Stroke Treatment With Acute Reperfusion and Simvastatin

December 20, 2016 updated by: Hospital Universitari Vall d'Hebron Research Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Albacete, Spain
        • Hospital Universitario de Albacete
      • Barcelona, Spain
        • Hospital Universitario de Bellvitge
      • Barcelona, Spain
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain
        • Hospital de Santa Creu I Sant Pau
      • Bilbao, Spain
        • Hospital de Basurto
      • Burgos, Spain
        • Hospital General Yagüe
      • Ciudad Real, Spain
        • Hospital de Ciudad Real
      • Donostia, Spain
        • Hospital de Donostia
      • León, Spain
        • Hospital de Leon
      • Lleida, Spain
        • Hospital Arnau de Vilanova de Lleida
      • Madrid, Spain
        • Hospital Universitario Ramón y Cajal
      • Mollet del Vallès, Spain
        • Hospital de Mollet
      • Palma de Mallorca, Spain
        • Hospital Son Dureta
      • Sabadell, Spain
        • Consorci Sanitari Parc Tauli
      • Sevilla, Spain
        • Hospital Virgen del Rocío
      • Tarragona, Spain
        • Hospital Universitario Joan XXIII
      • Terrassa, Spain
        • Hospital Mutua De Terrassa
      • Valencia, Spain
        • Hospital Universitario La Fe
      • Valladolid, Spain
        • Hospital Universitario de Valladolid
    • Barcelona
      • Vic, Barcelona, Spain
        • Hospital General de Vic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: Seventh day (or discharge) and third month
Seventh day (or discharge) and third month

Secondary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 24 to 78 hours
24 to 78 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

February 18, 2010

First Submitted That Met QC Criteria

February 19, 2010

First Posted (Estimate)

February 22, 2010

Study Record Updates

Last Update Posted (Estimate)

December 21, 2016

Last Update Submitted That Met QC Criteria

December 20, 2016

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STARS07
  • EC07/90195 (Other Identifier: Fondo de Investigación Sanitaria)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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