Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

Completed

Phase 1/2 Results

Trial Description

The primary objective of this project is to investigate the effect of statin therapy on cerebral blood flow in patients with aneurysmal SAH who are randomized to receive or not receive statins in a blinded design.

Detailed Description

We will determine if statin therapy improves CBF in patients with aneurysmal subarachnoid hemorrhage. This improvement, if present, may be due to improved basal CBF, improved autoregulatory function, or a mitigation of large arterial narrowing. The information gain from this study will help us to better understand the mechanism of action of statins. This knowledge may be useful in the design of future studies with statins and in the development of other therapies aimed at similar mechanisms.

Conditions

Interventions

  • Simvastatin Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol
  • Placebo Drug
    Intervention Desc: Control group
    ARM 1: Kind: Experimental
    Label: 2
    ARM 2: Kind: Experimental
    Label: Placebo
    Description: Placebo
  • Simvastatin, 80 mg/day for 21 days Drug
    Other Names: Simvastatin
    Intervention Desc: Active treatment group
    ARM 1: Kind: Experimental
    Label: 1
    Description: Simvastatin, 80 mg/day
    ARM 2: Kind: Experimental
    Label: Simvastatin, 80 mg/day
    Description: Simvastatin, 80 mg/day for 21 days

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients will be randomized to either placebo or Simvastatin 80 mg for 21 days. Follow-up will measure resting cerebral blood flow during peak period of vasospasm risk.

Outcomes

Type Measure Time Frame Safety Issue
Primary Resting cerebral blood flow during peak period of vasospasm risk; Cerebral autoregulation during peak period of vasospasm risk.
Secondary Impact of statin on oxygen extraction fraction and cerebral metabolism during peak period of vasospasm risk.
Primary Resting cerebral blood flow during peak period of vasospasm risk 7-10 days after hemorrhage No
Primary Cerebral autoregulation during peak period of vasospasm risk 7-10 days after hemorrhage Yes
Secondary Impact of statin on oxygen extraction fraction and cerebral metabolism during peak period of vasospasm risk 7-10 days after hemorrhage No

Sponsors