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Statin Use in Abdominal Aortic Aneurysm Repair

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
University of Hull
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Abdominal Aortic Aneurysm

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hull & east Yorkshire Hospitals NHS Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

Statin group

Arm Description

Outcomes

Primary Outcome Measures

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

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.

Full Information

First Posted
February 3, 2010
Last Updated
February 22, 2021
Sponsor
University of Hull
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1. Study Identification

Unique Protocol Identification Number
NCT01062802
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).
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Hull

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Statin group
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
Atorvastatin 80mg, once a day for four weeks.
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo given once daily for 4 weeks.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian C Chetter, MBChB, FRCS
Organizational Affiliation
Hull Royal Infirmary, Hull, United Kingdom.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hull & east Yorkshire Hospitals NHS Trust
City
Hull
ZIP/Postal Code
HU3 2JZ
Country
United Kingdom

12. IPD Sharing Statement

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Statin Use in Abdominal Aortic Aneurysm Repair

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