CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 224 enrolled
Drug / intervention
perindopril arginine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01118520
NCT01118520Phase 2Completed

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

Imperial College London·interventional·Posted May 6, 2010·Updated Jan 26, 2021

In Brief

A Phase 2 clinical trial evaluating perindopril arginine, amlodipine 5mgs, and 1 other intervention for Abdominal Aortic Aneurysm. Completed, enrolled 224 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 6, 2010
Enrollment StartSep 1, 2011
Primary CompletionApr 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 16.2 years ago

Interventions

perindopril argininedrug

10mgs orally daily for the duration of the trial

amlodipine 5mgsdrug

5 mgs taken orally daily for the duration of the trial

placebodrug

one daily