- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01062802
Statin Use in Abdominal Aortic Aneurysm Repair
February 22, 2021 updated by: University of Hull
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).
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Hull, United Kingdom, HU3 2JZ
- Hull & East Yorkshire Hospitals NHS Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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Placebo given once daily for 4 weeks.
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Active Comparator: Statin group
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Atorvastatin 80mg, once a day for four weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Sample obtained at time of operation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Sample obtained at time of operation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ian C Chetter, MBChB, FRCS, Hull Royal Infirmary, Hull, United Kingdom.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
June 1, 2008
Study Completion (Actual)
December 1, 2008
Study Registration Dates
First Submitted
February 3, 2010
First Submitted That Met QC Criteria
February 3, 2010
First Posted (Estimate)
February 4, 2010
Study Record Updates
Last Update Posted (Actual)
February 25, 2021
Last Update Submitted That Met QC Criteria
February 22, 2021
Last Verified
December 1, 2007
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Aortic Diseases
- Aneurysm
- Aortic Aneurysm
- Aortic Aneurysm, Abdominal
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antimetabolites
- Anticholesteremic Agents
- Hypolipidemic Agents
- Lipid Regulating Agents
- Hydroxymethylglutaryl-CoA Reductase Inhibitors
- Atorvastatin
Other Study ID Numbers
- CB/EL/R0135
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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