Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial

Subarachnoid Haemorrhage Clinical Trial

— STASH  

Official title:

Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731627
• Other study ID #: 2006-000277-30
• Secondary ID: ISRCTN75948817
• Status: Completed
• Phase: Phase 3
• First received: August 7, 2008
• Last updated: June 24, 2014
• Start date: January 2007
• Est. completion date: February 2014

Study information

• Verified date: June 2014
• Source: Cambridge University Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 803
• Est. completion date: February 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Subarachnoid Haemorrhage
• Subarachnoid Hemorrhage

Intervention

Drug:
• placebo
one tablet a day for up to 21 days
• simvastatin
simvastatin 40mg once a day for a maximum of 21 days

Locations

Country	Name	City	State
United States	Dept of Neurological Surgery, University of Florida	Gainesville	Florida
United States	Mayo Clinic	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Cambridge University Hospitals NHS Foundation Trust	British Heart Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Modified Rankin Disability Score (mRS) at 6 months		6-12 months
Secondary	Need and intensity of delayed ischaemic deficit rescue therapy		1-3 months
Secondary	Incidence and duration of delayed ischaemic deficits		1-3 months
Secondary	Incidence and severity of sepsis		1-3 months
Secondary	Length of intensive care and total acute hospital stay		1-3 months
Secondary	Discharge destination		1-3 months