Rivaroxaban Plus ASA in Embolic Stroke of Undetermined Source(AREST-ESUS) (NCT04273516) | Clinical Trial Compass
CompletedPhase 2/3
Rivaroxaban Plus ASA in Embolic Stroke of Undetermined Source(AREST-ESUS)
Iran42 participantsStarted 2020-08-22
Plain-language summary
Approximately 17% of all patients with stroke are classified as having ESUS, which is associated with a considerable rate of stroke recurrence 4-5 % per year.
Despite recent scientific advances in acute ischemic stroke treatment in recent decades,consensus treatment of all guidelines is still ASA
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. signing the inform consent
✓. recent ischemic stroke ( 7-60) days with criteria of ESUS
✓. only one risk factors of potential embolic source including:
✓. PTFV1 in standard ECG ≥0.05 mm.s or ≥0.005 mv.s
✓. LVH in standard ECG( Sokolow index≥ 35 mm) or on echocardiography
✓. Moderate or severe valvular disorder on echocardiography (except MS)
✓. PFO without indication of occlusion
✓. Left atrium enlargement in echocardiography
Exclusion criteria
✕. History of hypersensitivity to the investigational medicinal product
✕. Indication for anticoagulation
✕. Indication for dual antiplatelet therapy
✕. Contraindication to investigational medications
✕. History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
✕. Gastrointestinal bleed or major surgery within 3 months
✕
What they're measuring
1
Rate of stroke recurrence
Timeframe: Rate of stroke recurrence during one year fallow up