SIMSAB
Effect Of Simvastatin On Endothelial Dysfunction, Fibrinolysis, Coagulation And Inflammation After Aneurysmal Subarachnoid Hemorrhage
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Status:
The trial has been completed. 32 patients were included.
Purpose:
To investigate whether statins can restore endothelial cell damage, activate fibrinolysis, and improve coagulation and inflammation after aneurysmal subarachnoid hemorrhage.
Interventions:
Simvastatin
HMG-CoA reductase inhibitor; lowers cholesterol
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Year Started:
2006
Year Finished:
2009
Design:
Single center, prospective, randomized, double-blind, placebo-controlled trial.
Inclusion Criteria
Patients suffering from aneurysmal subarachnoid hemorrhage as shown by CT scan; perimesencephalic hemorrhage pattern on the CT scan and appropriate aneurysm shown by conventional CTA or angiography; negative CT scan with evidence of bleeding in the cerebrospinal fluid and aneurysm shown by angiography.
Exclusion Criteria
Patients using aspirin, warfarin, or statins; contra-indication for simvastatin; kidney insufficiency; if death appears imminent; pregnancy or lactation.
Patient Involvement:
Patients are randomized for simvastatin 80 mg a day or placebo for 14 days. Blood withdrawal and transcranial Doppler examination is performed before the study drug is started and at days 4, 7, 10, 14 and 17 after SAH.
Primary Outcome:
The effect of simvastatin on parameters of endothelial function, fibrinolysis, coagulation and inflammation after SAH.
Secondary Outcome:
The occurrence of cerebral ischemia after SAH; outcome on the Glasgow Outcome Scale and AMC Linear Disability Scale at 3 and 6 months after SAH; the relation between vasospasm as observed on transcranial Doppler examination and parameters of fibrinolysis, coagulation, endothelium dysfunction and inflammation.
Results:
A total of 32 patients were included. There were no statistically significant differences in clinical baseline characteristics. With regard to primary outcomes, there were significant differences by treatment group for total cholesterol and low-density lipoprotein (LDL) cholesterol (P<0.0001), but not for parameters of coagulation, fibrinolysis, endothelium function, and inflammation. With regard to secondary outcomes, no differences were observed in the incidence of transcranial Doppler vasospasm, clinical signs of DCI, and poor outcome. We conclude that both the primary and secondary outcome results of this study do not support a beneficial effect of simvastatin in patients with SAH.
Source of Information:
Presented at the 2007 International Stroke Conference [February 2007].
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Web Links and Publications:
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This information last updated on: 11/11/2009
Reviewed on: 05/13/2009.
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