Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial
- Registration Number
- NCT00731627
- Brief Summary
Intracranial bleeding from ruptured blood vessels (called a subarachnoid haemorrhage -SAH) affects 7000 patients each year in the UK and is a source of considerable death and disability, even in young adults. Recent observations indicate that these bleeds can cause reduced cerebral blood flow which leads to a bad outcome. High rates of death and disability occur, and are particularly prevalent when low cerebral blood flow results in stroke. Prevention of cerebral artery spasm and improvement in blood vessel reflexes are the target of modern therapy. Candidate drugs include statins which have an impeccable safety record and multiple potential beneficial actions (improve cerebral blood flow, reduce inflammatory processes, reduce adverse blood coagulation) following SAH.
The investigators plan to use a statin, Simvastatin (40 mg) to improve cerebral blood flow and reduce inflammation. We have already completed a phase 11 study (n=80) which demonstrated potential benefits for acute statin therapy following SAH, and the investigators now wish to conduct a multi-centre phase 111 study to explore any potential clinical benefits in a larger population (n=1600). The purpose is to see whether the positive effects of statins seen in our phase II study translate into clinical benefits - both short term (e.g. reduced need for intensive care) and long term (outcome and wellbeing at 6 months).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 803
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 placebo placebo 11 simvastatin simvastatin
- Primary Outcome Measures
Name Time Method Modified Rankin Disability Score (mRS) at 6 months 6-12 months
- Secondary Outcome Measures
Name Time Method Need and intensity of delayed ischaemic deficit rescue therapy 1-3 months Incidence and duration of delayed ischaemic deficits 1-3 months Incidence and severity of sepsis 1-3 months Length of intensive care and total acute hospital stay 1-3 months Discharge destination 1-3 months
Trial Locations
- Locations (2)
Dept of Neurological Surgery, University of Florida
🇺🇸Gainesville, Florida, United States
Mayo Clinic
🇺🇸Jacksonville, Florida, United States