MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention

NCT ID: NCT03961334

Last Updated: 2023-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

620 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-05

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Stroke, Ischemic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Blinded endpoint assessment by independent CEC

Study Groups

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DOACs

Direct oral anticoagulants

Group Type EXPERIMENTAL

Dabigatran

Intervention Type DRUG

150mg 2x/d

Apixaban

Intervention Type DRUG

5mg 2x/d

Edoxaban

Intervention Type DRUG

60mg 1x/d

Antiplatelets

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

Group Type ACTIVE_COMPARATOR

Aspirin

Intervention Type DRUG

100mg 1x/d

Clopidogrel

Intervention Type DRUG

75mg 1x/d

Interventions

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Dabigatran

150mg 2x/d

Intervention Type DRUG

Apixaban

5mg 2x/d

Intervention Type DRUG

Edoxaban

60mg 1x/d

Intervention Type DRUG

Aspirin

100mg 1x/d

Intervention Type DRUG

Clopidogrel

75mg 1x/d

Intervention Type DRUG

Other Intervention Names

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Pradaxa Eliquis Lixiana Aspirin cardio

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Swiss National Science Foundation

OTHER

Sponsor Role collaborator

University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Mira Katan

Prof. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mira Katan, Prof.Dr.med.

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Basel, Switzerland

Locations

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Attikon University Hospital

Athens, , Greece

Site Status RECRUITING

Oslo University Hospital - Ullevål

Oslo, , Norway

Site Status NOT_YET_RECRUITING

Hospital de la Santa Creu I Sant Pau

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Campus Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status RECRUITING

Kantonsspital Aarau, Department of Neurology

Aarau, Canton of Aargau, Switzerland

Site Status RECRUITING

University Hospital of Basel

Basel, , Switzerland

Site Status RECRUITING

University Hospital of Bern/Inselspital

Bern, , Switzerland

Site Status RECRUITING

Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale

Lugano, , Switzerland

Site Status RECRUITING

Kantonsspital St.Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

Kantonsspital Winterthur

Winterthur, , Switzerland

Site Status NOT_YET_RECRUITING

Klinik Hirslanden

Zurich, , Switzerland

Site Status NOT_YET_RECRUITING

University Hospital of Zurich, Department of Neurology

Zurich, , Switzerland

Site Status RECRUITING

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Greece Norway Spain Switzerland United Kingdom

Central Contacts

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Mira Katan, Prof.Dr.med.

Role: CONTACT

+41 61 328 45 06

Facility Contacts

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Georgios Tsivgoulis, Prof.Dr.med.

Role: primary

Else Charlotte Sandset, Dr. med.

Role: primary

Joan Montaner, MD

Role: primary

Joan Montaner, MD

Role: primary

Joan Montaner, MD

Role: primary

Timo Kahles, MD

Role: primary

Mira Katan, Prof.Dr.med.

Role: primary

David Seiffge, PD Dr. med.

Role: primary

Carlo Cereda, MD

Role: primary

Georg Kägi, MD

Role: primary

Biljana Rodic-Tatic, Dr. med.

Role: primary

Nils Peters, Prof.Dr.med.

Role: primary

Susanne Wegener, Prof.Dr.med.

Role: primary

Jesse Dawson, MD

Role: primary

Other Identifiers

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MOSES

Identifier Type: -

Identifier Source: org_study_id

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