Stroke Treatment With Acute Reperfusion and Simvastatin

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT01073007
First received: February 18, 2010
Last updated: June 18, 2015
Last verified: June 2014
  Purpose

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 Intervention Phase
Stroke, Acute
Drug: Simvastatin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Hospital Universitari Vall d'Hebron Research Institute:

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. [ Time Frame: Seventh day (or discharge) and third month ] [ Designated as safety issue: No ]

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. [ Time Frame: 24 to 78 hours ] [ Designated as safety issue: Yes ]

Enrollment: 104
Study Start Date: April 2009
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simvastatin
Simvastatin 40 mg daily for 3 months.
Drug: Simvastatin
Simvastatin 40 mgrs daily for three months.
Placebo Comparator: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073007

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

No publications provided

Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT01073007     History of Changes
Other Study ID Numbers: STARS07, EC07/90195
Study First Received: February 18, 2010
Last Updated: June 18, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Hospital Universitari Vall d'Hebron Research Institute:
Acute Stroke
tissue plasminogen activator
simvastatin

Additional relevant MeSH terms:
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Vascular Diseases
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on July 26, 2015