Condition category
Nervous System Diseases
Date applied
29/06/2006
Date assigned
29/06/2006
Last edited
02/09/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr M.D.I. Vergouwen

ORCID ID

Contact details

Academisch Medisch Centrum
Afdeling Neurologie H2
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
+31 (0)20 5663842
m.d.vergouwen@amc.uva.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR668

Study information

Scientific title

Acronym

Study hypothesis

In patients with aneurysmal subarachnoid hemorrhage (SAH), simvastatin restores endothelial cell damage, activates fibrinolysis, and improves coagulation and inflammation after the hemorrhage.

Ethics approval

Received from local medical ethics committee

Study design

Randomised doube blind placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Aneurysmal subarachnoid hemorrhage

Intervention

Patients will receive simvastatin 80 mg a day or placebo until day 14 after aneurysmal subarachnoid hemorrhage.

Intervention type

Drug

Phase

Not Specified

Drug names

Simvastatin

Primary outcome measures

1. The effects of simvastatin on the parameters of fibrinolysis, coagulation, inflammation and endothelial function after SAH
2. The relation between changes in fibrinolytic activity and endothelial cell damage and activation

Secondary outcome measures

1. The occurrence of cerebral ischemia after SAH
2. Outcome on the Glasgow Outcome Scale and Academic Medical Center Linear Disability Scale (ALDS) three and six months after subarachnoid hemorrhage
3. The relation between vasospasm as observed on transcranial Doppler examination and parameters of fibrinolysis, coagulation, endothelium dysfunction and inflammation
4. The relationship between cerebral ischemia as observed on perfusion CT-scans and
parameters of fibrinolysis, coagulation, endothelium dysfunction and inflammation
5. The relationship between plasminogen activator inhibitor type-1(PAI-1) polymorphism and fibrinolysis in patients treated with simvastatin and placebo
6. The relationship of polymorphisms in the endothelin system on endothelial cell damage
7. Differences in cerebral microcirculation between patients treated with placebo and
simvastatin

Overall trial start date

01/05/2006

Overall trial end date

01/11/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with clinical symptoms and signs of SAH with an aneurysmal bleeding pattern on the initial computerised tomography (CT) scan. CT scan has to be performed within 48 hours after SAH onset
2. Patients with a perimesencephalic hemorrhage pattern on the initial CT scan while computed tomographic angiography (CTA) or conventional angiography has shown an appropriate aneurysm. CTA or angiography has to be performed within 48 hours after SAH onset
3. If CT scan is negative while there is evidence of bleeding in the cerebrospinal fluid (xanthochromia) and the CT-angiography has shown an aneurysm

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

30

Participant exclusion criteria

1. Under 18 years of age
2. A time lapse of more than 48 hours after SAH onset
3. Patients using aspirin or warfarin
4. Patients already using statins
5. Contra-indication for simvastatin (active liver disease, liver transaminase more than three times the normal upper limit, myopathy)
6. Kidney insufficiency
7. If death appears imminent
8. Pregnancy or lactation

Recruitment start date

01/05/2006

Recruitment end date

01/11/2007

Locations

Countries of recruitment

Netherlands

Trial participating centre

Academisch Medisch Centrum
Amsterdam
1105 AZ
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (The Netherlands)

Sponsor details

Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

Academic Medical Centre (AMC) (Netherlands) - Department of Neurology

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19458605

Publication citations

  1. Results

    Vergouwen MD, Meijers JC, Geskus RB, Coert BA, Horn J, Stroes ES, van der Poll T, Vermeulen M, Roos YB, Biologic effects of simvastatin in patients with aneurysmal subarachnoid hemorrhage: a double-blind, placebo-controlled randomized trial., J. Cereb. Blood Flow Metab., 2009, 29, 8, 1444-1453, doi: 10.1038/jcbfm.2009.59.

Additional files

Editorial Notes