Mid-regional pro-atrial natriuretic peptide as a guide for secondary stroke prevention: The MOSES study
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Aarau, Basilea, Berna, Lugano, San Gallo, Winterthur, Zurigo
(BASEC)
Sponsor
Prof. Dr. med. Mira Katan
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Prof. Dr. med. Mira Katan
+41 61 328 45 06
mira.katan@clutterusb.chUniversity Hospital Zurich
(BASEC)
Informazioni generali
University Hospital, Basel, Switzerland,
+41 61 328 45 06
mira.katan@clutterusb.ch(ICTRP)
Informazioni scientifiche
University Hospital, Basel, Switzerland,
+41 61 328 45 06
mira.katan@clutterusb.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
13.11.2019
(BASEC)
ID di studio ICTRP
NCT03961334 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
MidregiOnal proatrial natriuretic peptide to guide SEcondary Stroke prevention: The MOSES-study An international, multicentre, randomised-controlled, two-arm, assessor-blinded trial (BASEC)
Titolo accademico
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial (ICTRP)
Titolo pubblico
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention (ICTRP)
Malattie studiate
Stroke, Ischemic (ICTRP)
Intervento studiato
Drug: Dabigatran;Drug: Apixaban;Drug: Edoxaban;Drug: Aspirin;Drug: Clopidogrel (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Criteri di inclusione/esclusione
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 disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Swiss National Science Foundation (ICTRP)
Contatti aggiuntivi
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 secondari
MOSES (ICTRP)
Risultati-Dati individuali dei partecipanti
No (ICTRP)
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT03961334 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile