Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Statin Use in Abdominal Aortic Aneurysm Repair

This study has been completed.
Sponsor:
Information provided by:
University of Hull
ClinicalTrials.gov Identifier:
NCT01062802
First received: February 3, 2010
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Abdominal Aortic Aneurysm
Drug: Atorvastatin
Other: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
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).

Resource links provided by NLM:


Further study details as provided by University of Hull:

Primary Outcome Measures:
  • The primary outcome measure was the level of MMP-9 in aortic wall samples of patients on statins and placebo. [ Time Frame: Sample obtained at time of operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. [ Time Frame: Sample obtained at time of operation ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2005
Study Completion Date: December 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Other: Placebo
Placebo given once daily for 4 weeks.
Active Comparator: Statin group Drug: Atorvastatin
Atorvastatin 80mg, once a day for four weeks.

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01062802

Locations
United Kingdom
Hull & east Yorkshire Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Sponsors and Collaborators
University of Hull
Investigators
Principal Investigator: Ian C Chetter, MBChB, FRCS Hull Royal Infirmary, Hull, United Kingdom.
  More Information

No publications provided

Responsible Party: Prof. Peter McCollum, Hull Royal Infirmary, Hull, United Kingdom.
ClinicalTrials.gov Identifier: NCT01062802     History of Changes
Other Study ID Numbers: CB/EL/R0135
Study First Received: February 3, 2010
Last Updated: February 3, 2010
Health Authority: United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases
Atorvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014