Mid-regional pro-atrial natriuretic peptide as a guide for secondary stroke prevention: The MOSES study
Résumé de l'étude
To prevent further strokes, two groups of medications are used: antiplatelets or anticoagulants. So far, all patients without underlying cardiac disease, such as an irregular heart rhythm (atrial fibrillation), receive antiplatelets as standard therapy. In contrast, for patients with atrial fibrillation, anticoagulants are more effective for stroke prevention. We aim to investigate in this study whether, in stroke patients where a blood value (MRproANP) indicates a high suspicion of underlying cardiac disease, anticoagulants are more effective compared to the usual standard therapy in preventing further strokes.
(BASEC)
Intervention étudiée
Patients are randomly assigned either to the group with standard treatment with antiplatelets (such as Aspirin® or Clopidogrel®) or to the group with anticoagulants, known as direct oral anticoagulants. The following direct oral anticoagulants, already approved in Switzerland and the European Union for stroke prevention, may be used in this study at usual dosages: Dabigatran (Pradaxa®), Apixaban (Eliquis®), and Edoxaban (Lixiana®). In both groups, the patient receives the recommended dosage of the respective medication for stroke prevention according to the package insert/professional information. The study participation lasts one year.
(BASEC)
Maladie en cours d'investigation
Acute ischemic stroke in patients without known atrial fibrillation
(BASEC)
Patients may participate in the study if they are over 18 years old, have suffered a stroke due to insufficient blood flow to the brain (ischemic stroke), and have an increased risk of underlying cardiac disease based on a blood value (MRproANP). (BASEC)
Critères d'exclusion
Patients may not participate if they have renal failure, have had intracranial bleeding in the last 24 months, or present a high bleeding risk, as well as having known atrial fibrillation. (BASEC)
Lieu de l’étude
Aarau, Bâle, Berne, Lugano, St-Gall, Winterthur, Zurich
(BASEC)
Sponsor
Prof. Dr. med. Mira Katan
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Dr. med. Mira Katan
+41 61 328 45 06
mira.katan@clutterusb.chUniversity Hospital Zurich
(BASEC)
Informations générales
University Hospital, Basel, Switzerland,
+41 61 328 45 06
mira.katan@clutterusb.ch(ICTRP)
Informations scientifiques
University Hospital, Basel, Switzerland,
+41 61 328 45 06
mira.katan@clutterusb.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
13.11.2019
(BASEC)
Identifiant de l'essai ICTRP
NCT03961334 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
MidregiOnal proatrial natriuretic peptide to guide SEcondary Stroke prevention: The MOSES-study An international, multicentre, randomised-controlled, two-arm, assessor-blinded trial (BASEC)
Titre académique
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial (ICTRP)
Titre public
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention (ICTRP)
Maladie en cours d'investigation
Stroke, Ischemic (ICTRP)
Intervention étudiée
Drug: Dabigatran;Drug: Apixaban;Drug: Edoxaban;Drug: Aspirin;Drug: Clopidogrel (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
Gender: All
Maximum age: N/A
Minimum age: 18 Years
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
(ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Recurrent stroke of any type (ICTRP)
Composite of major bleeding, recurrent stroke and/or vascular death;Major bleeding, recurrent stroke and/or vascular death as single components (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
Swiss National Science Foundation (ICTRP)
Contacts supplémentaires
Mira Katan, Prof.Dr.med.;Mira Katan, Prof.Dr.med., mira.katan@usb.ch, +41 61 328 45 06, University Hospital, Basel, Switzerland, (ICTRP)
ID secondaires
MOSES (ICTRP)
Résultats-Données individuelles des participants
No (ICTRP)
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT03961334 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible