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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
  Purpose

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).


Condition Intervention Phase
Subarachnoid Haemorrhage Drug: placebo Drug: simvastatin Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Simvastatin in Aneurysmal Subarachnoid Haemorrhage (STASH) a Multicentre Randomised Controlled Clinical Trial

Resource links provided by NLM:


Further study details as provided by Mr PJ Kirkpatrick, Cambridge University Hospitals NHS Foundation Trust:

Primary Outcome Measures:
  • Modified Rankin Disability Score (mRS) at 6 months [ Time Frame: 6-12 months ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 803
Study Start Date: January 2007
Study Completion Date: February 2014
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
placebo
Drug: placebo
one tablet a day for up to 21 days
Other Name: placebo tablet
Active Comparator: 11
simvastatin
Drug: simvastatin
simvastatin 40mg once a day for a maximum of 21 days
Other Name: ritechol

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731627


Locations
United States, Florida
Dept of Neurological Surgery, University of Florida
Gainesville, Florida, United States, 32610
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
British Heart Foundation
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mr PJ Kirkpatrick, Consultant Neurosurgeon, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT00731627     History of Changes
Other Study ID Numbers: 2006-000277-30
ISRCTN75948817
First Submitted: August 7, 2008
First Posted: August 11, 2008
Last Update Posted: June 25, 2014
Last Verified: June 2014

Keywords provided by Mr PJ Kirkpatrick, Cambridge University Hospitals NHS Foundation Trust:
intracranial aneurysm

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Intracranial Hemorrhages
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Enzyme Inhibitors