Efficacy And Safety of Injection Tenecteplase in 4.5 to 24 hours imaging Eligible Window patients with Acute Ischemic Stroke.

Not Applicable

Conditions: Health Condition 1: I639- Cerebral infarction, unspecified

Registration Number: CTRI/2022/03/040718

Lead Sponsor: Department of Science and Technology Science and Engineering Research Board Government of India

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

-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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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