Mid-regional pro-atrial natriuretic peptide as a guide for secondary stroke prevention: The MOSES study
Summary description of the study
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 under investigation
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)
Disease under 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)
Exclusion criteria
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)
Trial sites
Aarau, Basel, Bern, Lugano, St. Gallen, Winterthur, Zurich
(BASEC)
Sponsor
Prof. Dr. med. Mira Katan
(BASEC)
Contact
Contact Person Switzerland
Prof. Dr. med. Mira Katan
+41 61 328 45 06
mira.katan@clutterusb.chUniversity Hospital Zurich
(BASEC)
General Information
University Hospital, Basel, Switzerland,
+41 61 328 45 06
mira.katan@clutterusb.ch(ICTRP)
Scientific Information
University Hospital, Basel, Switzerland,
+41 61 328 45 06
mira.katan@clutterusb.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
13.11.2019
(BASEC)
ICTRP Trial ID
NCT03961334 (ICTRP)
Official title (approved by ethics committee)
MidregiOnal proatrial natriuretic peptide to guide SEcondary Stroke prevention: The MOSES-study An international, multicentre, randomised-controlled, two-arm, assessor-blinded trial (BASEC)
Academic title
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial (ICTRP)
Public title
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention (ICTRP)
Disease under investigation
Stroke, Ischemic (ICTRP)
Intervention under investigation
Drug: Dabigatran;Drug: Apixaban;Drug: Edoxaban;Drug: Aspirin;Drug: Clopidogrel (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). (ICTRP)
Inclusion/Exclusion criteria
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)
not available
Primary and secondary end points
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)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
Swiss National Science Foundation (ICTRP)
Additional contacts
Mira Katan, Prof.Dr.med.;Mira Katan, Prof.Dr.med., mira.katan@usb.ch, +41 61 328 45 06, University Hospital, Basel, Switzerland, (ICTRP)
Secondary trial IDs
MOSES (ICTRP)
Results-Individual Participant Data (IPD)
No (ICTRP)
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT03961334 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available