Evaluation of Effect of Angiotensin-converting Enzyme (ACE) Inhibitors on Small Aneurysm Growth Rate
Information source: Imperial College London
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Abdominal Aortic Aneurysm
Intervention: perindopril arginine (Drug); amlodipine 5mgs (Drug); placebo (Drug)
Phase: Phase 2
Sponsored by: Imperial College London
Official(s) and/or principal investigator(s):
Janet Powell, MD, Principal Investigator, Affiliation: Imperial College Charing Cross
Colin Bucknell, MD, Principal Investigator, Affiliation: Imperial Colege St Marys
deborah Ashby, PhD, Study Director, Affiliation: Imperial college. Faculty of Medicine statistics
Meryl E davis, FRCS, Principal Investigator, Affiliation: Royal Free Hospital NHS Trust
Mathew M Thompson, MD, Principal Investigator, Affiliation: St Georges Hospital Medical School
Mathew Waltham, Principal Investigator, Affiliation: Guys Hospital NHS trust
Neil Poulter, FRCP, Study Director, Affiliation: Imperial Clinical Trials Unit
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
An ultrasound scan is a painless test that uses sound waves to create images of organs and
structures inside your body.
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Primary outcome: Reduction growth rate of abdominal aortic aneurysm
Secondary outcome: effect of treatment with perindopril on aneurysm related death rates
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.
Minimum age: 55 Years.
Maximum age: N/A.
- All men or women, aged 60-85 years, with AAA <5. 5 cm and with a systolic BP < 150
mmHg will be eligible for inclusion in the trial. For patients whose systolic BP is >
150 mmHg, treatment will be initiated with a diuretic Indapamide SR 1. 5mgs by the
principal investigator and/or amlodipine (5 mg daily) initiated by the general
Practitioner. If the SBP subsequently falls to < 150 mmHg on this medication subjects
would then be eligible for inclusion into the study.
- Patients already receiving an ACE-inhibitor or amlodipine 10mg daily.
- Patients with known renal artery stenosis (> 50%).
- Patients who cannot be converted to diuretic therapy and/or lower doses of
- Those unable to give informed consent and those too frail to travel for 3-monthly
Locations and Contacts
University Hospital Coventry and Warwickshire, Coventry CV2 2DX, United Kingdom
Charing Cross Hospital, Imperial College NHS Trust, London W6 8RF, United Kingdom
Royal Free Hospital, London NW3 2QG, United Kingdom
St Mary's Hospital, Imperial College Healthcare NHS Trust, London W21PG, United Kingdom
St Thomas' Hospital, London SE1 7EH, United Kingdom
Starting date: September 2011
Last updated: August 4, 2015