Apixaban for Treatment of Embolic Stroke of Undetermined Source "ATTICUS"


Phase 3 Results N/A

Eligibility Criteria

Inclusion criteria Must be ≥ 18 years at the time of signing the informed consent.
- ESUS must be defined according to following criteria:
- Stroke detected by CT or MRI that is not lacunar
- Absence of extracranial or intracranial atherosclerosis causing ≥50% luminal stenosis in arteries supplying the area of ischaemia
- No major-risk cardioembolic source of embolism
- No other specific cause of stroke identified
- * At least one of the following non-major but suggestive risk factors for cardiac embolism:
- LA size >45mm (parasternal axis)
- spontaneous echo contrast in LAA
- LAA flow velocity <=0.2m/s
- atrial high rate episodes
- CHA2DS2-Vasc score >=4
- persistent foramen ovale
- Understand and voluntarily sign an informed consent document
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception.

Exclusion Criteria

- History of hypersensitivity to the investigational medicinal product
- Participation in other clinical trials or observation period of competing trials.
- Arteria cerebri media stroke affecting > 30% of c o r r e s p o n d i n g territory
- Diagnosis of haemorrhage or other pathology,
- Clear indication for anticoagulation
- Inability to control following risk factors for Hemorrhagic Transformation of fresh cerebral Infarction (HTI) during index hospital stay: presence of HTI at the time of anticoagulation, blood pressure >140 mmHg systolic, abnormal blood glucose Clear indication for dual antiplatelet therapy
- Clear stroke-/non-stroke-indication for concomitant long-term therapy with antiplatelets (e.g. acetylsalicylic acid (ASA), Clopidogrel, or Prasugrel) or with non-steroidal anti-inflammatory drugs (NSAID).
- Concomitant systemic therapy with strong inhibitors of cytochrome P450 3A4 (CYP3A4) and P-glycoprotein (P-gp), i.e. azoleantimycotics and human immunodeficiency virus (HIV)-protease inhibitors.
- Contraindication to investigational medications
- Planned or likely therapy with fibrinolytic agents within 48 hours of first study medication
- History of intracranial, intraocular, spinal, retroperitoneal or atraumatic intra-articular bleeding
- Gastrointestinal bleed or major surgery within 3 months
- Planned or likely revascularization (any angioplasty or vascular surgery) within the next 3 months
- TIA or minor stroke induced by angiography or surgery
- Severe non-cardiovascular comorbidity with life expectancy < 3 months
- Severe renal failure, defined as Glomerular Filtration Rate (GFR) <15ml/min
- Severe hepatic insufficiency (Child-Pugh score B to C),
- Active liver disease,
- Contraindications against performance of MRI (pacemaker/ICD), previous implantation non-MRI capable protheses
- Patients considered unreliable by the investigator, or having a life expectancy less than the expected duration of the trial