Skip Navigation LinksHome > May 2013 - Volume 72 - Issue 5 > High-Dose Simvastatin for Aneurysmal Subarachnoid Hemorrhage...
Neurosurgery:
doi: 10.1227/NEU.0b013e31828ab413
Research-Human-Study Protocols

High-Dose Simvastatin for Aneurysmal Subarachnoid Hemorrhage: A Multicenter, Randomized, Controlled, Double-Blind Clinical Trial Protocol

Wong, George Kwok Chu MD*; Liang, Min MD; Tan, Haibin MD§; Lee, Michael Wing Yan FRCS(SN); Po, Yin Chung FRCS; Chan, Kwong Yau FRCS#; Poon, Wai Sang FRCS*

Press Release
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Abstract

BACKGROUND: Experimental evidence has indicated the benefit of simvastatin in the treatment of subarachnoid hemorrhage. However, no clinical data are available to answer whether a high-dose regimen is more effective than a normal-dose regimen, even though the biochemical actions and related neuroprotective mechanisms are thought to be dose related.

OBJECTIVE: To determine whether 80 mg simvastatin daily (high dose) over 3 weeks initiated within 96 hours of the ictus will reduce the incidence of delayed ischemic deficits after subarachnoid hemorrhage compared with 40 mg simvastatin daily (normal dose), leading to improvements in clinical outcomes and thus cost-effectiveness.

METHODS: The study design is a randomized, controlled, double-blind clinical trial (www.ClinicalTrials.gov; identifier: NCT01077206). Two hundred forty patients with aneurysmal subarachnoid hemorrhage (presenting within 96 hours of the ictus) from 6 neurosurgical centers are being recruited over 3 years. The primary outcome measure is the presence of delayed ischemic deficits. Secondary outcome measures include modified Rankin Disability Score at 3 months and cost-effectiveness analysis.

EXPECTED OUTCOMES: This will be the first study to clarify whether high-dose simvastatin is better than normal-dose simvastatin for patients with acute aneurysmal subarachnoid hemorrhage in terms of neurological outcomes and cost-effectiveness.

DISCUSSION: In the present trial, we compare high-dose and normal-dose simvastatin; we know that another ongoing phase III multicenter trial (Simvastatin in Aneurysmal Subarachnoid Haemorrhage; http://www.stashtrial.com/home.html) is comparing normal-dose and no simvastatin. When the results are interpreted together, the research question of a possible beneficial effect of high-dose simvastatin in acute aneurysmal subarachnoid hemorrhage could be answered.

ABBREVIATIONS: DID, delayed ischemic deficit

CBF, cerebral blood flow

SAH, subarachnoid hemorrhage

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