Statin Use in Abdominal Aortic Aneurysm Repair
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01062802 |
Recruitment Status
:
Completed
First Posted
: February 4, 2010
Last Update Posted
: February 4, 2010
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Abdominal Aortic Aneurysm | Drug: Atorvastatin Other: Placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, 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). |
Study Start Date : | January 2005 |
Actual Primary Completion Date : | June 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
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.
|
- 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 ]
- 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 ]

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, Learn About Clinical Studies.
Ages Eligible for Study: | 20 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01062802
United Kingdom | |
Hull & east Yorkshire Hospitals NHS Trust | |
Hull, United Kingdom, HU3 2JZ |
Principal Investigator: | Ian C Chetter, MBChB, FRCS | Hull Royal Infirmary, Hull, United Kingdom. |
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 |
First Posted: | February 4, 2010 Key Record Dates |
Last Update Posted: | February 4, 2010 |
Last Verified: | December 2007 |
Additional relevant MeSH terms:
Aneurysm Aortic Aneurysm Aortic Aneurysm, Abdominal Vascular Diseases Cardiovascular Diseases Aortic Diseases Atorvastatin Calcium |
Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Enzyme Inhibitors |