Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)

The Washington University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Subarachnoid Hemorrhage

Treatments: Drug: Simvastatin, 80 mg/day for 21 days; Drug: placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT00795288

3857 - 54118B

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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42 participants in 2 patient groups, including a placebo group

Simvastatin, 80 mg/day

Experimental group

Description:

Simvastatin, 80 mg/day for 21 days

Treatment:

Drug: Simvastatin, 80 mg/day for 21 days

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo