Health Condition 1: G460- Middle cerebral artery syndrome Health Condition 2: G461- Anterior cerebral artery syndrome Health Condition 3: G462- Posterior cerebral artery syndrome Health Condition 4: G463- Brain stem stroke syndrome Health Condition 5: G464- Cerebellar stroke syndrome Health Condition 6: G468- Other vascular syndromes of brainin cerebrovascular diseases Health Condition 7: G465- Pure motor lacunar syndrome
Conditions
Interventions
Intervention1: Rivaroxaban: Mode of administration: Oral
Dose:
Body weight (kg) Frequency
2.6 to less than 3: 0.8 mg tid,
3 to less than 4: 0.9 mg tid
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: Children aged 29 days to less than 15 years with acute arterial ischemic and venous stroke, confirmed on neuroimaging Within 28 days of stroke onset
Exclusion criteria
Exclusion criteria: Stroke with haemorrhagic transformation having (a) significant Intraventricular haemorrhage, (b) causing mass effect, (c) parenchymal bleed involving greater than two-third of vascular territory Stroke in patient with infective endocarditis Platelet count less than 50,000 per decilitre. Coagulopathy INR greater than 3 with or without active bleeding Severe sepsis; Multi-organ dysfunction; Shock requiring vasoactive support; Chronic Advanced illness Active bleeding (like Disseminated Intravascular coagulation, Severe Gastrointestinal bleed) An estimated glomerular filtration rate less than 30 mL per min per 1.73 m2 (in infants: serum creatinine more than 97.5th percentile). Hepatic disease which is associated with either: coagulopathy with increased risk of clinically relevant bleeding, or alanine aminotransferase more than five times the upper limit of normal or total bilirubin more than twice ULN with direct bilirubin greater than 20 percent of the total Hypertension defined as systolic and/or diastolic blood pressure greater than 95th age percentile or more than 130/80-139/89 mmHg whichever is lower for children aged 1-13 years; and 130/80-139/89 mm Hg for children 13 years or beyond Diagnosis of arteriopathy where aspirin is indicated (Moyamoya disease, Mineralizing angiopathy) Stroke associated with infective arteriopathy (Tubercular meningitis)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the composite score of the proportion of children with no recanalization or deterioration on neuroimaging performed at 3 months of treatment, proportion of deaths or major bleeding while on treatment for 3 month duration, proportion of children with symptomatic recurrence of thromboembolism during the treatment period of 3 months and proportion of children with asymptomatic deterioration of thromboembolism on neuroimaging freedom at 3 months of treatment; in both treatment arms. Timepoint: 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of patients with symptomatic recurrence at 3 months of therapy in each group Number of patients with asymptomatic deterioration at 3 months of therapy on repeat imaging To assess composite of symptomatic recurrence and asymptomatic recurrence on neuro-imaging at 3 months Number of total or partial recanalization in each arm after 3 months of therapy on repeat imaging Number of adverse events in both treatment group To assess the incidence of major and clinically relevant non major bleeding while on therapy To assess the compliance within each treatment group (defined by greater than 80 percent ) Timepoint: 3 months | — |
Countries
India
Contacts
Public ContactDr Renu Suthar
PGIMER, Chandigarh
Outcome results
None listed