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The effect of high dose statins (Simvastatin 80 mg) on vascular inflammation in the abdominal aneurysm.


- candidate number8223
- NTR NumberNTR2410
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-jul-2010
- Secondary IDsP10.085 / NL24354.058.09 ; MEC LUMC / CCMO
- Public TitleThe effect of high dose statins (Simvastatin 80 mg) on vascular inflammation in the abdominal aneurysm.
- Scientific TitleHet effect van hoog gedoseerde statine-therapie (simvastatine, 80 mg) op de ontstekingsactiviteit in het abdominale aneurysma.
- ACRONYMSPITFIRE II
- hypothesisIndependently of their lipid lowering effects statins have been shown to quench markers of vascular inflammation. In an observational study we observed a mild but dose dependent anti -inflammatory effect of intermediate dose statins on vascular inflammation. As of these observations we now propose to test the hypothesis that high dose statins have a clinically relevant effect on vascular inflammation in the abdominal aortic aneurysm.
- Healt Condition(s) or Problem(s) studiedAbdominal Aortic Aneurysm
- Inclusion criteria1. Age >18;
2. Open elective AAA repair;
3. Current statin use.
- Exclusion criteria1. Statin intolerance;
2. Renal impairment (clearance <30 ml/min);
3. Liver impairment;
4. Excess alcohol consumption;
5. Any chronic inflammatory conditions;
6. Use of one or more of the following pharmaceutical agents: Itraconazol, Ketoconazol, Erytromycine, Claritromycine, Ciclosporine, Fibrates, immuo suppressives or HIV-protease inhibitors;
7. Inflammatory aneurysm.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeintervention
- planned startdate 15-jul-2010
- planned closingdate31-dec-2011
- Target number of participants25
- InterventionsSimvastatin 80 mg OID.
- Primary outcomeAortic wall IL6, IL8 and MCP-1 levels.
- Secondary outcome1. Aortic wall cell counts;
2. Aortic wall protease expression;
3. Aortic wall transcription factor activation.
- TimepointsMinimal treatment period 2 weeks prior to the surgery.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD, PhD Jan H. Lindeman
- CONTACT for SCIENTIFIC QUERIESMD, PhD Jan H. Lindeman
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
Leiden University Medical Center (LUMC)
- PublicationsN/A
- Brief summaryN/A
- Main changes (audit trail)
- RECORD8-jul-2010 - 27-jul-2010


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