Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

Phase 1

Completed

• Conditions: Subarachnoid Hemorrhage
• Interventions: Drug: Simvastatin, 80 mg/day for 21 days; Drug: placebo

• Registration Number: NCT00795288
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Primary Completion: 2013-02
• Study Completion: 2013-12
• Results First Submitted: 2014-12-08
• Results First Submitted QC: 2015-01-07
• Results First Posted: 2015-01-16
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Age > 18
• SAH from ruptured cerebral aneurysm within 48 hours of admission.
• Modified Fisher grade 2,3,or 4
• Planned surgical or endovascular aneurysm repair

Exclusion Criteria

• Pregnancy
• SAH secondary to traumatic or mycotic aneurysms
• Pre-ictal statin therapy
• Contraindication to stain therapy
• WFNS grade 5
• Contraindications to MAP elevation on day 7-10

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simvastatin, 80 mg/day	Simvastatin, 80 mg/day for 21 days	Simvastatin, 80 mg/day for 21 days
Placebo	placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk	7-10 days after hemorrhage	Resting cerebral blood flow during peak period of vasospasm risk measured by PET
Cerebral Autoregulation During Peak Period of Vasospasm Risk	7-10 days after hemorrhage	Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) \* 100 A value of \<60 is considered abnormal.

Secondary Outcome Measures

Name	Time	Method
Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk	7-10 days after hemorrhage	Oxygen extraction fraction (OEF) is the ratio of Oxygen delivery (ml/100 g/min) and oxygen utilization (ml/100 g/min). It describes the fraction of the oxygen that reaches the brain that it actually uses for energy production.

Trial Locations

Locations (1)

Washington Univeristy; 🇺🇸 ST Louis, Missouri, United States