We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00731627
First Posted: August 11, 2008
Last Update Posted: June 25, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
British Heart Foundation
Information provided by (Responsible Party):
Mr PJ Kirkpatrick, Cambridge University Hospitals NHS Foundation Trust
August 7, 2008
August 11, 2008
June 25, 2014
January 2007
September 2013   (Final data collection date for primary outcome measure)
Modified Rankin Disability Score (mRS) at 6 months [ Time Frame: 6-12 months ]
Modified Rankin Disability Score (mRS) at 6 months [ Time Frame: at 6months post ictus ]
Complete list of historical versions of study NCT00731627 on ClinicalTrials.gov Archive Site
  • Need and intensity of delayed ischaemic deficit rescue therapy [ Time Frame: 1-3 months ]
  • Incidence and duration of delayed ischaemic deficits [ Time Frame: 1-3 months ]
  • Incidence and severity of sepsis [ Time Frame: 1-3 months ]
  • Length of intensive care and total acute hospital stay [ Time Frame: 1-3 months ]
  • Discharge destination [ Time Frame: 1-3 months ]
  • Need and intensity of delayed ischaemic deficit rescue therapy [ Time Frame: during in-patient stay ]
  • Incidence and duration of delayed ischaemic deficits [ Time Frame: during in-patient stay ]
  • Incidence and severity of sepsis [ Time Frame: during ip-patient stay ]
  • Length of intensive care and total acute hospital stay [ Time Frame: during ip-patient stay ]
  • Discharge destination [ Time Frame: on discharge from hospital ]
Not Provided
Not Provided
 
Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial
Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial

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).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Subarachnoid Haemorrhage
  • Drug: placebo
    one tablet a day for up to 21 days
    Other Name: placebo tablet
  • Drug: simvastatin
    simvastatin 40mg once a day for a maximum of 21 days
    Other Name: ritechol
  • Placebo Comparator: 1
    placebo
    Intervention: Drug: placebo
  • Active Comparator: 11
    simvastatin
    Intervention: Drug: simvastatin
Budohoski KP, Czosnyka M, Kirkpatrick PJ. The Role of Monitoring Cerebral Autoregulation After Subarachnoid Hemorrhage. Neurosurgery. 2015 Aug;62 Suppl 1:180-4. doi: 10.1227/NEU.0000000000000808.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
803
February 2014
September 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00731627
2006-000277-30
ISRCTN75948817
Yes
Not Provided
Not Provided
Mr PJ Kirkpatrick, Cambridge University Hospitals NHS Foundation Trust
Cambridge University Hospitals NHS Foundation Trust
British Heart Foundation
Not Provided
Cambridge University Hospitals NHS Foundation Trust
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP