Stroke Treatment With Acute Reperfusion and Simvastatin

NCT01073007 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2016-12-21

No results posted yet for this study

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.

Conditions

  • Stroke, Acute

Interventions

DRUG

Simvastatin

Simvastatin 40 mgrs daily for three months.

Sponsors & Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute

    lead OTHER

Principal Investigators

  • Joan Montaner, MD, PhD · Hospital Vall Hebron Research Institute

  • Marc Ribó, MD, PhD · Hospital Vall Hebron. Stroke Unit

  • Carmen Jimenez, MD · Hospital Son Dureta. Stroke Unit.

  • Francesc Muñoz, MD · Hospital de Mollet

  • David Canovas, MD · Consorci Sanitari Parc Taulí Sabadell.

  • Jurek Krupinski, MD · Hospital Mutua de Terrassa. Neurology Department

  • Maite Martinez-Zabaleta, MD · Hospital de Donostia. Neurology Department

  • Francisco Javier De la Torre Laviana, MD · Hospital Virgen del Rocio. Stroke Unit.

  • Marimar Freijo, MD · Hospital de Basurto

  • Tomás Segura, MD · Hospital Universitario de Albacete

  • Juan Arenillas, MD, PhD · Hospital Universitario de Valladolid

  • Jose Manuel Flores, MD · Hospital de Ciudad Real

  • Francisco Alonso, MD, PhD · Hospital General de Vic

  • Jaime Masjuán Vallejo, MD · Hospital Universitario Ramón y Cajal. Stroke unit.

  • Francisco Rubio Borrego, MD, PhD · Hospital Universitario de Bellvitge. Stroke Unit.

  • Javier Tejada García, MD · Hospital de Leon

  • Aida Lago Martín, MD, PhD · Hospital Universitario la Fe. Stroke Unit.

  • Yolanda Bravo Anguiano, MD · Hospital General Yagüe

  • Xavier Ustrell Roig, MD, PhD · Hospital Universitario Joan XXIII

  • Francisco Purroy García, MD, PhD · Hospital Universitario Arnau de Vilanova de Lleida

  • Raquel Delgado Mederos, MD, PhD · Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01073007 on ClinicalTrials.gov