Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset

Study Overview
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Brief Summary
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This study will compare two ways of treatment for acute ischemic stroke: an endovascular treatment (EVT), defined as intraarterial thrombolysis and/or mechanical thrombectomy as a first choice treatment versus intravenous thrombolytic therapy (IVT) only or followed by EVT in patients with acute ischemic stroke due to a main brain artery occlusion within 4.5 hours after onset. Patients treated with IVT only or with IVT followed by EVT will be analyzed separately.

Official Title
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Efficacy and Security of an Endovascular Treatment as First Choice Procedure Compared With a Standard Intravenous Thrombolytic Therapy Treatment for Patients With Acute Ischemic Stroke Within 4.5 Hours After Onset: A Prospective Cohorts Study

Conditions
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Acute Ischaemic Stroke

Intervention / Treatment
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* Procedure: EVT (endovascular treatment )
* Procedure: IVT (intravenous thrombolytic therapy)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 80 or less years old patients with acute stroke produced by a main artery occlusion NIHSS National Institutes of Health Stroke Scale score greater than 6 (severe neurological impairment) Patients receiving EVT or IVT within 4.5 hours after onset Exclusion Criteria: EVT or IVT contraindication Previous neurological impairment, severe concomitant disease or poor prognosis. Pregnancy or breastfeeding Known hypersensitivity to any study drugs Severe organic disease for which there is not risk compensation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| EVT<br>Patients receiving endovascular treatment (EVT) within 4.5 hours after onset because intravenous thrombolytic therapy (IVT) is contraindicated | Procedure: EVT (endovascular treatment )<br> <br> |
| IVT + EVT<br>Patients receiving intravenous thrombolytic therapy (IVT) followed by endovascular treatment (EVT) within 4.5 hours after onset | Procedure: EVT (endovascular treatment )<br> <br> Procedure: IVT (intravenous thrombolytic therapy)<br> <br> |
| IVT (intravenous thrombolytic therapy)<br>Patients that will received IVT only within 4.5 hours after onset | Procedure: IVT (intravenous thrombolytic therapy)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death within 90 days after onset |  | 90 days | 
| Symptomatic intracranial haemorrhage |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke recovery rate after discharge | Recovery defined as a 10-fold decrease in NIHSS or NIHSS (7 days after onset or at discharge) | From onset to discharge | 
| Functional recovery | Modified Rankin Score (RMS) value | 4.5 hours after onset | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ischaemic Stroke, Main artery occlusion, Endovascular treatment, Intravenous Thrombolytic Therapy