No registrations found.
ID
Source
Brief title
Health condition
Abdominal Aortic Aneurysm
Sponsors and support
Intervention
Outcome measures
Primary outcome
Aneurysm wall MCP-1, IL6 and 8 levels.
Secondary outcome
Aneurysm wall cell content, proteases and inflammatory transcription factors.
Background summary
In 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.
Study objective
We 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.
Study design
Time of elective aneurysm repair.
Intervention
80 mg Simvastatin started at least 2 weeks prior to the planned open aneurysm repair.
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Dpt. of Vascular Surgery.<br>
PO-box 9600
Jan H. Lindeman
Leiden 2300 RC
The Netherlands
Lindeman@lumc.nl
Inclusion criteria
1. Abdominal aortic aneurysm;
2. Current statin use.
Exclusion criteria
1. Liver dysfunction;
2. Excessive alcohol consumption.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL1702 |
NTR-old | NTR1812 |
Other | MEC LUMC : P09.005 |
ISRCTN | ISRCTN wordt niet meer aangevraagd |