Stroke Treatment With Acute Reperfusion and Simvastatin

Vall d'Hebron University Hospital (HUVH)

Status and phase

Completed

Phase 4

Conditions

Stroke, Acute

Treatments

Drug: Simvastatin

Study type

Interventional

Funder types

Other

Identifiers

NCT01073007

EC07/90195 (Other Identifier)

STARS07

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.