Using a specific blood marker to guide stroke prevention treatment
MidregiOnal Proatrial Natriuretic Peptide to Guide SEcondary Stroke Prevention: The MOSES-study. An International, Multicentre, Randomised-controlled, Two-arm, Assessor-blinded Trial
This study tests if stroke patients with a certain blood marker do better with a new blood thinner compared to the usual treatment to prevent another stroke.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 620 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 14 sites (Athens and 13 other locations) |
| Trial ID | NCT03961334 on ClinicalTrials.gov |
What this trial studies
This trial investigates whether ischemic stroke patients, identified by elevated levels of MRproANP, benefit from direct oral anticoagulation (DOAC) compared to standard antiplatelet therapy. Patients without known atrial fibrillation will be randomly assigned to receive either DOACs or standard care within 7 days of symptom onset. The study will follow participants for one year to assess outcomes related to secondary stroke prevention.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have experienced an ischemic stroke and have MRproANP levels of 200pmol/L or higher.
Not a fit: Patients with a history of atrial fibrillation or those requiring anticoagulant therapy for other conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective prevention of secondary strokes in a specific subgroup of patients.
How similar studies have performed: While the use of DOACs for stroke prevention is established, this specific approach targeting a distinct patient subgroup is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Athens and 13 other locations
- Attikon University Hospital — Athens, Greece (Recruiting)
- Oslo University Hospital - Ullevål — Oslo, Norway (Not_yet_recruiting)
- Hospital de la Santa Creu I Sant Pau — Barcelona, Spain (Recruiting)
- Hospital Universitario Virgen Macarena — Sevilla, Spain (Recruiting)
- Campus Hospital Universitario Virgen del Rocío — Sevilla, Spain (Recruiting)
- Kantonsspital Aarau, Department of Neurology — Aarau, Argau, Switzerland (Recruiting)
- University Hospital of Basel — Basel, Switzerland (Recruiting)
- University Hospital of Bern/Inselspital — Bern, Switzerland (Recruiting)
- Ospedale Regionale di Lugano, Ente Ospedaliero Cantonale — Lugano, Switzerland (Recruiting)
- Kantonsspital St.Gallen — St.Gallen, Switzerland (Recruiting)
- Kantonsspital Winterthur — Winterthur, Switzerland (Not_yet_recruiting)
- University Hospital of Zurich, Department of Neurology — Zurich, Switzerland (Recruiting)
- Klinik Hirslanden — Zürich, Switzerland (Not_yet_recruiting)
- Queen Elizabeth University Hospital — Glasgow, United Kingdom (Not_yet_recruiting)
Study contacts
- Principal investigator: Mira Katan, Prof.Dr.med. — University Hospital, Basel, Switzerland
- Study coordinator: Mira Katan, Prof.Dr.med.
- Email: mira.katan@usb.ch
- Phone: +41 61 328 45 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.