Stroke Treatment With Acute Reperfusion and Simvastatin

Sponsor

Hospital Universitari Vall d'Hebron Research Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01073007

Collaborator

(none)

104

Enrollment

Locations

Arms

Duration (Months)

5.2

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke, Acute	Drug: Simvastatin	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

104 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Multicentric, Randomized, Double-blind Clinical Trial to Evaluate the Efficacy of Simvastatin in the Acute Phase of Ischemic Stroke

Study Start Date :

Apr 1, 2009

Actual Primary Completion Date :

Jun 1, 2014

Actual Study Completion Date :

Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Simvastatin Simvastatin 40 mg daily for 3 months.	Drug: Simvastatin Simvastatin 40 mgrs daily for three months.
Placebo Comparator: Placebo	Drug: Simvastatin Simvastatin 40 mgrs daily for three months.

Arm

Intervention/Treatment

Experimental: Simvastatin

Simvastatin 40 mg daily for 3 months.

Drug: Simvastatin

Simvastatin 40 mgrs daily for three months.

Placebo Comparator: Placebo

Drug: Simvastatin

Simvastatin 40 mgrs daily for three months.

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital General de Vic	Vic	Barcelona	Spain
2	Hospital Universitario de Albacete	Albacete		Spain
3	Hospital de Santa Creu i Sant Pau	Barcelona		Spain
4	Hospital Universitario de Bellvitge	Barcelona		Spain
5	Hospital Universitario Vall d'Hebron	Barcelona		Spain
6	Hospital de Basurto	Bilbao		Spain
7	Hospital General Yagüe	Burgos		Spain
8	Hospital de Ciudad Real	Ciudad Real		Spain
9	Hospital de Donostia	Donostia		Spain
10	Hospital de León	León		Spain
11	Hospital Arnau de Vilanova de Lleida	Lleida		Spain
12	Hospital Universitario Ramón y Cajal	Madrid		Spain
13	Hospital de Mollet	Mollet del Vallès		Spain
14	Hospital Son Dureta	Palma de Mallorca		Spain
15	Consorci Sanitari Parc Tauli	Sabadell		Spain
16	Hospital Virgen del Rocío	Sevilla		Spain
17	Hospital Universitario Joan XXIII	Tarragona		Spain
18	Hospital Mutua de Terrassa	Terrassa		Spain
19	Hospital Universitario La Fe	Valencia		Spain
20	Hospital Universitario de Valladolid	Valladolid		Spain

Sponsors and Collaborators

Hospital Universitari Vall d'Hebron Research Institute

Investigators

Study Director: Joan Montaner, MD, PhD, Hospital Vall Hebron Research Institute
Principal Investigator: Marc Ribó, MD, PhD, Hospital Vall Hebron. Stroke Unit
Principal Investigator: Carmen Jimenez, MD, Hospital Son Dureta. Stroke Unit.
Principal Investigator: Francesc Muñoz, MD, Hospital de Mollet
Principal Investigator: David Canovas, MD, Consorci Sanitari Parc Taulí Sabadell.
Principal Investigator: Jurek Krupinski, MD, Hospital Mutua de Terrassa. Neurology Department
Principal Investigator: Maite Martinez-Zabaleta, MD, Hospital de Donostia. Neurology Department
Principal Investigator: Francisco Javier De la Torre Laviana, MD, Hospital Virgen del Rocio. Stroke Unit.
Principal Investigator: Marimar Freijo, MD, Hospital de Basurto
Principal Investigator: Tomás Segura, MD, Hospital Universitario de Albacete
Principal Investigator: Juan Arenillas, MD, PhD, Hospital Universitario de Valladolid
Principal Investigator: Jose Manuel Flores, MD, Hospital de Ciudad Real
Principal Investigator: Francisco Alonso, MD, PhD, Hospital General de Vic
Principal Investigator: Jaime Masjuán Vallejo, MD, Hospital Universitario Ramón y Cajal. Stroke unit.
Principal Investigator: Francisco Rubio Borrego, MD, PhD, Hospital Universitario de Bellvitge. Stroke Unit.
Principal Investigator: Javier Tejada García, MD, Hospital de Leon
Principal Investigator: Aida Lago Martín, MD, PhD, Hospital Universitario la Fe. Stroke Unit.
Principal Investigator: Yolanda Bravo Anguiano, MD, Hospital General Yagüe
Principal Investigator: Xavier Ustrell Roig, MD, PhD, Hospital Universitario Joan XXIII
Principal Investigator: Francisco Purroy García, MD, PhD, Hospital Universitario Arnau de Vilanova de Lleida
Principal Investigator: Raquel Delgado Mederos, MD, PhD, Hospital Santa Creu i Sant Pau