Clinical trial NCT01073007: Stroke Treatment With Acute Reperfusion and Simvastatin
Official title: Multicentric, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Simvastatin in the Acute Phase of Ischemic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke, Acute
Keywords: Acute Stroke
tissue plasminogen activator
simvastatin
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2010-02-22
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Seventh day (or discharge) and third month
Secondary outcomes:
measure: 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.
timeFrame: 24 to 78 hours
Other outcomes:
Locations:
city: Vic
country: Spain
facility: Hospital General de Vic
state: Barcelona
city: Albacete
country: Spain
facility: Hospital Universitario de Albacete
city: Barcelona
country: Spain
facility: Hospital de Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Bilbao
country: Spain
facility: Hospital de Basurto
city: Burgos
country: Spain
facility: Hospital General Yagüe
city: Ciudad Real
country: Spain
facility: Hospital de Ciudad Real
city: Donostia
country: Spain
facility: Hospital de Donostia
city: León
country: Spain
facility: Hospital de León
city: Lleida
country: Spain
facility: Hospital Arnau de Vilanova de Lleida
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Mollet del Vallès
country: Spain
facility: Hospital de Mollet
city: Palma de Mallorca
country: Spain
facility: Hospital Son Dureta
city: Sabadell
country: Spain
facility: Consorci Sanitari Parc Tauli
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Tarragona
country: Spain
facility: Hospital Universitario Joan XXIII
city: Terrassa
country: Spain
facility: Hospital Mutua de Terrassa
city: Valencia
country: Spain
facility: Hospital Universitario La Fe
city: Valladolid
country: Spain
facility: Hospital Universitario de Valladolid
Study officials:
affiliation: Hospital Vall Hebron Research Institute
name: Joan Montaner, MD, PhD
role: STUDY_DIRECTOR
affiliation: Hospital Vall Hebron. Stroke Unit
name: Marc Ribó, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Son Dureta. Stroke Unit.
name: Carmen Jimenez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Mollet
name: Francesc Muñoz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Consorci Sanitari Parc Taulí Sabadell.
name: David Canovas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Mutua de Terrassa. Neurology Department
name: Jurek Krupinski, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Donostia. Neurology Department
name: Maite Martinez-Zabaleta, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Virgen del Rocio. Stroke Unit.
name: Francisco Javier De la Torre Laviana, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Basurto
name: Marimar Freijo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Albacete
name: Tomás Segura, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Valladolid
name: Juan Arenillas, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Ciudad Real
name: Jose Manuel Flores, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General de Vic
name: Francisco Alonso, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramón y Cajal. Stroke unit.
name: Jaime Masjuán Vallejo, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario de Bellvitge. Stroke Unit.
name: Francisco Rubio Borrego, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Leon
name: Javier Tejada García, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario la Fe. Stroke Unit.
name: Aida Lago Martín, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital General Yagüe
name: Yolanda Bravo Anguiano, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Joan XXIII
name: Xavier Ustrell Roig, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Arnau de Vilanova de Lleida
name: Francisco Purroy García, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
name: Raquel Delgado Mederos, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Montaner J, Bustamante A, Garcia-Matas S, Martinez-Zabaleta M, Jimenez C, de la Torre J, Rubio FR, Segura T, Masjuan J, Canovas D, Freijo M, Delgado-Mederos R, Tejada J, Lago A, Bravo Y, Corbeto N, Giralt D, Vives-Pastor B, de Arce A, Moniche F, Delgado P, Ribo M; STARS Investigators. Combination of Thrombolysis and Statins in Acute Stroke Is Safe: Results of the STARS Randomized Trial (Stroke Treatment With Acute Reperfusion and Simvastatin). Stroke. 2016 Nov;47(11):2870-2873. doi: 10.1161/STROKEAHA.116.014600. Epub 2016 Oct 6.