Status:
COMPLETED
Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial
Lead Sponsor:
Cambridge University Hospitals NHS Foundation Trust
Collaborating Sponsors:
British Heart Foundation
Conditions:
Subarachnoid Haemorrhage
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
803 Patients enrolled
Trial Details
Trial ID
NCT00731627
Start Date
January 1 2007
End Date
February 1 2014
Last Update
June 25 2014
Active Locations (2)
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1
Dept of Neurological Surgery, University of Florida
Gainesville, Florida, United States, 32610
2
Mayo Clinic
Jacksonville, Florida, United States, 32224