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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28808

Enrollment

Registered

2006-04-21

Start date

2006-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

aneurysmal subarachnoid hemorrhage

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

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.

Design outcomes

Primary

Measure	Time frame
1. 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

Measure	Time frame
1. 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.	—

Measure

Time frame

1. 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.

—

Contacts

Public ContactM.D.I. Vergouwen

Academic Medical Center (AMC), Departement of Neurology H2, P.O. Box 22660

m.d.vergouwen@amc.uva.nl+31 (0)20 5663842

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)