Statin Use in Abdominal Aortic Aneurysm Repair

Status Completed

Clinical Trial 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.

Clinical Trial Description

All patients listed for elective open AAA repair will be screened for suitability to participate within the study. In this double blind randomized control trial patients will be recruited through vascular surgical outpatient clinics. After inclusion, informed consent and evaluation of base line characteristics patients will be given a prescription for study medication. This prescription was exchanged by the patient for medication at the hospital pharmacy. Randomization will be carried out by pharmacy with computer generated sequence with a sub group size of 4. This will ascertain the order of prescribed drug/ placebo. Pharmacy then dispensed the drug/ placebo in this order. Drug used will be Atorvastatin 80 mg, white, elliptical, film coated tablets debossed '80' on one side and 'PD 158' on the other side. The placebo is similar in shape and colour. Drug/ placebo will be given for 4 weeks pre-operatively. Full thickness infrarenal aortic samples will obtained at time of operation and the exact sample site will be recorded. Samples will be washed with 0.9% saline to remove blood and clots, snap-frozen and stored at -80C for subsequent MMP 2, 8 and 9 and TIMP 1 and 2 analyses. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01062802
Study type	Interventional
Source	University of Hull
Contact
Status	Completed
Phase	Phase 4
Start date	January 2005
Completion date	December 2008

View Details

See also
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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.