Evaluation of Effect of Angiotensin-converting Enzyme (ACE) Inhibitors on Small Aneurysm Growth Rate (AARDVARK)
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|ClinicalTrials.gov Identifier: NCT01118520|
Recruitment Status : Completed
First Posted : May 6, 2010
Last Update Posted : August 6, 2015
Abdominal aortic aneurysms (AAA) are balloon-like swellings of the body's main blood vessel (aorta) as it courses through the abdomen. As a result of the National Aneurysm Screening programme many more of these will be detected. Small AAAs grow slowly and remain a benign condition until the diameter exceeds 2-3 times the diameter of the normal aorta (about 5.5cm in size), when operative repair of the aneurysm is recommended avoiding the potentially fatal event of bursting and bleeding (aneurysm rupture). It is therefore important to identify a strategy to prevent aneurysm growth.
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.
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Drug: perindopril arginine Drug: amlodipine 5mgs Drug: placebo||Phase 2|
This trial will investigate the idea that an ACE-inhibitor reduces abdominal aortic aneurysm (AAA) growth rate, in a pilot 3-arm randomised controlled trial (i.e. the study treatment is chosen by random for each patient). The three interventions are ACE-inhibition with perindopril; equivalent blood pressure reduction with amlodipine (a calcium channel blocker) and a placebo tablet. By comparing the effects in the perindopril and amlodipine arms, this design will permit an evaluation of any blood pressure independent effects of perindopril.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||227 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||An Evaluation of the Effect of an Angiotensin-converting Enzyme (ACE) Inhibitor on the Growth Rate of Small Abdominal Aortic Aneurysms. A Double Blind Comparison With Similar Blood Pressure Lowering Medication (Calcium Channel Blockade)and Placebo|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Active Comparator: perindopril
ACE inhibitor blood pressure lowering agent
Drug: perindopril arginine
10mgs orally daily for the duration of the trial
Other Name: coversyl arginine
Active Comparator: amlodipine
calcium channel blocker blood pressure lowering agent
Drug: amlodipine 5mgs
5 mgs taken orally daily for the duration of the trial
Placebo Comparator: placebo
inactive substance identical in appearance to the othe two comparators
- Reduction growth rate of abdominal aortic aneurysm [ Time Frame: Every three months over a 2 year period ]This trial will investigate the idea that an ACE-inhibitor reduces abdominal aortic aneurysm (AAA) growth rate, in a pilot 3-arm randomised controlled trial (i.e. the study treatment is chosen by random for each patient). The three interventions are ACE-inhibition with perindopril; equivalent blood pressure reduction with amlodipine (a calcium channel blocker) and a placebo tablet. By comparing the effects in the perindopril and amlodipine arms, this design will permit an evaluation of any blood pressure independent effects of perindopril.
- effect of treatment with perindopril on aneurysm related death rates [ Time Frame: 42 months ]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.
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): NCT01118520
|University Hospital Coventry and Warwickshire|
|Coventry, United Kingdom, CV2 2DX|
|Royal Free Hospital|
|London, United Kingdom, NW3 2QG|
|St Thomas' Hospital|
|London, United Kingdom, SE1 7EH|
|St Mary's Hospital, Imperial College Healthcare NHS Trust|
|London, United Kingdom, W21PG|
|Charing Cross Hospital, Imperial College NHS Trust|
|London, United Kingdom, W6 8RF|
|Principal Investigator:||Janet Powell, MD||Imperial College Charing Cross|
|Principal Investigator:||Colin Bucknell, MD||Imperial Colege St Marys|
|Study Director:||deborah Ashby, PhD||Imperial college. Faculty of Medicine statistics|
|Principal Investigator:||Meryl E davis, FRCS||Royal Free Hospital NHS Trust|
|Principal Investigator:||Mathew M Thompson, MD||St Georges Hospital Medical School|
|Principal Investigator:||Mathew Waltham||Guys Hospital NHS trust|
|Study Director:||Neil Poulter, FRCP||Imperial College London|