Stroke Treatment With Acute Reperfusion and Simvastatin

Phase 4

Completed

• Conditions: Stroke, Acute
• Interventions: Drug: Simvastatin

• Registration Number: NCT01073007
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2010-02-18
• Study First Submitted QC: 2010-02-19
• Study First Posted: 2010-02-22
• Status Verified: 2014-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Last Update Submitted: 2016-12-20
• Last Update Posted: 2016-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin	Simvastatin	Simvastatin 40 mg daily for 3 months.
Placebo	Simvastatin	-

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

Hospital Mutua de Terrassa; 🇪🇸 Terrassa, Spain

Hospital General de Vic; 🇪🇸 Vic, Barcelona, Spain

Hospital Universitario de Albacete; 🇪🇸 Albacete, Spain

Hospital de Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario de Bellvitge; 🇪🇸 Barcelona, Spain

Hospital Universitario Ramón y Cajal; 🇪🇸 Madrid, Spain

Hospital General Yagüe; 🇪🇸 Burgos, Spain

Hospital de Ciudad Real; 🇪🇸 Ciudad Real, Spain

Hospital de Donostia; 🇪🇸 Donostia, Spain

Hospital de León; 🇪🇸 León, Spain

Hospital Arnau de Vilanova de Lleida; 🇪🇸 Lleida, Spain

Hospital de Mollet; 🇪🇸 Mollet del Vallès, Spain

Hospital Son Dureta; 🇪🇸 Palma de Mallorca, Spain

Consorci Sanitari Parc Tauli; 🇪🇸 Sabadell, Spain

Hospital Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital Universitario Joan XXIII; 🇪🇸 Tarragona, Spain

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain

Hospital Universitario de Valladolid; 🇪🇸 Valladolid, Spain

Hospital de Basurto; 🇪🇸 Bilbao, Spain