Multicentre (national, Germany), randomized (2x2 factorial), open, parallel group, active controlled, efficacy study (phase III)
Based on the previous data, ATTICUS is designed as multicentre, national, parallel group, active controlled, phase III randomized (2x2 factorial), clinical trial to demonstrate the superiority of apixaban against the current standard of treatment (acetylsalicylic acid) for the longterm treatment after ESUS. ATTICUS will follow a dynamic treatment protocol implementing conversion from the acetylsalicylic acid arm to the apixaban arm in case of detection of relevant episodes of AF during the course of the study. ATTICUS is designed to test the superiority over acetylsalicylic acid to reduce new ischemic lesion detected by FLAIR/DWI MRI.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
352
Apixaban is an oral anticoagulant currently approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, for the treatment of deep vein thrombosis and pulmonary embolism, and for the prophylaxis of systemic embolism after orthopedic surgery
Acetylic Salicylic Acid 100mg o.d.; 12 Months
MedicalPark Berlin Humboldtmühle GmbH & Co. KG
Berlin, Germany
Neurologische Klinik, Universität Bonn
Bonn, Germany
Imaging Endpoint: Occurrence of at least one new ischemic lesion at 12 months after study drug initiation when compared to baseline MRI before study drug initiation
The primary endpoint will be the occurrence of at least one new ischemic lesion identified by magnetic resonance imaging (axial T2-weighted fluid attenuated inversion recovery MRI (FLAIR) and/or axial diffusion weighted MRI (DWI)) at 12 months when compared to the baseline MRI (FLAIR, DWI) obtained at the time of study drug initiation. MRI at 12 months will be directly compared with the baseline MRI to assess for new ischemic lesions.
Time frame: 12 months
Combination of recurrent ischaemic stroke, hemorrhagic stroke, systemic embolism
The occurence of ischaemic stroke, hemorrhagic stroke, or systemic embolism during study participation (12months) will be quantified
Time frame: 12 months
Combination of major adverse cardiovascular events (MACE) including recurrent stroke, myocardial infarction and cardiovascular death
The occurence of major adverse cardiovascular events (MACE) including recurrent stroke, myocardial infarction and cardiovascular death during study participation (12months) will be quantified
Time frame: 12 months
Combination of major and clinically relevant non-major bleedings defined according to ISTH criteria
The occurence of major and clinically relevant non-major bleedings defined according to ISTH criteria during study participation (12months) will be quantified
Time frame: 12 months
Change of cognitive function (MOCA)
MOCA test will be performed upon study enrollment and 12 months after enrollment and both tests will be compared
Time frame: 12 months
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Regiomed Kliniken Coburg GmbH Abt. II
Coburg, Germany
Neurologie, Klinikum Friedrichshafen GmbH
Friedrichshafen, Germany
Universitätsmedizin Göttingen Abt.Innere Medizin, Klinik für Kardiologie und Pneumologie,
Göttingen, Germany
Krankenhaus Martha-Maria Halle-Döhlau
Halle, Germany
Klinik für Neurolgie,UKSH Campus Kiel
Kiel, Germany
Klinik für Neurologie, Klinikum Ludwigsburg
Ludwigsburg, Germany
Universitätsklinik für Neurologie, Magdeburg
Magdeburg, Germany
Carl von Basedow KlinikumSaalekreis gGmbH
Merseburg, Germany
...and 6 more locations
Life quality (EQ-5D)
EQ-5D questionnaire will be raised upon study enrollment and 12 months after enrollment and both questionnaires will be compared
Time frame: 12 months