Trial | NCT01073007  Report issue

Title

Stroke Treatment With Acute Reperfusion and Simvastatin
Multicentric, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Simvastatin in the Acute Phase of Ischemic Stroke

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    104
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.
Study Started
Apr 30
2009
Primary Completion
Jun 30
2014
Study Completion
Jun 30
2014
Last Update
Dec 21
2016
Estimate

Drug Simvastatin

Simvastatin 40 mgrs daily for three months.

Simvastatin Experimental

Simvastatin 40 mg daily for 3 months.

Placebo Placebo Comparator

Criteria 

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.
No Results Posted