Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage

Terminated

Phase N/A Results

Trial Description

The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.

Detailed Description

Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10 per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing of the blood vessels (vasospasm) and related delayed strokes are the most common serious complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke. Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH, this critically important issue needs further studies.
One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80 mg per mouth daily), while the control group will receive a sugar tablet. The treatment will be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures, these are included with the application for your review) at day 21 post aSAH will be reviewed at time of discharge as well at 6 months of follow up.

Trial Stopped: Study PI left the institution and study was stopped at that time.

Conditions

Interventions

  • Simvastatin Drug
    Intervention Desc: Comparing two doses of Simvastatin to placebo
    ARM 1: Kind: Experimental
    Label: Study Group #1
    Description: Simvastatin 40 mg
    ARM 2: Kind: Experimental
    Label: Study Group #2
    Description: Simvastatin 80 mg
  • Placebo Drug
    Intervention Desc: Placebo tablet
    ARM 1: Kind: Experimental
    Label: Control Group
    Description: Placebo tablet
  • Simvastatin 80 mg Drug
    Intervention Desc: Comparing two doses of Simvastatin to placebo
    ARM 1: Kind: Experimental
    Label: Study Group #2
    Description: Simvastatin 80 mg
  • Simvastatin 40 mg Drug
    Other Names: Zocor
    Intervention Desc: Comparing two doses of Simvastatin to placebo
    ARM 1: Kind: Experimental
    Label: Study Group #1
    Description: Simvastatin 40 mg

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Investigator)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized after being diagnosed with SAH via CT to either placebo or Simvastatin. Patients will have neurological outcome determined by accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at day 21 post aSAH. Patients will be followed for 6 months to determine incidence of clinical vasospasm.

Outcomes

Type Measure Time Frame Safety Issue
Primary To measure outcome in patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH) treated with Simvastatin, by assessing neurological outcome by accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at day 21 post aSAH.
Secondary To determine efficiency of Simvastatin in decreasing the incidence of clinical vasospasm in aSAH, and define the optimal dose of Simvastatin and to measure outcome at 6 months follow up.
Primary To measure outcome in patients diagnosed with aneurysmal subarachnoid hemorrhage (aSAH) treated with Simvastatin, by assessing neurological outcome by accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at day 21 post aSAH 21 days No
Secondary To determine efficiency of Simvastatin in decreasing the incidence of clinical vasospasm in aSAH, and define the optimal dose of Simvastatin and to measure outcome at 6 months follow up 6 months No

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