Abdominal Aortic AneurysmPhase 2AARDVARKNCT01118520

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

A Phase 2 study testing perindopril arginine and amlodipine 5mgs in people with Abdominal Aortic Aneurysm, run by Imperial College London at 9 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 55 years and older
Conditions the study is for: Abdominal Aortic Aneurysm
What is being tested?: perindopril arginine and amlodipine 5mgs
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 224 participants
Where: 9 sitesUnited Kingdom
Study dates: Sep 2011to Apr 2015
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United Kingdom9 sites

The Royal Bournemouth and Christchurch Hospitals NHS Foundation Trust
Bournemouth, BH7 7DW
Colchester Hospital
Colchester, CO4 5JL
University Hospital Coventry and Warwickshire
Coventry, CV2 2DX
Hull Royal Infirmary
Hull, HU3 2JZ
Royal Free Hospital
London, NW3 2QG
St Thomas' Hospital
London, SE1 7EH
St Mary's Hospital, Imperial College Healthcare NHS Trust
London, W21PG
Charing Cross Hospital, Imperial College NHS Trust
London, W6 8RF
Freeman Hospital
Newcastle, NE7 7DN

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

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.

Conditions: Abdominal Aortic Aneurysm
Being tested: perindopril arginine, amlodipine 5mgs, placebo
Keywords: abdominal aortic aneurysm, ACE Inhibition
Medical subject headings: Aortic Aneurysm, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

perindopril arginineDrug
Also called coversyl arginine
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

Study groups in NCT01118520
Study group	Role	What they receive
perindopril	Active comparator	ACE inhibitor blood pressure lowering agent Receives: Drug: perindopril arginine
amlodipine	Active comparator	calcium channel blocker blood pressure lowering agent Receives: Drug: amlodipine 5mgs
placebo	Placebo comparator	inactive substance identical in appearance to the othe two comparators Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Annual rate over the entire period of 24 month

Secondary outcomes (1)

Number of Participants With Aneurysm Related Death
Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2011Apr 2015

First posted6 May 2010 (estimated)
Study startSep 2011
Primary completionApr 2015
Study completionApr 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Abdominal Aortic AneurysmStudies of the same condition, open and under way.
More trials run by Imperial College LondonThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 224 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01118520
Sponsor's protocol ID: CRO1644
Other IDs: 2010-020226-17, 08/109/02
Acronym: AARDVARK
Status last verified: Jan 2021
First submitted: 5 May 2010
Last updated: 26 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
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Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
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Not yet recruitingObservational study
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Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
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Enrolling by invitation
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All Abdominal Aortic Aneurysm trials

Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Evaluation of the Effect of an Angiotensin-converting Enzyme (ACE) Inhibitor on the Growth Rate of Small Abdominal Aortic Aneurysms.
ClinicalTrials.gov ID: NCT01118520
Acronym / sponsor ID: AARDVARK / CRO1644
Conditions: Abdominal Aortic Aneurysm
Keywords: abdominal aortic aneurysm, ACE Inhibition
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 224 participants (actual)
Lead sponsor: Imperial College LondonUniversity, hospital or other
Collaborators: National Institute for Health Research, United Kingdom
Study start: Sep 2011 (actual)
Primary completion: Apr 2015 (actual)
Study completion: Apr 2015 (actual)
First posted: 6 May 2010 (estimated)
Results: Posted 26 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

An ultrasound scan is a painless test that uses sound waves to create images of organs and structures inside your body.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
perindopril	Active comparator	Drug: perindopril arginineACE inhibitor blood pressure lowering agent
amlodipine	Active comparator	Drug: amlodipine 5mgscalcium channel blocker blood pressure lowering agent
placebo	Placebo comparator	Drug: placeboinactive substance identical in appearance to the othe two comparators

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
perindopril arginineAlso: coversyl arginine10mgs orally daily for the duration of the trial	Drug	perindopril
amlodipine 5mgs5 mgs taken orally daily for the duration of the trial	Drug	amlodipine
placeboone daily	Drug	placebo

Primary outcome

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).

1 secondary outcome

Number of Participants With Aneurysm Related Death
Time frame: 24 months

Results and safety

Results posted to the registry on 26 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Perindopril	73	53
Amlodipine	72	49
Placebo	79	59

Primary outcome: Change in the Growth Rate of Abdominal Aortic Aneurysm

Time frame: Annual rate over the entire period of 24 month. Least squares mean (Standard Error). Unit: mm

Measure	Perindopril n = 73	Amlodipine n = 72	Placebo n = 79
Value	1.77 (0.02)	1.81 (0.02)	1.66 (0.02)

Perindopril vs Placebo: p = 0.78, Mixed Models Analysis
Perindopril vs Amlodipine: p = 0.89, Mixed Models Analysis

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 24 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Perindopril	19 of 73 (26%)	7 of 73 (9.6%)	2 of 73
Amlodipine	12 of 72 (16.7%)	8 of 72 (11.1%)	2 of 72
Placebo	16 of 79 (20.3%)	9 of 79 (11.4%)	3 of 79

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Abdominal Aortic Aneurysm

Not yet recruitingObservational study
Pilot Study on the Effectiveness and Safety of OPTILENE® SILVER MESH ELASTIC in Prevention of Surgical Site Infection (SSI) and Incisional Hernia (IH)
Abdominal Aortic Aneurysm, Morbid Obesity
RecruitingPhase 4
Effect of Remimazolam Versus Propofol Total Intravenous Anesthesia on Intraoperative Hemodynamic Stability in Patients Undergoing Thoracic or Abdominal Endovascular Aortic Repair
Aortic Aneurysm, Thoracoabdominal, Aortic Aneurysm, Abdominal
Not yet recruitingObservational study
Aortic Size and Height Indices in Abdominal Aortic Aneurysms
Abdominal Aortic Aneurysm, Abdominal Aortic Aneurysm, Ruptured
Not yet recruitingObservational study
Real-World Data Collection of GORE Devices Used In the Endovascular Treatment of Aortic Aneurysms Which Incorporate Visceral Arteries.
Complex Aortic Aneurysms, Thoracoabdominal Aneurysm
Enrolling by invitation
Endovascular Treatment of Thoracic Aortic Disease
Thoracic Aortic Aneurysms, Dissecting, Aneurysm

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Janet Powell, MD study director

Imperial College London

Colin Bicknell, FRCS study director

Imperial College London

Deborah Ashby, PhD study director

Imperial College London

9 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing perindopril arginine and amlodipine 5mgs in people with Abdominal Aortic Aneurysm, run by Imperial College London at 9 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the Growth Rate of Abdominal Aortic Aneurysm (time frame: Annual rate over the entire period of 24 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01118520.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2021.