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
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion criteria:

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.
Any clinical grade accepted provided a reasonable prospect of survival.
Delay to randomization 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 preludes 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 likely to be amendable to 3 month follow up.
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

No publications provided by Chinese University of Hong Kong

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

Wong GK, Liang M, Tan H, Lee MW, Po YC, Chan KY, Poon WS. High-dose simvastatin for aneurysmal subarachnoid hemorrhage: a multicenter, randomized, controlled, double-blind clinical trial protocol. Neurosurgery. 2013 May;72(5):840-4. doi: 10.1227/NEU.0b013e31828ab413.


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 Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Intracranial Hemorrhages Nervous System Diseases Pathologic Processes Vascular Diseases	Simvastatin Anticholesteremic Agents Antimetabolites Enzyme Inhibitors Hydroxymethylglutaryl-CoA Reductase Inhibitors Hypolipidemic Agents Lipid Regulating Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on March 03, 2015

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