A Clinical Trial to Assess the Acute Safety and Functional Outcome and Recovery After STROKE: The FIRST Trial

Study Overview
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Brief Summary
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Current literature has only limited information on the natural history of acute ischemic stroke from large vessel occlusion in a stroke cohort who presents within 8 hours from symptom onset, particularly on 90 day functional outcome as defined by the mRS. Data from this trial will advance our knowledge on this important topic and may serve as a bench mark for future trials

Official Title
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Functional Outcome and Recovery After STROKE: The FIRST Trial

Conditions
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Stroke

Intervention / Treatment
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* Other: Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: From 18 to 85 years of age. Evidence of proximal anterior circulation large vessel occlusion (TIMI 0-1)(TICI 0-1) from CT Angiography. Target vessel occlusion may include the anterior circulation. Presented with symptoms consistent with acute ischemic stroke within 8 hours of symptom onset. Patients who presented within 3 hours must be ineligible or refractory to IV rtPA therapy. At time of enrollment, neurological deficit resulting in an NIH Stroke Scale (NIHSS) score greater than 10 Known core infarct volume assessed by CTP, CTA or DWI scans Exclusion Criteria: History of stroke in the past 3 months. Pre-existing neurological or psychiatric disease that could confound the study results such as a pre-stroke mRS score greater than 1 Known severe allergy to contrast media Uncontrolled hypertension (defined as systolic blood pressure greater than 185 mmHg or diastolic blood pressure less than 110 mmHg) CT evidence of the following conditions before enrollment: Significant mass effect with midline shift Evidence of intracranial hemorrhage Treated with endovascular therapy for acute stroke Life expectancy less than 90 days Participation in another clinical investigation that could confound the evaluation of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| acute ischemic stroke<br>Patients presenting with symptoms of acute ischemic stroke within 8 hours from symptom onset and with an imaging-defined large cerebral vessel occlusion. | Other: Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies<br>* The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. Patients with current standard of care other than IV rtPA or IA therapies will be studied.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional outcome at 90 days after presentation as defined by a modified Rankin Score of 0-2. |  | 90 days after presentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Good neurological recovery as defined by a NIHSS score of 0-1 at discharge or a 10-point or more improvement in this scale at discharge. |  | Discharge and 90 days after presentation | 
| All cause mortality |  | Dishcharge and 90 days after presentation | 
| Incidence of symptomatic and asymptomatic hemorrhage |  | Dishcharge and 90 days after presentation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute ischemic stroke, large vessel occlusion, natural history, functional outcome