Statin Use in Abdominal Aortic Aneurysm Repair
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).
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2005
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 3, 2010
CompletedFirst Posted
Study publicly available on registry
February 4, 2010
CompletedFebruary 25, 2021
December 1, 2007
3.4 years
February 3, 2010
February 22, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The primary outcome measure was the level of MMP-9 in aortic wall samples of patients on statins and placebo.
Sample obtained at time of operation
Secondary Outcomes (1)
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.
Sample obtained at time of operation
Study Arms (2)
Placebo
PLACEBO COMPARATORStatin group
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Patient with an AAA \>5.5cm diameter listed for open AAA repair at least 3 weeks from screening attendance.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hull & east Yorkshire Hospitals NHS Trust
Hull, HU3 2JZ, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ian C Chetter, MBChB, FRCS
Hull Royal Infirmary, Hull, United Kingdom.
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2010
First Posted
February 4, 2010
Study Start
January 1, 2005
Primary Completion
June 1, 2008
Study Completion
December 1, 2008
Last Updated
February 25, 2021
Record last verified: 2007-12