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ISRCTN
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ISRCTN45662651
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ClinicalTrials.gov identifier
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Public title
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Effect of simvastatin on endothelial dysfunction, fibrinolysis, coagulation and inflammation after aneurysmal subarachnoid hemorrhage
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Scientific title
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Acronym
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N/A
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Serial number at source
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NTR668
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Study hypothesis
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In patients with aneurysmal subarachnoid hemorrhage (SAH), simvastatin restores endothelial cell damage, activates fibrinolysis, and improves coagulation and inflammation after the hemorrhage.
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Ethics approval
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Received from local medical ethics committee
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Study design
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Randomised doube blind placebo controlled parallel group trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Aneurysmal subarachnoid hemorrhage
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/05/2006
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Anticipated end date
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01/11/2007
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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30
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Interventions
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Patients will receive simvastatin 80 mg a day or placebo until day 14 after aneurysmal subarachnoid hemorrhage.
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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Academic Medical Centre (AMC) (Netherlands) - Department of Neurology
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Trial website
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Publications
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2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19458605
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Contact name
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Dr
M.D.I.
Vergouwen
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Address
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Academisch Medisch Centrum
Afdeling Neurologie H2
Meibergdreef 9
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City/town
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Amsterdam
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Zip/Postcode
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1105 AZ
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Country
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Netherlands
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Tel
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+31 (0)20 5663842
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Fax
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+31 (0)20 6971438
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Email
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m.d.vergouwen@amc.uva.nl
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Sponsor
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Academic Medical Centre (AMC) (The Netherlands)
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Address
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Department of Neurology
P.O. Box 22660
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City/town
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Amsterdam
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Zip/Postcode
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1100 DD
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Country
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Netherlands
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Date applied
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29/06/2006
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Last edited
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02/09/2009
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Date ISRCTN assigned
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29/06/2006
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