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OpenTrials
Completed

NCT Number: NCT01073007

Stroke Treatment With Acute Reperfusion and Simvastatin

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.

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Key information

Conditions

Stroke, Acute Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital General de Vic, Vic, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

simvastatin

Drug

Simvastatin 40 mgrs daily for three months.

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.

    Time frame: 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.

    Time frame: 24 to 78 hours

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2014
Study completion
2014
First posted
Feb 22, 2010
Registry last updated
Dec 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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