Stroke, Acute
Conditions
Keywords
Acute Stroke, tissue plasminogen activator, simvastatin
Brief summary
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.
Interventions
DRUGSimvastatin
Simvastatin 40 mgrs daily for three months.
Sponsors
Hospital Universitari Vall d'Hebron Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | 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
| Measure | 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 |
Countries
Spain
Outcome results
None listed