Statin Use in Abdominal Aortic Aneurysm Repair

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Aneurysm formation is associated with a chronic inflammatory response, depletion of smooth muscle cell population and excessive matrix metalloproteinases (MMPs) production. 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statins) are lipid lowering agents with pleiotropic effects including anti-inflammatory activity. Elective open AAA repair patients will be randomised to receive either statin (Atorvastatin 80 mg) or placebo (dummy tablet) for 4 weeks pre-operatively. Tissue samples will be obtained from patient's aneurysm to assess MMP's and their inhibitors TIMP's. It is hypothesized that patients receiving statin will have reduced MMP's.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Hull
• Treatments: Atorvastatin; Atorvastatin Calcium

Criteria

Inclusion Criteria:

• Patient with an AAA >5.5cm diameter listed for open AAA repair at least 3 weeks from screening attendance.

Exclusion Criteria:

• Patients already on statin,

• inability to provide informed written consent,

• contraindication to statin (intrinsic liver disease,

• chronic alcohol abuse, impaired renal function, unstable hypothyroidism,

• unexplained muscle aches, hypersensitivity to atorvastatin or any of its components),

• previous unilateral or bilateral lower limb amputation and concomitant use of fibrates,

• erythromycin,

• immunosuppressive drugs,

• antifungal drugs or lipid lowering drugs.