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Stroke Treatment With Acute Reperfusion and Simvastatin

NCT ID: NCT01073007

Last Updated: 2016-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2014-06-30

Brief Summary

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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

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Conditions

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Stroke, Acute

Keywords

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Acute Stroke tissue plasminogen activator simvastatin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Simvastatin

Simvastatin 40 mg daily for 3 months.

Group Type EXPERIMENTAL

Simvastatin

Intervention Type DRUG

Simvastatin 40 mgrs daily for three months.

Placebo

Group Type PLACEBO_COMPARATOR

Simvastatin

Intervention Type DRUG

Simvastatin 40 mgrs daily for three months.

Interventions

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Simvastatin

Simvastatin 40 mgrs daily for three months.

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joan Montaner, MD, PhD

Role: STUDY_DIRECTOR

Hospital Vall Hebron Research Institute

Marc Ribó, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall Hebron. Stroke Unit

Carmen Jimenez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Son Dureta. Stroke Unit.

Francesc Muñoz, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Mollet

David Canovas, MD

Role: PRINCIPAL_INVESTIGATOR

Consorci Sanitari Parc Taulí Sabadell.

Jurek Krupinski, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Mutua de Terrassa. Neurology Department

Maite Martinez-Zabaleta, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Donostia. Neurology Department

Francisco Javier De la Torre Laviana, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Virgen del Rocio. Stroke Unit.

Marimar Freijo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Basurto

Tomás Segura, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Albacete

Juan Arenillas, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Valladolid

Jose Manuel Flores, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Ciudad Real

Francisco Alonso, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de Vic

Jaime Masjuán Vallejo, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Ramón y Cajal. Stroke unit.

Francisco Rubio Borrego, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario de Bellvitge. Stroke Unit.

Javier Tejada García, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Leon

Aida Lago Martín, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario la Fe. Stroke Unit.

Yolanda Bravo Anguiano, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital General Yagüe

Xavier Ustrell Roig, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Joan XXIII

Francisco Purroy García, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Arnau de Vilanova de Lleida

Raquel Delgado Mederos, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Locations

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Hospital General de Vic

Vic, Barcelona, Spain

Site Status

Hospital Universitario de Albacete

Albacete, , Spain

Site Status

Hospital de Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitario de Bellvitge

Barcelona, , Spain

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital de Basurto

Bilbao, , Spain

Site Status

Hospital General Yagüe

Burgos, , Spain

Site Status

Hospital de Ciudad Real

Ciudad Real, , Spain

Site Status

Hospital de Donostia

Donostia / San Sebastian, , Spain

Site Status

Hospital de León

León, , Spain

Site Status

Hospital Arnau de Vilanova de Lleida

Lleida, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital de Mollet

Mollet del Vallès, , Spain

Site Status

Hospital Son Dureta

Palma de Mallorca, , Spain

Site Status

Consorci Sanitari Parc Tauli

Sabadell, , Spain

Site Status

Hospital Virgen del Rocío

Seville, , Spain

Site Status

Hospital Universitario Joan XXIII

Tarragona, , Spain

Site Status

Hospital Mutua de Terrassa

Terrassa, , Spain

Site Status

Hospital Universitario La Fe

Valencia, , Spain

Site Status

Hospital Universitario de Valladolid

Valladolid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 27758944 (View on PubMed)

Other Identifiers

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EC07/90195

Identifier Type: OTHER

Identifier Source: secondary_id

STARS07

Identifier Type: -

Identifier Source: org_study_id