Health Condition 1: G00-G99- Diseases of the nervous system
Conditions
Interventions
Intervention1: NIL: NIL
Intervention2: Alteplase injection: Dosage: 0.9 mg/kg of body weight with maximum dosage of 90mg
Frequency: Once stat dose
Route of administration: Intravenous infusion
Durati
Sponsors
All India Institute Of Medical Sciences
Eligibility
Inclusion criteria
Inclusion criteria: -Age > 18 years -Acute Ischemic Stroke symptom onset within past 4.5-9 hours -Acute Ischemic Stroke consistent within ICA, MCA or ACA territory -Baseline mRS 0-2 -NIHSS score of >5 at baseline and prior to randomization -Imaging eligibility with perfusion lesion ischemic core mismatch greater than 1.8 between the volume of hypoperfusion and volume of the ischemic core, an absolute difference in volume greater than 10 ml, and an ischemic-core volume of less than 70 ml
Exclusion criteria
Exclusion criteria: -Imaging shows more than 1/3 of MCA territory infarct or more than one vascular territory -Acute or previous intracranial hemorrhage -Active internal organ bleeding - Known hypersensitivity to Alteplase - Seizures at stroke onset -Severe, uncontrolled hypertension - Treatment with a thrombolytic within last 3 months -Prior ischemic stroke, severe head trauma, intracranial/intraspinal injury within 3 months -Gastrointestinal malignancy or GI bleed within 21 days -Occlusion in > 1 vascular territory
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The safety of Bridging therapy with intravenous Alteplase along with standard of care as compared to standard of care alone in treatment of imaging eligible acute ischemic stroke patients with large vessel occlusion presenting within 4.5 to 9 hours of onset.Timepoint: 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients in who planned Mechanical Thrombectomy was not performed.Timepoint: 90 days ;Proportion of patients with a Barthel Index score of 95Timepoint: 90 days;Proportion of patients with angiography reperfusion (treatment in cerebral ischemia {TICI} 2b/3 or TICI 3) at completion of angiography procedure (only for patients treated with endovascular therapy.Timepoint: 90 days;Proportion of patients with functional independence, define as mRS of 0 to 2Timepoint: 90 days;Proportion of patients with good recovery based on the Glasgow Outcome ScaleTimepoint: 90 days;Proportion of patients with reperfusion at 24 hours post randomization, define as a more than 90% reduction in time to maximum more than 6 seconds lesion volume. Timepoint: 90 days;To determine the rate of recanalization of vessel causing stroke Timepoint: 90 days;To determine the rate of reduction of need of decompressive hemicraniectomy in cases of large vessels obstruction.Timepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Awadh Kishor Pandit
All India Institute Of Medical Sciences
Outcome results
None listed