High-dose Simvastatin for Aneurysmal Subarachnoid Haemorrhage (HDS-SAH)
This study is ongoing, but not recruiting participants.
Sponsor:
Chinese University of Hong Kong
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: April 22, 2013
Last verified: April 2013
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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:
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 ]
| Estimated Enrollment: | 240 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | March 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
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
| 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: | April 22, 2013 |
| 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 Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013