Stroke Treatment With Acute Reperfusion and Simvastatin

Completed

Phase 4 Results N/A

Trial Description

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.

Conditions

Interventions

  • Simvastatin Drug
    Intervention Desc: Simvastatin 40 mgrs daily for three months.
    ARM 1: Kind: Experimental
    Label: Simvastatin
    Description: Simvastatin 40 mg daily for 3 months.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary 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 No
Secondary 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 Yes

Sponsors