An evaluation of the effect of an angiotensin-converting enzyme (ACE) inhibitor on the growth rate of small abdominal aortic aneurysms

Phase 4

Completed

• Conditions: Asymptomatic abdominal aortic aneurysm; Circulatory System; Aortic aneurysm and dissection

• Registration Number: ISRCTN51383267
• Lead Sponsor: Imperial College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-16
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 225

Inclusion Criteria

1. Willing and able to give written informed consent
2. Men or women, aged at least 60 years
3. AAA 3 to 5.4 cm in diameter according to ultrasound measurement
4. Systolic blood pressure (SBP) less than 150 mmHg (unless they require and are already receiving an ACE-inhibitor or amlodipine 10 mg daily). For patients whose SBP is greater than 150 mmHg, a 6-week course of the diuretic indapamide SR (1.5 mg daily) will be given, with re-evaluation of BP in the 6th week. If the SBP falls to less than 150 mmHg on this medication subjects would then be eligible for randomisation into the study. If this diuretic treatment is not appropriate then 5 mg of amlodipine could be prescribed by the patients GP if not already taking this drug. This would be followed by a six week re-evaluation as above.

Exclusion Criteria

1. 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/or a 5 mg dose of amlodipine for control (i.e., SBP less than 150 mmHg) of their BP
2. Those with known renal artery stenosis (greater than 50%), or with a serum creatinine of greater than 180 µmol/L
3. Those unable to give informed consent
4. Those too frail to travel for 3-monthly surveillance
5. Any clinically significant medical condition which, in the opinion of the investigator, may interfere with the study results and or reduce life expectancy to less than 2 years
6. Participation in another trial of an investigational product or device within the previous 30 days
7. Known allergy or sensitivity to perindopril or amlodipine
8. Unable or unwilling to comply with the requirements of the study, in the opinion of the investigator

Study & Design

• Study Type: Interventional
• Study Design: Not specified