Patients with ischemic stroke and elevated midregional proatrial natriuretic peptide (MRproANP) levels without known atrial fibrillation.
Conditions
Interventions
Trade Name: Eliquis
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Apixaban
Other descriptive name: APIXABAN
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration n
Sponsors
PD Dr. med. Mira Katan
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Clinical diagnosis of acute ischemic stroke -MRproANP level above 200pmol/L within 72 hours from symptom onset -Age = 18 years -Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 295 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 295
Exclusion criteria
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 therapeutic dose of low-molecular-weight heparin or heparin -Strong likelihood to be treated with prolonged (i.e. more than 90 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. acute surgery) -Previous intracranial symptomatic hemorrhage in the last 24 months -Evidence of severe cerebral amyloid angiopathy if MRI scan performed -Chronic kidney disease with creatinine 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 < 8 g/dl or INR = 1.7, documented haemorrhagic tendencies or blood dyscrasias) -Active infective endocarditis -Known allergy or intolerance to antiplatelets or DOACs -Female who is pregnant or lactating or has a positive pregnancy test at time of admission -If restricted by national law: Current participation in another drug trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study seeks primarily to determine the effect of DOACs on reducing rates of recurrent stroke of any type compared to antiplatelet therapy within one year after index ischemic stroke in patients who have MRproANP levels > 200pmol/L and no known atrial fibrillation (AF) at randomization;Secondary Objective: The study seeks secondarily to determine the effect of DOACs on reducing rates of the composite of major bleeding, recurrent stroke of any type, and/or vascular death compared to antiplatelet therapy within one year after index ischemic stroke in MRproANP selected patients without known atrial fibrillation.;Primary end point(s): The primary outcome measure is the time to any recurrent stroke within 1 year after the index ischemic stroke.;Timepoint(s) of evaluation of this end point: One year after the index ischemic stroke | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Composite of major bleeding, recurrent stroke and/or vascular death (whichever occurs first) within 1 year after the index ischemic stroke -Single components of the composite outcome above;Timepoint(s) of evaluation of this end point: One year after the index ischemic stroke | — |
Countries
Germany, Greece, Norway, Spain, Switzerland, United Kingdom
Contacts
Public ContactSponsor-Investigator
PD Dr. med. Mira Katan
Outcome results
None listed