Back to results

Stroke Treatment With Acute Reperfusion and Simvastatin

Primary Purpose

Stroke, Acute

Status

Completed

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

Simvastatin

About this trial

This is an interventional treatment trial for Stroke, Acute focused on measuring Acute Stroke, tissue plasminogen activator, simvastatin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simvastatin

Placebo

Arm Description

Simvastatin 40 mg daily for 3 months.

Outcomes

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.

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.

Full Information

NCT ID

NCT01073007

First Posted

February 18, 2010

Last Updated

December 20, 2016

Sponsor

Hospital Universitari Vall d'Hebron Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01073007

Brief Title

Stroke Treatment With Acute Reperfusion and Simvastatin

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2014

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

June 2014 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hospital Universitari Vall d'Hebron Research Institute

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Acute

Keywords

Acute Stroke, tissue plasminogen activator, simvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

104 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Simvastatin

Arm Type

Experimental

Arm Description

Simvastatin 40 mg daily for 3 months.

Arm Title

Placebo

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Simvastatin

Intervention Description

Simvastatin 40 mgrs daily for three months.

Primary Outcome Measure Information:

Title

Time Frame

Seventh day (or discharge) and third month

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials: