AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)
NCT ID: NCT01118520
Last Updated: 2021-01-26
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
224 participants
INTERVENTIONAL
2011-09-30
2015-04-30
Brief Summary
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There is a suggestion that the use of a specific drug class, angiotensin converting enzyme (ACE) inhibitors, may reduce the risk of rupture of the larger aneurysms. This trial will assess whether an ACE inhibitor (perindopril) has aneurysm-related benefits, in patients with small AAAs at screening centres in the London area.
The effects of perindopril versus a placebo(dummy) on AAA growth rates will be compared. In addition by comparing the effects of perindopril with the effects of equivalent blood pressure lowering with another non-ACE inhibitor class of drug (amlodipine) on aneurysm growth rate, we can see whether any benefits of perindopril are simply the result of lowering blood pressure. 225 Patients will be assigned to one of these 3 treatments by chance (randomisation).In addition to analysis of the effect of perindopril and blood pressure lowering,the effect of the treatments on quality of life will be assessed. Patients will return at 3-monthly intervals for an ultrasound scan and blood pressure measurements, with questionnaires regarding quality of life at the start and end of the 2-year research period.
An ultrasound scan is a painless test that uses sound waves to create images of organs and structures inside your body.
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Detailed Description
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Pending results of this pilot trial, we plan to work with the local and National Aneurysm Screening programme to conduct a larger, definitive trial, to investigate the hypothesis that blood pressure reduction with an ACE-inhibitor slows the rate of small AAA growth preferentially compared with other antihypertensive agents.
Secondary research questions in this trial are the effects of perindopril therapy on aneurysm-related death rates, other diseases possibly caused by an AAA and quality of life compared to similar blood pressure lowering effects with amlodipine and placebo.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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perindopril
ACE inhibitor blood pressure lowering agent
perindopril arginine
10mgs orally daily for the duration of the trial
amlodipine
calcium channel blocker blood pressure lowering agent
amlodipine 5mgs
5 mgs taken orally daily for the duration of the trial
placebo
inactive substance identical in appearance to the othe two comparators
placebo
one daily
Interventions
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perindopril arginine
10mgs orally daily for the duration of the trial
amlodipine 5mgs
5 mgs taken orally daily for the duration of the trial
placebo
one daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Men or women, aged at least 55 years
With AAA 3 to 5.4 cm in diameter by internal or external measurement according to ultrasound
A systolic BP \<150mmHg (unless they require and are already receiving an ACE-inhibitor or amlodipine 10mg daily).
Exclusion Criteria
Those with known renal artery stenosis (\>50%), or with a serum creatinine of \>180µmol/L
Those unable to give informed consent
Those too frail to travel for 3-monthly surveillance will be excluded
Any clinically significant medical condition which, in the opinion of the investigator, may interfere with the study results and or reduce life expectancy to \< 2 years
Participation in another trial of an investigational product or device within the previous 30 days
Known allergy or sensitivity to perindopril or amlodipine
Unable or unwilling to comply with the requirements of the study, in the opinion of the investigator.
55 Years
ALL
No
Sponsors
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National Institute for Health Research, United Kingdom
OTHER_GOV
Imperial College London
OTHER
Responsible Party
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Principal Investigators
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Janet Powell, MD
Role: STUDY_DIRECTOR
Imperial College London
Colin Bicknell, FRCS
Role: STUDY_DIRECTOR
Imperial College London
Deborah Ashby, PhD
Role: STUDY_DIRECTOR
Imperial College London
Meryl E Davis, FRCS
Role: PRINCIPAL_INVESTIGATOR
Royal Free Hospital NHS Trust
Mathew Waltham, FRCS
Role: PRINCIPAL_INVESTIGATOR
Guys Hospital NHS trust
Neil Poulter, FRCP
Role: STUDY_DIRECTOR
Imperial College London
Christopher Imray, FRCS
Role: PRINCIPAL_INVESTIGATOR
University Hospitals Coventry & Warwickshire
Dynesh Rittoo, FRCS
Role: PRINCIPAL_INVESTIGATOR
The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Ian Chetter, FRCS
Role: PRINCIPAL_INVESTIGATOR
Hull University Teaching Hospitals NHS Trust
Sohail Choksy, FRCS
Role: PRINCIPAL_INVESTIGATOR
East Suffolk and North Essex NHS Foundation Trust
Tim Lees, FRCS
Role: PRINCIPAL_INVESTIGATOR
The Newcastle Hospitals NHS Foundation Trust
Andrew Thompson, FRCS
Role: PRINCIPAL_INVESTIGATOR
York Teaching Hospital NHS Foundation Trust
Vince Smyth, FRCS
Role: PRINCIPAL_INVESTIGATOR
Manchester University NHS Foundation Trust
Shah Nawaz, FRCS
Role: PRINCIPAL_INVESTIGATOR
Sheffield Teaching Hospitals NHS Foundation Trust
Andrew Brown, FRCS
Role: PRINCIPAL_INVESTIGATOR
City Hospitals Sunderland NHS Foundation Trust
Felicity Meyer, FRCS
Role: PRINCIPAL_INVESTIGATOR
Norfolk and Norwich University Hospitals NHS Foundation Trust
Locations
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The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, , United Kingdom
Colchester Hospital
Colchester, , United Kingdom
University Hospital Coventry and Warwickshire
Coventry, , United Kingdom
Hull Royal Infirmary
Hull, , United Kingdom
Royal Free Hospital
London, , United Kingdom
St Thomas' Hospital
London, , United Kingdom
St Mary's Hospital, Imperial College Healthcare NHS Trust
London, , United Kingdom
Charing Cross Hospital, Imperial College NHS Trust
London, , United Kingdom
Freeman Hospital
Newcastle, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Other Identifiers
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2010-020226-17
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
08/109/02
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CRO1644
Identifier Type: -
Identifier Source: org_study_id
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