NCT01077206

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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
255

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 1, 2010

Completed
6 months until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

2.8 years

First QC Date

February 26, 2010

Last Update Submit

February 2, 2015

Conditions

Subarachnoid Hemorrhage

Keywords

Aneurysmstatinsubarachnoid hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Presence of delayed ischemic neurological deficit

    One month

Secondary Outcomes (3)

  • Liver function derangement or rhabdomyolysis

    Three months

  • Modified Rankin Scale

    Three months

  • Cost-effectiveness analysis

    Three months

Study Arms (2)

Simvastatin 80mg

ACTIVE COMPARATOR
Drug: Simvastatin

Simvastatin 40mg

ACTIVE COMPARATOR
Drug: Simvastatin

Interventions

SimvastatinDRUG

80mg daily versus 40mg daily, for 21 days.

Also known as: Teva
Simvastatin 40mgSimvastatin 80mg

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, China

Location

Related Publications (2)

  • Wong GK, Chan DY, Siu DY, Zee BC, Poon WS, Chan MT, Gin T, Leung M; HDS-SAH Investigators. High-dose simvastatin for aneurysmal subarachnoid hemorrhage: multicenter randomized controlled double-blinded clinical trial. Stroke. 2015 Feb;46(2):382-8. doi: 10.1161/STROKEAHA.114.007006. Epub 2014 Dec 16.

    PMID: 25516195DERIVED

  • 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.

    PMID: 23392270DERIVED

MeSH Terms

Conditions

Subarachnoid HemorrhageAneurysm

Interventions

Simvastatin

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

LovastatinNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • George KC Wong

    Department of Surgery, The Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor (Clinical)

Study Record Dates

First Submitted

February 26, 2010

First Posted

March 1, 2010

Study Start

September 1, 2010

Primary Completion

June 1, 2013

Study Completion

September 1, 2013

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

CN(1)