Trial Outcomes & Findings for AARDVARK (Aortic Aneurysmal Regression of Dilation: Value of ACE-Inhibition on RisK) (NCT NCT01118520)
NCT ID: NCT01118520
Last Updated: 2021-01-26
Results Overview
Aneurysm growth rate over 2 years, estimated from the sequential AAA diameter measurements (external diameter measured in the longitudinal plane).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
224 participants
Primary outcome timeframe
Annual rate over the entire period of 24 month
Results posted on
2021-01-26
Participant Flow
Participant milestones
| Measure |
Perindopril
10mgs orally daily for the duration of the trial
|
Amlodipine
5 mgs taken orally daily for the duration of the trial
|
Placebo
one daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
73
|
72
|
79
|
|
Overall Study
COMPLETED
|
53
|
49
|
59
|
|
Overall Study
NOT COMPLETED
|
20
|
23
|
20
|
Reasons for withdrawal
| Measure |
Perindopril
10mgs orally daily for the duration of the trial
|
Amlodipine
5 mgs taken orally daily for the duration of the trial
|
Placebo
one daily
|
|---|---|---|---|
|
Overall Study
AAA repair
|
9
|
7
|
9
|
|
Overall Study
Adverse Event
|
3
|
3
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
13
|
8
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Perindopril
n=73 Participants
10mgs orally daily for the duration of the trial
|
Amlodipine
n=72 Participants
5 mgs taken orally daily for the duration of the trial
|
Placebo
n=79 Participants
one daily
|
Total
n=224 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
71.6 years
STANDARD_DEVIATION 6.9 • n=73 Participants
|
71.5 years
STANDARD_DEVIATION 6.7 • n=72 Participants
|
70.7 years
STANDARD_DEVIATION 7.5 • n=79 Participants
|
71.2 years
STANDARD_DEVIATION 7.1 • n=224 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=73 Participants
|
6 Participants
n=72 Participants
|
5 Participants
n=79 Participants
|
13 Participants
n=224 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=73 Participants
|
66 Participants
n=72 Participants
|
74 Participants
n=79 Participants
|
211 Participants
n=224 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United Kingdom
|
73 participants
n=73 Participants
|
72 participants
n=72 Participants
|
79 participants
n=79 Participants
|
224 participants
n=224 Participants
|
|
Number of participants receiving statin treatment
|
53 Participants
n=73 Participants
|
45 Participants
n=72 Participants
|
48 Participants
n=79 Participants
|
146 Participants
n=224 Participants
|
|
Number of participants with diabetes
|
2 Participants
n=73 Participants
|
6 Participants
n=72 Participants
|
8 Participants
n=79 Participants
|
16 Participants
n=224 Participants
|
|
Systolic blood pressure
|
130.9 mmHg
STANDARD_DEVIATION 11.5 • n=73 Participants
|
131.9 mmHg
STANDARD_DEVIATION 13 • n=72 Participants
|
131.7 mmHg
STANDARD_DEVIATION 12.2 • n=79 Participants
|
131.5 mmHg
STANDARD_DEVIATION 12.2 • n=224 Participants
|
|
Diastolic blood pressure
|
76.7 mmHg
STANDARD_DEVIATION 8 • n=73 Participants
|
78.7 mmHg
STANDARD_DEVIATION 7 • n=72 Participants
|
77.9 mmHg
STANDARD_DEVIATION 7.6 • n=79 Participants
|
77.7 mmHg
STANDARD_DEVIATION 7.5 • n=224 Participants
|
|
Abdominal Aortic Aneurysm external longitudinal diameter
|
4.05 cm
STANDARD_DEVIATION 0.65 • n=73 Participants
|
4.03 cm
STANDARD_DEVIATION 0.69 • n=72 Participants
|
4.06 cm
STANDARD_DEVIATION 0.67 • n=79 Participants
|
4.05 cm
STANDARD_DEVIATION 0.67 • n=224 Participants
|
PRIMARY outcome
Timeframe: Annual rate over the entire period of 24 monthAneurysm growth rate over 2 years, estimated from the sequential AAA diameter measurements (external diameter measured in the longitudinal plane).
Outcome measures
| Measure |
Perindopril
n=73 Participants
10mgs orally daily for the duration of the trial
|
Amlodipine
n=72 Participants
5 mgs taken orally daily for the duration of the trial
|
Placebo
n=79 Participants
one daily
|
|---|---|---|---|
|
Change in the Growth Rate of Abdominal Aortic Aneurysm
|
1.77 mm
Standard Error 0.02
|
1.81 mm
Standard Error 0.02
|
1.66 mm
Standard Error 0.02
|
SECONDARY outcome
Timeframe: 24 monthsOutcome measures
| Measure |
Perindopril
n=73 Participants
10mgs orally daily for the duration of the trial
|
Amlodipine
n=72 Participants
5 mgs taken orally daily for the duration of the trial
|
Placebo
n=79 Participants
one daily
|
|---|---|---|---|
|
Number of Participants With Aneurysm Related Death
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Perindopril
Serious events: 19 serious events
Other events: 7 other events
Deaths: 2 deaths
Amlodipine
Serious events: 12 serious events
Other events: 8 other events
Deaths: 2 deaths
Placebo
Serious events: 16 serious events
Other events: 9 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Perindopril
n=73 participants at risk
10mgs orally daily for the duration of the trial
|
Amlodipine
n=72 participants at risk
5 mgs taken orally daily for the duration of the trial
|
Placebo
n=79 participants at risk
one daily
|
|---|---|---|---|
|
Vascular disorders
Pulmonary embolism
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Vascular disorders
Angiodisplasia
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
General disorders
Rectum biopsy
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Vascular disorders
Hypertension
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Vascular disorders
Collapse
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Spinal decomperession
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Surgical and medical procedures
Inguinal hernia repair
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Toe operation
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Aneurysm embolism
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Prostatectomy
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Surgical and medical procedures
Prostate transurethal resection
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Surgical and medical procedures
Surgery
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Surgical and medical procedures
Bowel resection
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Surgical and medical procedures
Biopsy penis
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Surgical and medical procedures
Laser prostatectomy
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Surgical and medical procedures
Appendictomy
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Surgical and medical procedures
Angioplasty
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lunger cancer metastatic
|
2.7%
2/73 • Number of events 2 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of prostate
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
General disorders
Swelling of legs
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Injury, poisoning and procedural complications
Fracture neck of femur
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Injury, poisoning and procedural complications
Fall
|
1.4%
1/73 • Number of events 2 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Injury, poisoning and procedural complications
Bladder injury
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Injury, poisoning and procedural complications
Compression fracture
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Investigations
Angiography
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Investigations
Laryngoscopy
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Investigations
Cytoscopy
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Investigations
Endoscopy
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Investigations
Angiogram
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Cardiac disorders
Atrial flutter
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Cardiac disorders
Heart block
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Cardiac disorders
Chest pain
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
2.5%
2/79 • Number of events 2 • 24 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
COPD exacerbation
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
2.5%
2/79 • Number of events 2 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Cardiac disorders
Stroke
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Eye disorders
Cataract surgery
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Eye disorders
Visual field defect
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
2.7%
2/73 • Number of events 2 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Gastrointestinal bleed
|
0.00%
0/73 • 24 months
|
2.8%
2/72 • Number of events 2 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Rectal bleeding
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Gastrointestinal disorders
Vomiting
|
2.7%
2/73 • Number of events 2 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Hepatobiliary disorders
Gallstones
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Hepatobiliary disorders
Gallbladder perforation
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Hepatobiliary disorders
Obstructive jaundice
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Hepatobiliary disorders
Hepatic disease
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Ankle swelling
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Infections and infestations
Chest infection
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Infections and infestations
Urinary infection
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Infections and infestations
Cellulitis of leg
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Infections and infestations
Cellulitis of arm
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
Other adverse events
| Measure |
Perindopril
n=73 participants at risk
10mgs orally daily for the duration of the trial
|
Amlodipine
n=72 participants at risk
5 mgs taken orally daily for the duration of the trial
|
Placebo
n=79 participants at risk
one daily
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Cardiac disorders
Heart failure
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Breathlessness
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Nervous system disorders
Diziness
|
4.1%
3/73 • Number of events 3 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Nervous system disorders
Headache
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
Nervous system disorders
Blackout
|
0.00%
0/73 • 24 months
|
1.4%
1/72 • Number of events 1 • 24 months
|
0.00%
0/79 • 24 months
|
|
General disorders
Numbness in hands, forearms, elbows
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
General disorders
Sweating
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
General disorders
Feeling sick
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
General disorders
Feeling unwell
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Gastrointestinal disorders
Upset stomach
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Skin and subcutaneous tissue disorders
Itchy skin
|
1.4%
1/73 • Number of events 1 • 24 months
|
0.00%
0/72 • 24 months
|
0.00%
0/79 • 24 months
|
|
Musculoskeletal and connective tissue disorders
Ankle swelling
|
0.00%
0/73 • 24 months
|
4.2%
3/72 • Number of events 3 • 24 months
|
0.00%
0/79 • 24 months
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
Nervous system disorders
Numbness in feet
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
|
General disorders
Other
|
0.00%
0/73 • 24 months
|
0.00%
0/72 • 24 months
|
1.3%
1/79 • Number of events 1 • 24 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place