NCT01118520: AARDVARK

An Evaluation of the Effect of an Angiotensin-converting Enzyme (ACE) Inhibitor on the Growth Rate of Small Abdominal Aortic Aneurysms.

Completed Phase 2 Results posted Last updated 5 January 2021

What this trial tests

Phase 2 trial testing perindopril arginine in Abdominal Aortic Aneurysm in 224 participants. Completed in 1 April 2015.

Timeline

1 September 2011

Primary endpoint
1 April 2015

1 April 2015

Quick facts

Lead sponsor	Imperial College London
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	224
Start date	1 September 2011
Primary completion	1 April 2015
Estimated completion	1 April 2015
Sites	9 locations across United Kingdom

Drugs / interventions tested

• perindopril arginine (PERINDOPRIL ARGININE) — full drug profile →
• amlodipine 5mgs — full drug profile →
• placebo

Conditions studied

• Abdominal Aortic Aneurysm — all drugs for Abdominal Aortic Aneurysm →

Sponsor

Imperial College London

Who can join

55 and older, any sex, with Abdominal Aortic Aneurysm. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Change in the Growth Rate of Abdominal Aortic Aneurysm
  Time frame: Annual rate over the entire period of 24 month
  Aneurysm growth rate over 2 years, estimated from the sequential AAA diameter measurements (external diameter measured in the longitudinal plane).

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Abdominal aortic aneurysm: novel mechanisms and therapies.
   Davis FM, Rateri DL, Daugherty A. · · 2015 · cited 126× · PMID 26352243 · DOI 10.1097/hco.0000000000000216
2. Angiotensin-converting enzyme 2 decreases formation and severity of angiotensin II-induced abdominal aortic aneurysms.
   Thatcher SE, Zhang X, Howatt DA, Yiannikouris F, et al · · 2014 · cited 45× · PMID 25301841 · DOI 10.1161/atvbaha.114.304613
3. ACE inhibitors potently reduce vascular inflammation, results of an open proof-of-concept study in the abdominal aortic aneurysm.
   Kortekaas KE, Meijer CA, Hinnen JW, Dalman RL, et al · · 2014 · cited 43× · PMID 25474105 · DOI 10.1371/journal.pone.0111952
4. Medical treatment for small abdominal aortic aneurysms.
   Rughani G, Robertson L, Clarke M. · · 2012 · cited 41× · PMID 22972146 · DOI 10.1002/14651858.cd009536.pub2
5. Development of pharmacotherapies for abdominal aortic aneurysms.
   Weaver LM, Loftin CD, Zhan CG. · · 2022 · cited 24× · PMID 35780618 · DOI 10.1016/j.biopha.2022.113340
6. Recent Advances in Nanomedicine-Mediated Abdominal Aortic Aneurysm Treatment.
   Lu X, Hu Q. · · 2025 · cited 5× · PMID 40384281 · DOI 10.1002/smtd.202402268