combination antithrombotic treatment for prevention of recurrent ischemic stroke in intracranial atherosclerotic disease

Conditions: Ischemic Stroke; Intracranial Atherosclerotic Disease

Summary: catis-icad is a clinical pilot study in which patients who have had a recent ischemic stroke, that is a stroke caused by a blood clot or a narrowing of the blood vessels in the brain due to the build up of plaque, will be randomly assigned to receive either low-dose rivaroxaban + aspirin or aspirin alone.


Eligibility criteria:
inclusion criteria: 1. age ≥ 40 years 2. recent brain ischemia attributed to intracranial atherosclerotic stenosis of 30-99% as evidenced by ct or mr angiography, occurring between 7 to 100 days prior to randomization and consisting of either: 1. a high-risk tia defined as tia with motor and/or speech involvement or 2. an ischemic stroke 3. written informed consent consistent with local regulations governing research in human subjects exclusion criteria: 1. indication for dapt for \> 90 days on guideline recommendations or investigator ́s judgment; e.g., cardiac stenting. 2. indication for chronic anticoagulation based on guideline recommendations or investigator ́s judgment; e.g. patient with prosthetic mechanical valve, venous thromboembolism, hypercoagulable state 3. atrial fibrillation or a history of atrial fibrillation 4. intracranial arterial occlusion (e.g. 100% stenosis) responsible for the acute brain ischemia 5. intracranial arterial stenosis secondary to causes other than atherosclerosis 6. extracranial carotid artery disease ipsilateral to the qualifying brain ischemia with a plan for carotid revascularization 7. intraluminal thrombus 8. subdural hematoma within 12 months of randomization 9. previous spontaneous hemorrhagic stroke (e.g. intracerebral or subarachnoid hemorrhage) 10. traumatic brain hemorrhage within 1 month of randomization 11. contraindication for mri scan (e.g. pacemaker incompatible with mri) 12. advanced kidney disease (recent estimated gfr \<30 ml per minute) 13. modified rankin scale (mrs) \>=4 at entry 14. platelet count less than 100,000/mm3 at enrolment or other bleeding diathesis 15. uncontrollable hypertension with systolic bp/ diastolic bp consistently above180/100mmhg after treatment 16. known hypersensitivity to either asa or rivaroxaban 17. life expectancy less than 6 months 18. concomitant use of strong inhibitors of both cytochrome p450 isoenzyme 3a4 (cyp3a4) and p-glycoprotein (p-gp), i.e., human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, or posaconazole, if used systemically 19. female of childbearing potential who are not surgically sterile, or, if sexually active not willing to use adequate contraceptive measures with a failure rate less than 1% per year (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, male partner sterilization) before entry and throughout the study, as well as pregnant or breast-feeding women 20. inability to adhere to study procedures 21. close affiliation with the investigational site; e.g. a close relative of the investigator, dependent person (e.g., employee or student of the investigational site) 22. previous randomization to this study or participating in a study with an investigational drug or medical device at the time of randomization 23. antiphospholipid antibody syndrome

Keywords: pilot study rivaroxaban factor xa inhibitors intracranial atherosclerotic disease