The Metformin Aneurysm Trial

Phase 3

Recruiting

• Conditions: Abdominal Aortic Aneurysm (AAA); Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system

• Registration Number: ACTRN12618001707257
• Lead Sponsor: James Cook University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-16
• Last Update Posted: 23 May 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 1954

Inclusion Criteria

1) An infrarenal AAA with a diameter of 35mm or greater on imaging with the treating doctor indicating that repair is not planned within the next 12 months.

2) At least 18 years old and provides valid informed consent

Exclusion Criteria

1) Symptomatic, ruptured or infected AAA;

2) Previous abdominal aortic surgery;

3) Contraindications to metformin, including renal impairment (eGFR <45ml/min/1.73m2), severe heart failure (defined as New York Heart Association Class IV) requiring in-patient treatment within the last 12 months or leading to shortness of breath at rest, or previous allergic reaction to metformin;

4) Current indication for metformin (i.e. diabetes defined by HbA1c 6.5% or greater);

5) Involvement in another drug trial;

6) Terminal illness

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
AAA-associated events: including AAA repair and AAA mortality (due to aneurysm rupture). This information will be collected via telephone calls with the patient and medical records.[Follow-up will occur until 616 primary outcome events have been accrued (estimated to require a median of ~3.5 years follow-up)<br>]