Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

Subarachnoid Hemorrhage Clinical Trial

Official title:

Effect of Statins on Cerebral Blood Flow After Subarachnoid Hemorrhage

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00795288
• Other study ID #: 3857 - 54118B
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 20, 2008
• Last updated: January 7, 2015
• Start date: August 2008
• Est. completion date: December 2013

Study information

• Verified date: January 2015
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• Simvastatin, 80 mg/day for 21 days
Active treatment group
• placebo
Control group

Locations

Country	Name	City	State
United States	Washington Univeristy	ST Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk	Resting cerebral blood flow during peak period of vasospasm risk measured by PET	7-10 days after hemorrhage	No
Primary	Cerebral Autoregulation During Peak Period of Vasospasm Risk	Fraction of patients with impaired static autoregulation (% change in MAP/% change in CVR) * 100 A value of <60 is considered abnormal.	7-10 days after hemorrhage	No
Secondary	Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk		7-10 days after hemorrhage	No