MISTICS
Markers of Inflammation after Simvastatin in Ischemic Cortical Stroke



Principal Investigator
Julio Montaner

PI Address
Cerebrovascular Unit.
Neurology Department.
Vall d'Hebron Hospital.
Pg. Vall d'Hebron 119-129.
Barcelona 08035. Spain.

Contact Email
31862jmv@comb.es



Trial Phase:Phase I
Study Size Actual:60
Centers Actual:1
Max Time from onset:12 Hours
Follow-up Duration:90 Years
Status:
Enrollment complete. Results presented in May 2004.

Purpose:
To study the safety and efficacy of Simvastatin in the acute phase of ischemic stroke.

Interventions:
Simvastatin
HMG-CoA reductase inhibitor; lowers cholesterol

Location(s):
Spain

Year Presented: 2004
Year Published: 2008


Design:
Pilot, randomized, double-blind, multi-center clinical trial.

Inclusion Criteria
Patients presenting with acute ischemic stroke with cortical involvment between 3 and 12 hours of stroke onset. NIHSS scores between 6 and 20.

Patient Involvement:
Patients were randomized to receive either Simvastatin (n=28) or placebo (n=28) 40mg until day 7 and 20mg until day 90.

Primary Outcome:
Efficacy and neurological outcome at day 1, 3, 5, 7 and 90.

Results:
Patients receiveing Simvastatin improved significantly by day 3 (46.4% vs 17.9%, p<0.022) and had a greater improvement in NIHSS scores at day 90 (-9 points vs -5 points). The Simvastatin group had a higher proportion of patients with great improvement (decrease of more than 8 NIHSS points) at day 90 (10 vs 3, p<0.044) and a higher proportion of patients with dramatic improvement (decrease of 10 points) at day 90 (11 vs 4, p<0.035).

Source of Information:
Presented at 26th Internation Stroke Conference (Feb 2001). Presented at 12th European Stroke Conference (May 2003).

Web Links and Publications:
Simvastatin in the acute phase of ischemic stroke: a safety and efficacy pilot trial.
Eur J Neurol 2008 Jan;15(1):82-90

This information last updated on: 8/14/2008

Reviewed on: 08/14/2008.

UID: 586


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