Condition category
Circulatory System
Date applied
15/02/2006
Date assigned
04/04/2006
Last edited
12/08/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
A blood vessel abnormality called an aneurysm can cause a bleed within the head. We wish to study the potential benefits of giving a standard cholesterol lowering drug (called Simvastatin) after a bleed has occurred. This is a licensed medication used regularly in the treatment for other vascular conditions including heart attacks and strokes, but it is not licensed at this stage for the treatment of a bleed in the brain. In some instances we may also wish to find out whether the patient’s genetic makeup can influence the course of your disease, its clinical outcome, or response to the medicine that we are testing.

Who can participate?
Patients aged 18 – 65years in whom the admitting neurosurgeon has diagnosed a bleed onto the surface of the brain, called a subarachnoid haemorrhage (SAH). We propose to recruit approximately 800 people to the trial.

What does the study involve?
Patients will be allocated randomly (like a flip of the coin) to taking either Simvastatin 40mg or an inactive “dummy” drug called a placebo. The treatment will be administered as one tablet daily for up to 21 days. If the patient is discharged from the Neurosurgical Unit before 21 days, treatment will be stopped. Nobody (not even the doctors) will know which treatment is being given until the study is over. However, if necessary, the doctor will be able to find out which treatment has been given if any concern arises. Before they leave the hospital we will assess the patient’s level of recovery. Two short questionnaires will be sent to their home 6 months later asking about their current level of recovery and state of health.

What are the possible benefits and risks of participating?
In the event of taking Simvastatin we hope that this drug might help in recovery. However, this cannot be guaranteed. More likely, the information we obtain from this study may help us to improve on the treatment for future patients suffering from SAH.
Possible rare side effects of Simvastatin include muscle weakness or tenderness, headache, nausea or rash. However no regular side effects have been observed even in patients receiving this treatment for many years. However, in the event of any serious unforeseen reactions, or if any concerns arise, the drug will be stopped immediately.

Where is the study run from?
Department of Neurosurgery, Cambridge University Hospitals NHS Foundation Trust

When is the study starting and how long is it expected to run for?
The study started in May 2006 and is expected to end in January 2014.

Who is funding the study?
British Heart Foundation

Who is the main contact?
Mr Peter J Kirkpatrick
pjk21@medschl.cam.ac.uk

Trial website

http://www.stashtrial.com

Contact information

Type

Scientific

Primary contact

Mr Peter Kirkpatrick

ORCID ID

Contact details

Box 167
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Additional identifiers

EudraCT number

2006-000277-30

ClinicalTrials.gov number

NCT00731627

Protocol/serial number

STASH01

Study information

Scientific title

Acronym

STASH

Study hypothesis

Can acute statin therapy reduce the incidence and duration of delayed ischaemic deficits following a subarachnoid haemorrhage (SAH)?

On 04/12/2012 the anticipated end date was changed from 01/05/2009 to 31/01/2014.

Ethics approval

Thames Valley Research Ethics Committee, 06/07/2006, ref: 06/MRE12/26

Study design

Multi-centre double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

http://www.stashtrial.com/downloads.html

Condition

Subarachnoid haemorrhage

Intervention

Simvastatin versus placebo

Intervention type

Drug

Phase

Phase III

Drug names

Simvastatin

Primary outcome measures

Clinical outcome at six months

Secondary outcome measures

1. Short form questionnaire (SF-36) scores at six months
2. Incidence and duration of delayed ischaemic deficits
3. Need and intensity of delayed ischaemic deficits rescue therapy
4. Incidence of extracranial organ dysfunction and failure
5. Incidence and duration of extracranial organ support
6. Incidence and severity of sepsis
7. Length of intensive care and total acute hospital stay
8. Percentage of patients being discharged directly home
9. Reduction in intensive care requirements for those with sepsis

Overall trial start date

01/05/2006

Overall trial end date

31/01/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients aged 18-65 years
2. If the admitting neurosurgeon has a high index of suspicion of a spontaneous aneurysmal subarachnoid haemorrhage (good clinical history with convincing computerised tomography [CT] findings)
3. Any clinical grade accepted provided there is a reasonable prospect of survival
4. Delay to randomisation and initiation of trial medication, from the time of the presenting bleed, does not exceed 96 hours
5. Independent prior to the SAH

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Unsalvageable patients: fixed and dilated pupils after resuscitation, and/or a devastating scan, which precludes definitive therapy
2. Already taking statin therapy
3. Those taking warfarin-type drugs
4. Pregnancy
5. Known renal or hepatic impairment
6. Suspected or known additional disease process, which threatens life expectancy (e.g. malignancy)
7. Known or strong suspicion of drug abuse, alcoholism, or those who are unlikely to be amenable to six-month follow up

Recruitment start date

01/05/2006

Recruitment end date

31/01/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Box 167
Cambridge
CB2 2QQ
United Kingdom

Sponsor information

Organisation

Cambridge University Hospitals NHS Foundation Trust (UK)

Sponsor details

Box 146
Addenbrooke's Hospital
Hills Road
Cambridge
CB2 2QQ
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Charity

Funder name

British Heart Foundaton (BHF) (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24837690

Publication citations

  1. Results

    Kirkpatrick PJ, Turner CL, Smith C, Hutchinson PJ, Murray GD, , Simvastatin in aneurysmal subarachnoid haemorrhage (STASH): a multicentre randomised phase 3 trial., Lancet Neurol, 2014, 13, 7, 666-675, doi: 10.1016/S1474-4422(14)70084-5.

Additional files

Editorial Notes