Statin Use in Abdominal Aortic Aneurysm Repair

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Statin Use in Abdominal Aortic Aneurysm Repair

Official Title

Randomised Controlled Trial of Effect of Pre-operative Statin Use on Matrix Metalloproteinases (MMP) & Tissue Inhibitors of Matrix Metalloproteinases (TIMP) in Abdominal Aortic Aneurysm (AAA).

Brief 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.

Detailed 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 Phase

Phase 4

Study Type

Interventional

Primary Outcome

The primary outcome measure was the level of MMP-9 in aortic wall samples of patients on statins and placebo.

Secondary Outcome

 The secondary outcome measures were the levels of MMP-2, MMP-8, TIMP-1, TIMP-2 and the variation in areas of peak wall stress due to statins.

Condition

Abdominal Aortic Aneurysm

Intervention

Atorvastatin

Study Arms / Comparison Groups

 Placebo
Description:

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

40

Start Date

January 2005

Completion Date

December 2008

Primary Completion Date

June 2008

Eligibility 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.

Gender

All

Ages

20 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ian C Chetter, MBChB, FRCS, ,

Location Countries

United Kingdom

Location Countries

United Kingdom

Administrative Informations

NCT ID

NCT01062802

Organization ID

CB/EL/R0135

Responsible Party

Sponsor

Study Sponsor

University of Hull

Study Sponsor

Ian C Chetter, MBChB, FRCS, Principal Investigator, Hull Royal Infirmary, Hull, United Kingdom.

Verification Date

December 2007