Clinical Research Studies

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

• Conditions:
  High Risk Tia
  Stroke
• Age: Between 18 Year(s) - 100 Year(s)
• Gender: Male or Female

• Other Inclusion Criteria:
  

  1. 18 years of age or older
  2. Acute onset of neurological deficit attributed to noncardioembolic focal brain ischemia due to:
  • Non-cardioembolic ischemic stroke and either of the following:
    • Persistent signs and symptoms of stroke lasting for = 24 hours or
    • Acute ischemic brain infarction documented by magnetic resonance imaging (MRI; diffusion weight imaging), standard computed tomography (CT) or perfusion CT1 that could account for the clinical presentation.
  OR
  • High-risk TIA with complete resolution of symptoms within < 24 hours and an ABCD2
  3. At least one of the following criteria
  • Cerebrovascular atherosclerosis defined as vascular imaging (CTA, MRA, ultrasound, DSA) or
  • Medical history of atherosclerosis or
  • Brain imaging demonstrating an acute non-lacunar infarct (CT, CT perfusion or DWI MRI) defined as cortical location
  4. If no brain infarct is documented prior to randomization at least one of the following needs to be present: motor deficits, speech deficits (aphasia/dysarthria), visual deficits (hemianopsia) and/or neglect.
  5. Imaging of brain (CT or MRI) prior to randomization ruling out hemorrhagic stroke or another pathology that could explain symptoms (e.g. brain tumor, abscess)
  6. Plan for secondary prevention of stroke/TIA with single or dual antiplatelet therapy including ASA, clopidogrel, ticagrelor, prasugrel, cilostazol and dipyridamole and in line with local guidelines.

  
  

You may not be eligible for this study if the following are true:

• 1. Recent ischemic stroke within 7 days before index stroke event
  2. Strokes following procedures (e.g. TAVI, CABG) or strokes due to other rare causes (e.g. bacterial endocarditis, vertebral artery dissections)
  3. Known pre-stroke Modified Rankin Score (mRS) = 4
  4. Dysphagia with inability to safely swallow study medication at time of randomization
  5. History of atrial fibrillation / flutter, left ventricular thrombus, mechanical valve or other cardioembolic source of stroke requiring anticoagulation
  6. Sustained uncontrolled hypertension after index stroke/TIA event3
  7. Known vascular malformation of the brain with high risk for bleeding (except isolated cavernoma, aneurysm treated and secured, or aneurysm with diameter <5 mm)
  8. Active non-trivial bleeding; known chronic bleeding disorder (e.g. von Willebrand disease); history of non-traumatic intracranial hemorrhage (does not include cerebral microbleeds or asymptomatic hemorrhagic transformation of an ischemic stroke); other non-traumatic major bleeding or clinically significant gastrointestinal bleeding within last 6 months
  9. Known significant liver disease (e.g. acute hepatitis, chronic active hepatitis, cirrhosis, or signs of coagulopathy) or known hepatic insufficiency classified as Child-Pugh B or C
  10. End stage renal disease requiring dialysis or expected to be started on dialysis within the next 12 months
  11. Major surgery during the last 30 days
  
  Prior / Concomitant Therapy
  
  
  12. Concomitant use, planned use or anticipated need for:
  • Oral anticoagulation
  • Full dose and/or long-term anticoagulation therapy with heparin/LMWH during study conduct
  • Chronic (more than 4 weeks continuous) therapy with NSAIDs during the study conduct
  • Concomitant use of combined P-gp and strong/moderate CYP3A4 inducers, e.g. carbamazepine, phenobarbital, St John’s wort7, as well as within 14 days (or at least five half-lives of the active substance, whichever is longer) before randomization
  • Concomitant use of combined P-gp and strong CYP3A4 inhibitors e.g. human immunodeficiency virus protease inhibitors, systemically used azole antimycotic agents (e.g. ketoconazole), clarithromycin, nefazodone7, as well as within 14 days (or at least five half-lives of the active substance, whichever is longer) before randomization
  • Herbal or traditional medicine, and / or supplements with known anticoagulant and / or antiplatelet effect (a list of the most commonly used ones will be provided separately).
  13. Previous (within 30 days of randomization or 5 half-lives of the investigational drug, whichever is longer) or concomitant participation in another clinical study with investigational medicinal product(s) or device(s). Registries and observational studies are allowed.
  
  Other Exclusions
  
  
  14. Unable to start study intervention within 4 hours from randomization
  15. Known current alcohol and / or illicit drug abuse that may interfere with the participant’s safety and / or compliance
  16. Close affiliation with the investigational site; e.g. a close relative of the investigator or a dependent person (e.g. employee or student of the investigational site or the sponsor)
  17. Any other history, condition or therapy, or uncontrolled intercurrent illness which would make the participant unsuitable for the study (e.g. non-compliance) or otherwise vulnerable (e.g. participant in custody by order of an authority or a court), or life expectancy < 12 months.