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Metformin for Abdominal Aortic Aneurysm Growth Inhibition — MAAAGI  

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Metformin for AAA Growth Inhibition, a Randomized Controlled Trial

Clinical Trial Summary

A multi-centre population-based open-label randomized controlled trial with allocation concealment and blinded outcome assessment will examine if up to 2g metformin daily slows AAA growth in patients with small AAAs who do not have diabetes.

Clinical Trial Description

Subjects with no history of diabetes will be recruited from a cohort of patients with diagnosed AAA and a maximum aortic diameter of 30-49mm for men and 30-44mm for women. A total of 500 subjects with AAA will be included in the study, 250 in each study arm. Patients will be randomised to metformin or standard care in a 1:1 ratio. CT imaging and AAA US will be performed at baseline, 24 months and end of study, as well as if necessary according to clinical routine. Study drug will start at baseline and continue through completion. When all enrolled subjects have completed the 24-month follow-up (including imaging) an interim analysis will be performed to assess for efficacy and safety; if there is no trend towards a positive effect or signs of a harmful effect of metformin, the study will be stopped at this phase. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04224051
Study type Interventional
Source Uppsala University Hospital
Contact
Status Enrolling by invitation
Phase Phase 2
Start date February 12, 2020
Completion date January 2026
View Details
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