Stroke, Acute | Stroke Treatment With Acute Reperfusion and Simvastatin
Stroke, Acute research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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.
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:SimvastatinSimvastatin 40 mgrs daily for three months.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
SimvastatinSimvastatin 40 mg daily for 3 months.
Start Date: April 2009
Completed Date: June 2014
Phase: Phase 4
Primary Outcome: 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.
Secondary Outcome: 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.
Study sponsors, principal investigator, and references
Principal Investigator: Joan Montaner, MD, PhD
Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute