Simvastatin After Aneurysmal Subarachnoid Hemorrhage

Completed

Phase N/A Results

Trial Description

To determine whether simvastatin reduces serum markers of brain injury and lessens vasospasm after SAH.

Interventions

  • Simvastatin Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol

Trial Design

Randomized, double-blind, placebo-controlled trial.

Patient Involvement

Patients with angiographically documented aneurysmal SAH were randomized within 48 hours of symptom onset to receive either simvastatin (80 mg daily; n=19) or placebo (n=20) for 14 days. Plasma alanine aminotransferase, aspartate aminotransferase, and creatine phosphokinase were recorded weekly to evaluate laboratory evidence of hepatitis or myositis. Serum markers of brain injury were recorded daily.

Outcomes

Type Measure Time Frame Safety Issue
Primary The primary end point of vasospasm was defined as clinical impression (delayed ischemic deficit not associated with rebleed, infection, or hydrocephalus) in the presence of >/=1 confirmatory radiographic test (angiography or transcranial Doppler demonstrating mean VMCA >160 m/sec).

Sponsors

NIH research grant R21NS4487-01 & Merck and Co, Inc. D.T.L