Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Text Size

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

This study has been completed.
Sponsor:
Collaborator:
Hong Kong Government
Information provided by (Responsible Party):
George KC Wong, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT01077206
First received: February 26, 2010
Last updated: February 2, 2015
Last verified: February 2015
History of Changes
  Purpose

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.

Hypothesis:

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 Intervention Phase
Subarachnoid Hemorrhage
 Drug: Simvastatin
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage: Is it Better?

Resource links provided by NLM:

MedlinePlus related topics: Bleeding
Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • Presence of delayed ischemic neurological deficit [ Time Frame: One month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver function derangement or rhabdomyolysis [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
  • Modified Rankin Scale [ Time Frame: Three months ] [ Designated as safety issue: Yes ]
  • Cost-effectiveness analysis [ Time Frame: Three months ] [ Designated as safety issue: No ]
Enrollment: 255
Study Start Date: September 2010
Study Completion Date: September 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01077206

Locations
China
The Chinese University of Hong Kong
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Hong Kong Government
Investigators
Principal Investigator: George KC Wong Department of Surgery, The Chinese University of Hong Kong
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: George KC Wong, Professor (Clinical), Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT01077206     History of Changes
Other Study ID Numbers: GW005 
Study First Received: February 26, 2010
Last Updated: February 2, 2015
Health Authority: Hong Kong: Joint CUHK-NTEC Clinical Research Ethics Committee

Keywords provided by Chinese University of Hong Kong:
Aneurysm
statin
subarachnoid hemorrhage

Additional relevant MeSH terms:
Hemorrhage
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
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
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 23, 2016