Effect of simvastatin on endothelial dysfunction, fibrinolysis, coagulation and inflammation after aneurysmal subarachnoid hemorrhage
| ISRCTN | ISRCTN45662651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45662651 |
| Secondary identifying numbers | NTR668 |
- Submission date
- 29/06/2006
- Registration date
- 29/06/2006
- Last edited
- 02/09/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr M.D.I. Vergouwen
Scientific
Scientific
Academisch Medisch Centrum
Afdeling Neurologie H2
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
| Phone | +31 (0)20 5663842 |
|---|---|
| m.d.vergouwen@amc.uva.nl |
Study information
| Study design | Randomised doube blind placebo controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | In patients with aneurysmal subarachnoid hemorrhage (SAH), simvastatin restores endothelial cell damage, activates fibrinolysis, and improves coagulation and inflammation after the hemorrhage. |
| Ethics approval(s) | Received from local medical ethics committee |
| Health condition(s) or problem(s) studied | Aneurysmal subarachnoid hemorrhage |
| Intervention | Patients will receive simvastatin 80 mg a day or placebo until day 14 after aneurysmal subarachnoid hemorrhage. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Simvastatin |
| Primary outcome measure | 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 study start date | 01/05/2006 |
| Completion date | 01/11/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 30 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/05/2006 |
| Date of final enrolment | 01/11/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academisch Medisch Centrum
Amsterdam
1105 AZ
Netherlands
1105 AZ
Netherlands
Sponsor information
Academic Medical Centre (AMC) (The Netherlands)
University/education
University/education
Department of Neurology
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
|---|
Funders
Funder type
University/education
Academic Medical Centre (AMC) (Netherlands) - Department of Neurology
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2009 | Yes | No |
