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High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage (HDS-SAH)

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. Identifier: NCT01077206
Recruitment Status : Completed
First Posted : March 1, 2010
Last Update Posted : February 4, 2015
Hong Kong Government
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong

Brief Summary:

Experimental evidences supported the benefit of Simvastatin in subarachnoid haemorrhage. Moreover, Simvastatin is a potent agent in achieving low-density lipoprotein (LDL) reduction with a proven safety profile. However, there is no clinical data to compare the efficacy of different dosage regimens (namely whether high-dose regimen is better) and related cost-effectiveness analysis, although biochemical actions and related neuroprotective mechanisms were thought to be dosage-related. This gap in knowledge is important, on how to implement the use of statin and interpret different trial results. With these in mind, the investigators designed the current study.


Daily Simvastatin 80mg (high dose) treatment given within 96 hours of the ictus over three weeks will reduce incidence and duration of delayed ischemic deficits following subarachnoid haemorrhage when compared to daily Simvastatin 40mg (normal dose) treatment, leading to improvement in clinical outcome, which translates into advantage in terms of cost-effectiveness.

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Drug: Simvastatin Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 255 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage: Is it Better?
Study Start Date : September 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Simvastatin

Arm Intervention/treatment
Active Comparator: Simvastatin 80mg Drug: Simvastatin
80mg daily versus 40mg daily, for 21 days.
Other Name: Teva

Active Comparator: Simvastatin 40mg Drug: Simvastatin
80mg daily versus 40mg daily, for 21 days.
Other Name: Teva

Primary Outcome Measures :
  1. Presence of delayed ischemic neurological deficit [ Time Frame: One month ]

Secondary Outcome Measures :
  1. Liver function derangement or rhabdomyolysis [ Time Frame: Three months ]
  2. Modified Rankin Scale [ Time Frame: Three months ]
  3. Cost-effectiveness analysis [ Time Frame: Three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Patients (age 18-70 years) in which the admitting neurosurgeon has a high index of suspicion of a spontaneous aneurysmal subarachnoid haemorrhage with a convincing CT scan findings.
  2. Any clinical grade accepted provided a reasonable prospect of survival.
  3. Delay to randomization and initiation of trial medication from the time of the presenting ictus does not exceed 96 hours.

Exclusion criteria:

  1. Unsalvageable patients: Fixed and dilated pupils after resuscitation, and/or a devastating scan, which preludes 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 likely to be amendable to 3 month follow up.
  8. Those already taking amiodarone, verapamil or potent CYP3A4 inhibitors.

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 identifier (NCT number): NCT01077206

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The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Hong Kong Government
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Principal Investigator: George KC Wong Department of Surgery, The Chinese University of Hong Kong
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: George KC Wong, Professor (Clinical), Chinese University of Hong Kong Identifier: NCT01077206    
Other Study ID Numbers: GW005
First Posted: March 1, 2010    Key Record Dates
Last Update Posted: February 4, 2015
Last Verified: February 2015
Keywords provided by George KC Wong, Chinese University of Hong Kong:
subarachnoid hemorrhage
Additional relevant MeSH terms:
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Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors