drugset / Trial / NCT01077206

High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage

NCT01077206

RandomizedParallel-groupTriple-blindPrevention

Summary

Experimental evidences supported the benefit of Simvastatin in subarachnoid haemorrhage. Moreover, Simvastatin is a potent agent in achieving low-density lipoprotein (LDL) reduction with a proven safety profile. However, there is no clinical data to compare the efficacy of different dosage regimens (namely whether high-dose regimen is better) and related cost-effectiveness analysis, although biochemical actions and related neuroprotective mechanisms were thought to be dosage-related. This gap in knowledge is important, on how to implement the use of statin and interpret different trial results. With these in mind, the investigators designed the current study. Hypothesis: Daily Simvastatin 80mg (high dose) treatment given within 96 hours of the ictus over three weeks will reduce incidence and duration of delayed ischemic deficits following subarachnoid haemorrhage when compared to daily Simvastatin 40mg (normal dose) treatment, leading to improvement in clinical outcome, which translates into advantage in terms of cost-effectiveness.

Timeline

Start
2010-09
Primary completion
2013-06
Completion
2013-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Simvastatin Small molecule 40 mg Oral
Comparator Simvastatin Small molecule 80 mg Oral