Mild to moderate stroke due to symptomatic intracranial and extracranial large artery atherosclerotic stenos
Conditions
Interventions
Trial group:Rivaroxaban: 2.5 mg per dose, twice daily, administered continuously.
Placebo group:Rivaroxaban placebo: 2.5 mg per dose, twice daily, administered continuously.
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Aged 18 years or older; 2.Ischemic stroke within 30 days of onset; 3.National Institute of Health stroke scale (NIHSS) score <= 15 at enrollment; 4.Atherosclerotic stenosis of intracranial or extracranial responsible arteries, with a stenosis rate of 50% - 99%; 5.Patients or their agents sign the informed consent form for the study;
Exclusion criteria
Exclusion criteria: 1.Patients with intracranial hemorrhagic diseases confirmed by head CT: hemorrhagic stroke, epidural hematoma, intracranial hematoma, intraventricular hemorrhage, subarachnoid hemorrhage, etc; 2.Patients with infarction with hemorrhagic transformation shown by head CT after onset; 3.History of coagulation disorders, systemic bleeding, thrombocytopenia or neutropenia; 4.mRS score >= 2 before onset; 5.Patients who are expected to need surgical treatment or endovascular treatment within the next 3 month; 6.Patients with diseases clearly requiring anticoagulant therapy (including atrial fibrillation) or who have received anticoagulant drug therapy within 1 month before randomization; 7.Patients allergic to rivaroxaban and its components; 8.Patients with severe hypertension (systolic blood pressure >= 200 mmHg or diastolic blood pressure >= 110 mmHg) before the first administration that cannot be controlled after treatment; 9.Patients with heart rate 120 beats/min; patients with second - degree and third - degree heart block without pacemaker implantation or other malignant arrhythmias; patients with acute myocardial infarction, cardiac interventional therapy or heart failure (NYHA class III and IV) within the past month; 10.History of severe liver or kidney function impairment (ALT, AST > 2.0 times the upper limit of normal value (UNL), serum creatinine (Cr) > 1.5 times UNL); 11.Patients with malignant tumors, blood, digestive or other serious systemic diseases, whose expected survival time is no more than 3 months; 12.Pregnant or lactating women, patients who plan to have children within 3 months after the first administration and those who are unwilling to use contraceptive measures; 13.Patients who participated in other clinical trials within 1 month before this study or are currently participating in other clinical studies; 14.Patients who are deemed unsuitable for participating in the clinical trial by the researcher;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New-onset ischemic stroke after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| Moderate to severe bleeding after randomization (as defined by GUSTO);Any bleeding events after randomization (including severe or moderate bleeding and intracranial hemorrhage);Adverse events after randomization;Vascular death;Hemorrhagic stroke after randomization;New-onset composite vascular events after randomization (including ischemic stroke, transient ischemic attack (TIA), myocardial infarction, and vascular death);Serious adverse events after randomization;Any type of stroke after randomization (including ischemic stroke and hemorrhagic stroke);transient ischemic attack (TIA) after randomization;Myocardial infarction; | — |
Countries
China
Contacts
Public ContactZhang Tong
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed