Comparison of Anti-coagulation and anti-Platelet Therapies for Intracranial Vascular Atherostenosis
Are you eligible to participate in this study?
You may be eligible for this study if you meet the following criteria:
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Conditions: Stroke
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Age: Between 30 Year(s) - 80 Year(s)
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Gender: Male or Female
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Other Inclusion Criteria:
- Symptoms or signs of any duration associated with an infarct on brain imaging that occurred within 30 days prior to randomization
- Index infarct in 1 above is attributed to 70-99% stenosis (or flow gap on MRA) of a major intracranial artery (carotid artery, MCA stem (M1), vertebral artery, or basilar artery) documented by CTA, MRA, or catheter angiography
- Modified Rankin Scale score of =4
- Ability to swallow pills
- Negative pregnancy test in a female who has had any menses in the last 18 months and has not had surgery that would make her unable to become pregnant
- Subject is willing and able to return for all follow-up visits required by the protocol
- Subject is available by phone
- Subject understands the purpose and requirements of the study and can make him/herself understood
- Subject has provided informed consent
You may not be eligible for this study if the following are true:
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- Previous treatment of target lesion with a stent, angioplasty, or other mechanical device, or plan to perform one of these procedures
- Plan to perform concomitant angioplasty or stenting of an extracranial vessel tandem to the symptomatic intracranial stenosis
- Intracranial tumor (except meningioma) or any intracranial vascular malformation
- Thrombolytic therapy within 24 hours prior to randomization
- Progressive neurological signs within 24 hours prior to randomization
- History of any intracranial hemorrhage (parenchymal, subarachnoid, subdural, epidural)
- Intracranial arterial stenosis due to arterial dissection; MoyaMoya disease; any known vasculitic disease; herpes zoster, varicella zoster or other viral vasculopathy; neurosyphilis; any other intracranial infection; any intracranial stenosis associated with CSF pleocytosis; radiation induced vasculopathy; fibromuscular dysplasia; sickle cell disease; neurofibromatosis; benign angiopathy of central nervous system; postpartum angiopathy; suspected vasospastic process; reversible cerebral vasoconstriction syndrome (RCVS); suspected recanalized embolus
- Presence of any of the following unequivocal cardiac sources of embolism: chronic or paroxysmal atrial fibrillation, mitral stenosis, mechanical valve, endocarditis, intracardiac clot or vegetation, myocardial infarction within three months, left atrial spontaneous echo contrast
- Known allergy or contraindication to aspirin, rivaroxaban, clopidogrel, or ticagrelor
- Active peptic ulcer disease, major systemic hemorrhage within 30 days prior to randomization, active bleed or bleeding diathesis, platelets <100,000, hematocrit <30, INR >1.5, clotting factor abnormality that increases the risk of bleeding, current alcohol or substance abuse, uncontrolled severe hypertension (systolic pressure >180 mm Hg or diastolic pressure >115 mm Hg), severe liver impairment (AST or ALT >3 x normal, cirrhosis), or CrCl <15 mL/min or on dialysis
- Major surgery (including open femoral, aortic, or carotid surgery, cardiac) within 30 days prior to randomization or planned within 90 days after randomization
- Any condition other than intracranial arterial stenosis that requires the subject to take any antithrombotic medication other than aspirin
- Severe neurological deficit that renders the subject incapable of living independently
- Dementia or psychiatric problem that prevents the subject from following an outpatient program reliably
- Co-morbid conditions that may limit survival to less than 12 months
- Pregnancy or of childbearing potential and unwilling to use contraception for the duration of this study, or currently breastfeeding
- Current or anticipated concomitant oral or intravenous therapy with strong CYP3A4 inhibitors or CYP3A4 substrates that cannot be stopped for the course of this study
- Enrollment in another study that would conflict with the current study
If you are registered as a volunteer, please log in to contact the study team/express interest in this study.