Phase 2 Completed N=224 Randomized Triple-blind Treatment

AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK)

Abdominal aortic aneurysm

Source: ClinicalTrials.gov NCT01118520 ↗

Enrolled (actual)

224

Serious AEs

21.0%

Results posted

Jan 2021

Primary outcomePrimary: Change in the Growth Rate of Abdominal Aortic Aneurysm — 1.77; 1.81; 1.66 mm — p=0.78

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in the Growth Rate of Abdominal Aortic Aneurysm	1.77; 1.81; 1.66	0.78
SECONDARY Number of Participants With Aneurysm Related Death	0; 0; 0	—

Eligibility Criteria

Inclusion criteria

Willing and able to give written informed consent

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 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01118520). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.