RecruitingPhase 3Phase 4ACTRN12618001707257

The Metformin Aneurysm Trial

Sponsor

James Cook University

Enrollment

1,954 participants

Start Date

Feb 8, 2021

Study Type

Interventional

Conditions

Abdominal Aortic Aneurysm (AAA)

Summary

MAT is a multicentre, randomised, placebo-controlled trial to assess if 1500 mg of metformin per day will reduce Abdominal Aortic Aneurysm (AAA)-related events in patients with small AAAs who do not have diabetes. In order to allow reliable assessment of any beneficial effects of metformin on important AAA outcomes, including repair or AAA mortality, follow-up will occur until 616 primary outcome events have been accrued (estimated to require a median of ~3.5 years follow-up). In order to study 1,954 people with small AAA for ~3.5 years at low cost, MAT is streamlined to minimise extra work on collaborating doctors and hospitals. Only essential data will be collected and entered directly into a database. If it can be reliably demonstrated that metformin reduces the risk of AAA events in people with small AAA who do not have diabetes, then this would be relevant to some tens of millions of people worldwide who are currently receiving no treatment of their AAA. This important international study is being led by the Central Coordinating Centre at the Queensland Research Centre for Peripheral Vascular Disease.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria2

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.
At least 18 years old and provides valid informed consent

Exclusion Criteria6

Symptomatic, ruptured or infected AAA;
Previous abdominal aortic surgery;
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;
Current indication for metformin (i.e. diabetes defined by HbA1c 6.5% or greater);
Involvement in another drug trial;
Terminal illness

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Interventions

Study Design: Parallel group, blinded, placebo-controlled randomized clinical trial. INTERVENTION - metformin extended release: three 500mg capsules per day (1500mg/day). Pre-randomisation Run-In

Study Design: Parallel group, blinded, placebo-controlled randomized clinical trial. INTERVENTION - metformin extended release: three 500mg capsules per day (1500mg/day). Pre-randomisation Run-In Titration (-6-0 weeks): Participants in both arms undergoe a single blinded 6-week pre-randomisation run-in as a part of the screening process. Week 1 - 2: one 500mg capsule per day (~500mg/day). Week 3 - 4: two 500mg capsules per day (~1000mg/day). Week 5 - 6: three 500mg capsules per day (~1500mg/day). Capsules are consumed together once a day. After randomisation follow-up (approximately 3.5 years post titration period): participants will continue to take 1500mg/day until the end of the trial which is expected to be around 3.5-years. Compliance with study treatment will be reviewed by asking participants how regularly they take the study treatment (every day [about 100%], nearly every day [about 80-99%], some days [about 40-79%], a few days [about 10-39%], almost never [about 1-9%] or never [0%]). Participants will also asked at each follow-up how many tablets are remaining.