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


- candidate number5741
- NTR NumberNTR1812
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-mei-2009
- Secondary IDsP09.005 MEC LUMC
- Public TitleThe effect of high dose statin therapy (Simvastatin 80 mg) on vascular inflammation in the aortic abdominal aneurysm.
- Scientific TitleThe effect of high dose statin therapy (Simvastatin 80 mg) on vascular inflammation in the aortic abdominal aneurysm.
- ACRONYMSPITFIRE II
- hypothesisWe hypothese that the anti-inflammatory effects of statin therapy are dose dependent, and that the effects of high dose statin therapy on vascular inflammation are superior to standard dose statin therapy.
- Healt Condition(s) or Problem(s) studiedAbdominal Aortic Aneurysm
- Inclusion criteria1. Abdominal aortic aneurysm;
2. Current statin use.
- Exclusion criteria1. Liver dysfunction;
2. Excessive alcohol consumption.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-jul-2009
- planned closingdate1-mrt-2010
- Target number of participants25
- Interventions80 mg Simvastatin started at least 2 weeks prior to the planned open aneurysm repair.
- Primary outcomeAneurysm wall MCP-1, IL6 and 8 levels.
- Secondary outcomeAneurysm wall cell content, proteases and inflammatory transcription factors.
- TimepointsTime of elective aneurysm repair.
- Trial web siteN/A
- statusplanned
- 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 summaryIn this trial we aim to confirm preclinical evidence that statins, independent of their lipid lowering effects, reduce vascular inflammation. The study will be performed in the abdominal aortic aneurysm, a condition that is part of the atherosclerotic spectrum and that is not primarily cholesterol driven. As there is evidence that the anti-inflammatory effects of statins are dose dependent we now propose to study whether high dose statin therapy is superior to the effects of standard dose statin (samples already available). To study putative anti-inflammatory effects, patients awaiting open elective aneurysm repair will be asked to take Simvastatin 80 mg/day in the weeks prior to operation. Aneurysm wall samples will be collected at the time of operation and the effects of high dose Simvastatin will be evaluated by comparison with control samples of patients on standard dose Simvastatin/Atorvastatin (20 or 40 mg/day) or no statin.
- Main changes (audit trail)
- RECORD13-mei-2009 - 30-sep-2009


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