Phase 2
N=42
Statins and Cerebral Blood Flow in Subarachnoid Hemorrhage (SAH)
Subarachnoid Hemorrhage
Bottom Line
View on ClinicalTrials.gov: NCT00795288 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk — .34; .30 mL/100 g/min
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Simvastatin, 80 mg/day for 21 days (Drug); placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Resting Cerebral Blood Flow During Peak Period of Vasospasm Risk |
.34; .30 | — |
| PRIMARY Cerebral Autoregulation During Peak Period of Vasospasm Risk |
2; 2 | — |
| SECONDARY Impact of Statin on Oxygen Extraction Fraction and Cerebral Metabolism During Peak Period of Vasospasm Risk |
.34; .3 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00795288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.