usb.ch

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinded endpoint assessment by independent CEC
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: May 23, 2019
• Study Start: December 5, 2019
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2026
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3); CH (8); GR (1); GB (1); NO (1)