Health Condition 1: I639- Cerebral infarction, unspecified
Conditions
Interventions
Intervention1: Injection Tenecteplase: 0.25 mg/kg
maximum 25 mg
Frequency: Once stat dose
Route of administration: Intravenous bolus
Control Intervention1: Placebo and Standard of Care: Standard of care which is already approved for management of ac
Sponsors
Department of Science and Technology Science and Engineering Research Board Government of India
Eligibility
Inclusion criteria
Inclusion criteria: -Age > 18 years -Acute Ischemic Stroke symptom onset within past 4.5-24 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 -Iimaging 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 tenecteplase - 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 |
|---|---|
| To determine efficacy and safety of tenecteplase compared with only standard of care using the ordinal analysis of the modified Ranking scale (mRS) score at Day 90.Timepoint: 90 Days | — |
Secondary
| Measure | Time frame |
|---|---|
| Median NIHSS scoreTimepoint: 90 days;Proportion of patients in whom planned MT was not performedTimepoint: 90 days;Proportion of patients with a Barthel Index score of more than 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 recanalization at 24 hours post randomization, define as complete or partial recanalization on computed tomography angiography or magnetic resonance angiographyTimepoint: 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 volumeTimepoint: 90 days | — |
Countries
India
Contacts
Public ContactDr Awadh Kishor Pandit
All India Institute Of Medical Sciences
Outcome results
None listed