Stroke, Ischemic
Conditions
Brief summary
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
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.
Interventions
DRUGDabigatran
150mg 2x/d
DRUGApixaban
5mg 2x/d
DRUGEdoxaban
60mg 1x/d
DRUGAspirin
100mg 1x/d
DRUGClopidogrel
75mg 1x/d
Sponsors
Swiss National Science Foundation
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
Blinded endpoint assessment by independent CEC
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent stroke of any type | within one year after index stroke | The primary outcome measure is the time to any recurrent stroke (ischemic, hemorrhagic, unspecified, or fatal stroke) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composite of major bleeding, recurrent stroke and/or vascular death | within one year after index stroke | Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first) |
| Major bleeding, recurrent stroke and/or vascular death as single components | within one year after index stroke | Each single component of the composite in outcome 2 (major bleeding, recurrent stroke and/or vascular death) |
Countries
Greece, Norway, Spain, Switzerland, United Kingdom
Contacts
Primary ContactMira Katan, Prof.Dr.med.
Outcome results
None listed