Stroke Treatment With Acute Reperfusion and Simvastatin

Study Overview
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Brief Summary
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The purpose of this study is to determine whether simvastatin treatment started within the first 12 hours from stroke onset improves neurological and functional outcomes, evaluated at seventh day/discharge or at the third month. Also, to demonstrate that simvastatin is safe and not associated with higher rates of hemorrhagic transformation in patients who receive thrombolysis.

Official Title
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Multicentric, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Simvastatin in the Acute Phase of Ischemic Stroke

Conditions
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Stroke, Acute

Intervention / Treatment
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* Drug: Simvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years acute ischemic stroke (less than 12 hours from stroke onset). Stroke involving MCA-ACA-PCA. NIHSS score 4 to 22. Previous modified Rankin Scale score of 1 or 0. Patient or proxy informed consent. Patients not taking statins for the past six months. Exclusion Criteria: Pregnancy or breastfeeding. Clinical or radiological evidence on admission of intracranial hemorrhage, hemorrhagic infarction or tumor. Seizures at the time of inclusion. Complete or substantial recovery prior to randomization. Patients with ipsilateral neurological deficit that may mask the evaluation of the current event. Liver disease (AST or ALT more than twice upper normality limit). Cardiogenic shock or relevant cardiac failure. Patients with more than five times upper normality limit of CPK. Myocardial infarction or any other thromboembolic event within the previous 30 days. Active infection by the time of inclusion. Documented hypersensibility to statins. Drug abuse. Expected short life-expectancy related to other systemic diseases.

Ages Eligible for Study
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Minimum Age: 18 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simvastatin<br>Simvastatin 40 mg daily for 3 months. | Drug: Simvastatin<br>* Simvastatin 40 mgrs daily for three months.<br>|
| Placebo Comparator: Placebo<br> | Drug: Simvastatin<br>* Simvastatin 40 mgrs daily for three months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of this study is to determine whether simvastatin treatment started within the first 12 hours from stroke onset improves neurological and functional outcomes, evaluated at seventh day/discharge or at the third month. |  | Seventh day (or discharge) and third month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome of this study is to demonstrate that simvastatin is safe and not associated with higher rates of hemorrhagic transformation in patients who receive thrombolysis. |  | 24 to 78 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute Stroke, tissue plasminogen activator, simvastatin