Fenofibrate in the Management of Abdominal Aortic Aneurysms 2

Phase 4

Completed

• Conditions: Abdominal Aortic Aneurysm; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12613001039774
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-09-18
• Study Completion: 2016-04-22
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Ability to provide written informed consent.
Diagnosis of an asymptomatic abdominal aortic aneurysm which is infrarenal in location and 35-49mm in size.
High likelihood of medication compliance.

Exclusion Criteria

Current use of any fenofibrate or related fibrates contra-indication to fenofibrate including; liver impairment demonstrated by abnormal liver function tests (greater than or equal to 1.5 times normal upper limit); renal impairment (serum creatinine greater than or equal to
150 micromole); symptomatic gallbladder disease; previous reaction to any lipid modifying medication.
Previous aortic surgery
A Mycotic, symptomatic, ruptured or infected abdominal aortic aneurysm
A requirement for emergency or urgent open abdominal aortic aneurysm repair
Current enrolment in any other drug trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum OPN concentration. This will be assessed on stored serum using the Quantikine R&D Systems ELISA according to manufactuer's instructions.[24 weeks post commencement of drug/placebo.];Serum kallistatin concentration (ng/ml). This will be assessed on stored serum using the Quantikine R&D Systems ELISA according to the manufacturer's instructions. <br>[24 weeks post commencement of drug/placebo]

Secondary Outcome Measures

Name	Time	Method
Serum resistin concentration. This will be measured using ELISA (R&D Systems) according to the manufacturer's instructions and expressed as nanogram per milliliter. [24 weeks post commencement of drug/placebo.];Serum lipids, including total cholesterol, triglycerides, LDL and HDL. These will be assessed on serum obtained from patients who have fasted overnight using automated assays.[24 weeks post commencement of drug/placebo.];Plasma MMP-9. The concentration of MMP-9 will be measured using an ELISA from R&D Systems.[24 weeks post commencement of drug/placebo.];Other markers of inflammation including full blood count, c-reactive protein, cell markers for T cells, B cells and neutrophils using automated assays and flow cytometry. [24 weeks post commencement of drug/placebo.];Abdominal aortic aneurysm diameter. This will be assessed by an ultrasound of the abdominal aorta.[24 weeks post commencement of drug/placebo.]