View Clinical Trial (Medical Research Study)
Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial
| City: |
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Gainesville |
| State: |
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Florida |
| Zip Code: |
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32610 |
| Conditions: |
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Subarachnoid Haemorrhage |
| Purpose: |
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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).
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| Study Summary: |
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| Criteria: |
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Inclusion Criteria
- Patients (age 18 - 65 yr) in which the admitting neurosurgeon has confirmatory
evidence of an aneurysm, either by CT angiography, MR angiography or DSA.
- Any clinical grade accepted provided a reasonable prospect of survival.
- Delay to randomisation and initiation of trial medication from the time of the
presenting ictus does not exceed 96 hours.
Exclusion Criteria
- Unsalvageable patients:Fixed and dilated pupils after resuscitation, and/or a
devastating scan, which precludes definitive therapy.
- Already taking statin therapy.
- Those taking Warfarin - type drugs.
- Pregnancy.
- Known renal or hepatic impairment
- Suspected or known additional disease process, which threatens life expectancy
(e.g.malignancy).
- Known or strong suspicion of drug abuse, alcoholism, or those who are unlikely to be
amenable to 6 month follow up.
- Those already taking amiodarone, verapamil or potent CYP3A4 inhibitors.
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| NCT ID: |
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NCT00731627 |
| Primary Contact: |
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Peter J Kirkpatrick, FRCS
Phone: +44 1223 217214
Email: pjk21@medschl.cam.ac.uk
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| Backup Contact: |
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Email: clt29@medschl.cam.ac.uk
Carole L Turner, MSc
Phone: +44 1223 217205
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| Location Contact: |
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Gainesville, Florida 32610
United States
Stephen Lewis, FRACS
Phone: 352-273-9000
Email: stephen.lewis@neurosurgery.ufl.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 18, 2013 |
| Modifications to this listing: |
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