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

NCT01118520 | Completed Phase 2 Results DMC

• 3 other identifiers: CRO16442010-020226-1708/109/02
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Abdominal Aortic Aneurysm

Keywords

abdominal aortic aneurysm; ACE Inhibition

Outcome Measures

Primary Outcomes (1)

• Change in the Growth Rate of Abdominal Aortic Aneurysm

  Aneurysm growth rate over 2 years, estimated from the sequential AAA diameter measurements (external diameter measured in the longitudinal plane).

  Annual rate over the entire period of 24 month

Secondary Outcomes (1)

• Number of Participants With Aneurysm Related Death

  24 months

Study Arms (3)

perindopril

ACTIVE COMPARATOR

ACE inhibitor blood pressure lowering agent

Drug: perindopril arginine

amlodipine

ACTIVE COMPARATOR

calcium channel blocker blood pressure lowering agent

Drug: amlodipine 5mgs

placebo

PLACEBO COMPARATOR

inactive substance identical in appearance to the othe two comparators

Drug: placebo

Interventions

perindopril arginine DRUG

10mgs orally daily for the duration of the trial

Also known as: coversyl arginine

perindopril

amlodipine 5mgs DRUG

5 mgs taken orally daily for the duration of the trial

amlodipine

placebo DRUG

one daily

placebo

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \<150mmHg (unless they require and are already receiving an ACE-inhibitor or amlodipine 10mg daily).

You may not qualify if:

• Patients who are already required to take either an ACE-inhibitor or a calcium channel blocker or Angiotensin II blocker (ARB) who cannot be converted to diuretic therapy and/ora 5mg dose of amlodipine for control (ie SBP \< 150mmHg) of their BP.
• Those with known renal artery stenosis (\>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.

Sponsors & Collaborators

• Imperial College London: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (9)

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

Bournemouth, BH7 7DW, United Kingdom

Location

Colchester Hospital

Colchester, CO4 5JL, United Kingdom

Location

University Hospital Coventry and Warwickshire

Coventry, CV2 2DX, United Kingdom

Location

Hull Royal Infirmary

Hull, HU3 2JZ, United Kingdom

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

St Mary's Hospital, Imperial College Healthcare NHS Trust

London, W21PG, United Kingdom

Location

Charing Cross Hospital, Imperial College NHS Trust

London, W6 8RF, United Kingdom

Location

Freeman Hospital

Newcastle, NE7 7DN, United Kingdom

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

Viacoram

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Results Point of Contact

• Title: Professor Neil Poulter
• Organization: Imperial College London

n.poulter@imperial.ac.uk

+44(0) 20 7594 3446

Study Officials

• Janet Powell, MD

  Imperial College London

  STUDY DIRECTOR

• Colin Bicknell, FRCS

  Imperial College London

  STUDY DIRECTOR

• Deborah Ashby, PhD

  Imperial College London

  STUDY DIRECTOR

• Meryl E Davis, FRCS

  Royal Free Hospital NHS Trust

  PRINCIPAL INVESTIGATOR

• Mathew Waltham, FRCS

  Guys Hospital NHS trust

  PRINCIPAL INVESTIGATOR

• Neil Poulter, FRCP

  Imperial College London

  STUDY DIRECTOR

• Christopher Imray, FRCS

  University Hospitals Coventry & Warwickshire

  PRINCIPAL INVESTIGATOR

• Dynesh Rittoo, FRCS

  The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Ian Chetter, FRCS

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

• Sohail Choksy, FRCS

  East Suffolk and North Essex NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Tim Lees, FRCS

  The Newcastle Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Andrew Thompson, FRCS

  York Teaching Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Vince Smyth, FRCS

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Shah Nawaz, FRCS

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Andrew Brown, FRCS

  City Hospitals Sunderland NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Felicity Meyer, FRCS

  Norfolk and Norwich University Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2010
• First Posted: May 6, 2010
• Study Start: September 1, 2011
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 26, 2021
• Results First Posted: January 26, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (9)