A Phase 3 interventional study of Ticagrelor + Aspirin and Rivaroxaban + Aspirin in Intracranial Arteriosclerosis and Stroke, sponsored by University of Florida. Active, not recruiting at 114 sites in United States. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by University of Florida · Phase 3, Interventional, and Prevention
The primary goal of the trial is to determine if the experimental arms (rivaroxaban or ticagrelor or both) are superior to the clopidogrel arm for lowering the 1-year rate of ischemic stroke, intracerebral hemorrhage, or vascular death.
The proposed study is relevant to public health because narrowing of brain arteries is one of the most common causes of stroke worldwide. Compelling evidence suggests novel antithrombotic medications could reduce the rate of stroke in patients with narrowed brain arteries. The proposed study will directly compare novel antithrombotic medications to standard care antiplatelet medications for preventing stroke and death from vascular causes in patients with narrowed brain arteries.
93 studies on the registry are indexed under Intracranial Arteriosclerosis; 41 are open to participants now.
This study's planned enrollment of 1,683 is above the median of 194 across 55 interventional studies indexed under Intracranial Arteriosclerosis.
Browse Intracranial Arteriosclerosis studies →University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.
Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects 30-49 years of age are required to meet at least ONE of the following additional criteria below to qualify for the study:
Exclusion Criteria:
Ticagrelor (180mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Drug: Ticagrelor + Aspirin · Other: Risk Factor Management
Clopidogrel (600mg loading dose, then 75mg once daily) and aspirin (81mg daily)
Drug: Clopidogrel + Aspirin · Other: Risk Factor Management
Rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Drug: Rivaroxaban + Aspirin · Other: Risk Factor Management
ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
Also known as: Brilinta
low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
Also known as: Xarelto
clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)
Also known as: Plavix
Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.
Number of participants with parenchymal ICH or non-ICH major hemorrhage
Non-ICH major hemorrhage is derived from the International Society on Thrombosis and Haemostasis (ISTH) criteria consisting of any of the following: * Fatal bleeding * Symptomatic bleeding in a critical area or organ, such as subarachnoid, intraventricular, subdural, epidural, spinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome * Symptomatic bleeding causing a fall in hemoglobin level of 1.24 mmol/L (20g/L or greater) or more, or leading to transfusion of two units or more of whole blood or red cells
Time frame: Up to 12 months
Number of participants with ischemic stroke, intracerebral hemorrhage or vascular death
The definition of ischemic stroke is the American Heart Association definition that includes acute focal signs or symptoms of cerebral, spinal cord, or retinal involvement of any duration associated with imaging, pathological, or other objective evidence of arterial infarction OR clinical evidence of cerebral, spinal cord, or retinal focal arterial ischemic injury based on symptoms persisting greater than or equal to 24 hours.
Time frame: Up to 12 months
Showing the first 100 of 114 sites.
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Intracranial Arteriosclerosis→
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