Stroke Treatment with Acute Reperfusion and Simvastatin "STARS07"

Recruiting

Phase N/A 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, respectively.

Interventions

  • Simvastatin Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol
  • Placebo Drug
    Intervention Desc: A placebo is a substance or procedure which a patient accepts as a medicine or therapy but which has no specific therapeutic activity for the condition.

Trial Design

Interventional, Treatment, Single group assignment, doble blind, randomized, placebo-controlled, Efficacy/Safety Study.

Patient Involvement

Patient will be randomized to one of two arms: 1) simvastatin or 2) placebo. Patient will have neurological and functional oucomes evaluated at seventh day/discharge or at the third month.

Outcomes

Type Measure Time Frame Safety Issue
Primary 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.
Secondary To demonstrate that the combination of simvastatin plus t-PA is safe and is not associated with higher rates of hemorrhagic transformation than the administration of t-PA alone.

Sponsors

Joan Montaner, MD, PhD Neurovascular Research Laboratory Research Institute, Vall d’Hebron Hospital Barcelona, Spain Phone: +34-934894029 e-mail: 31862jmv@comb.cat