NCT01073007

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2009

Longer than P75 for phase_4

Geographic Reach
1 country

20 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

February 18, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 22, 2010

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 21, 2016

Status Verified

June 1, 2014

Enrollment Period

5.2 years

First QC Date

February 18, 2010

Last Update Submit

December 20, 2016

Conditions

Stroke, Acute

Keywords

Acute Stroketissue plasminogen activatorsimvastatin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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

Study Arms (2)

Simvastatin

EXPERIMENTAL

Simvastatin 40 mg daily for 3 months.

Drug: Simvastatin

Placebo

PLACEBO COMPARATOR
Drug: Simvastatin

Interventions

SimvastatinDRUG

Simvastatin 40 mgrs daily for three months.

PlaceboSimvastatin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Pregnancy or breastfeeding.
  • Clinical or radiological evidence on admission of intracranial hemorrhage, hemorrhagic infarction or tumor.
  • 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.
  • Documented hypersensibility to statins.
  • Drug abuse.
  • Expected short life-expectancy related to other systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Hospital General de Vic

Vic, Barcelona, Spain

Location

Hospital Universitario de Albacete

Albacete, Spain

Location

Hospital de Santa Creu i Sant Pau

Barcelona, Spain

Location

Hospital Universitario de Bellvitge

Barcelona, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, Spain

Location

Hospital de Basurto

Bilbao, Spain

Location

Hospital General Yagüe

Burgos, Spain

Location

Hospital de Ciudad Real

Ciudad Real, Spain

Location

Hospital de Donostia

Donostia / San Sebastian, Spain

Location

Hospital de León

León, Spain

Location

Hospital Arnau de Vilanova de Lleida

Lleida, Spain

Location

Hospital Universitario Ramón y Cajal

Madrid, Spain

Location

Hospital de Mollet

Mollet del Vallès, Spain

Location

Hospital Son Dureta

Palma de Mallorca, Spain

Location

Consorci Sanitari Parc Tauli

Sabadell, Spain

Location

Hospital Virgen del Rocío

Seville, Spain

Location

Hospital Universitario Joan XXIII

Tarragona, Spain

Location

Hospital Mutua de Terrassa

Terrassa, Spain

Location

Hospital Universitario La Fe

Valencia, Spain

Location

Hospital Universitario de Valladolid

Valladolid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 27758944DERIVED

MeSH Terms

Conditions

Stroke

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • Joan Montaner, MD, PhD

    Hospital Vall Hebron Research Institute

    STUDY DIRECTOR

  • 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

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2010

First Posted

February 22, 2010

Study Start

April 1, 2009

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

December 21, 2016

Record last verified: 2014-06

Locations

ES(20)