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High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage

NCT01077206 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 255

Last updated 2015-02-04

No results posted yet for this study

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.

Conditions

  • Subarachnoid Hemorrhage

Interventions

DRUG

Simvastatin

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

Sponsors & Collaborators

  • Hong Kong Government

    collaborator OTHER_GOV

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • George KC Wong · Department of Surgery, The Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2013-06-30
Completion
2013-09-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01077206 on ClinicalTrials.gov