Ignite Creation Date:
2024-05-06 @ 2:07 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04224051
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-09-06
First Post:
2020-01-01
Brief Title:
Metformin for Abdominal Aortic Aneurysm Growth Inhibition
Sponsor:
Uppsala University Hospital
Organization:
Uppsala University Hospital
Study Overview
Official Title:
Metformin for AAA Growth Inhibition a Randomized Controlled Trial
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MAAAGI
Brief 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
Detailed 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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None