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Effect of simvastatin on endothelial dysfunction, fibrinolysis, coagulation and inflammation after aneurysmal subarachnoid hemorrhage.


- candidate number2066
- NTR NumberNTR668
- ISRCTNISRCTN45662651
- Date ISRCTN created29-jun-2006
- date ISRCTN requested13-jun-2006
- Date Registered NTR21-apr-2006
- Secondary IDsN/A 
- Public TitleEffect of simvastatin on endothelial dysfunction, fibrinolysis, coagulation and inflammation after aneurysmal subarachnoid hemorrhage.
- Scientific TitleEffect of simvastatin on endothelial dysfunction, fibrinolysis, coagulation and inflammation after aneurysmal subarachnoid hemorrhage.
- ACRONYMN/A
- hypothesisIn patients with aneurysmal subarachnoid hemorrhage simvastatin restores endothelial cell damage, activates fibrinolysis, and improves coagulation and inflammation after the hemorrhage.
- Healt Condition(s) or Problem(s) studiedAneurysmal subarachnoid hemorrhage
- Inclusion criteria1. Patients with clinical symptoms and signs of SAH with an aneurysmal bleeding pattern on the initial 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 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2006
- planned closingdate1-nov-2007
- Target number of participants30
- InterventionsPatients will receive simvastatin 80 mg a day or placebo until day 14 after aneurysmal subarachnoid hemorrhage.
- Primary outcome1. The effects of simvastatin on 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 outcome1. The occurrence of cerebral ischemia after SAH;
2. Outcome on the Glasgow Outcome Scale and AMC Linear Disability Scale (ALDS) 3 and 6 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 relation between cerebral ischemia as observed on perfusion CT-scans and parameters of fibrinolysis, coagulation, endothelium dysfunction and inflammation;
5. The relation of PAI-1 polymorphism on fibrinolysis in patients treated with simvastatin and placebo;
6. The relation of polymorphisms in the endothelin system on endothelial cell damage;
7. Differences in cerebral microcirculation between patients treated with placebo and simvastatin.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESMD. M.D.I. Vergouwen
- CONTACT for SCIENTIFIC QUERIESMD. PhD. Y.B.W.E.M. Roos
- Sponsor/Initiator Academic Medical Center (AMC), Department of Neurology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Neurology
- PublicationsN/A
- Brief summaryRecently it has been observed that statins decrease the incidence of cerebral ischemia and vasospasm in patients with aneurysmal subarachnoid hemorrhage. This prospective, randomized, double-blind, placebo-controlled trial is an exploratory study designed to investigate the biological effects of simvastatin in patients with aneurysmal subarachnoid hemorrhage.
- Main changes (audit trail)
- RECORD21-apr-2006 - 13-jan-2010


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