Stroke Treatment With Acute Reperfusion and Simvastatin

Stroke, Acute Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01073007
• Other study ID #: STARS07
• Secondary ID: EC07/90195
• Status: Completed
• Phase: Phase 4
• First received: February 18, 2010
• Last updated: December 20, 2016
• Start date: April 2009
• Est. completion date: June 2014

Study information

• Verified date: June 2014
• Source: Hospital Universitari Vall d'Hebron Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke
• Stroke, Acute

Intervention

Drug:
• Simvastatin
Simvastatin 40 mgrs daily for three months.

Locations

Country	Name	City	State
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	Hospital General de Vic	Vic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes