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

University of Zurich (UZH)

Status and phase: Enrolling; Phase 3

Conditions: Stroke, Ischemic

Treatments: Drug: Apixaban; Drug: Dabigatran; Drug: Edoxaban; Drug: Aspirin; Drug: Clopidogrel

Study type: Interventional

Funder types: Other

Identifiers

NCT03961334

MOSES

Details and patient eligibility

About

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.

Full 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.

Enrollment: 620 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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620 participants in 2 patient groups

DOACs

Experimental group

Description:

Direct oral anticoagulants

Treatment:

Drug: Edoxaban

Drug: Dabigatran

Drug: Apixaban

Antiplatelets

Active Comparator group

Description:

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

Treatment:

Drug: Clopidogrel

Drug: Aspirin