Metformin for Abdominal Aortic Aneurysm Growth Inhibition (MAAAGI)
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|ClinicalTrials.gov Identifier: NCT04224051|
Recruitment Status : Recruiting
First Posted : January 13, 2020
Last Update Posted : January 13, 2020
|Condition or disease||Intervention/treatment||Phase|
|Abdominal Aortic Aneurysm||Drug: Metformin Other: Standard care||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Metformin for AAA Growth Inhibition, a Randomized Controlled Trial|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||January 2026|
|Estimated Study Completion Date :||January 2026|
Experimental: Metformin target dose of 2g daily
Metformin tablets taken orally with target dose of 2g daily plus standard care
Metformin target dose 2 g daily
Active Comparator: Standard care
Standard care includes help with smoking cessation if applicable; encouragement of physical activity and a healthy diet; blood pressure control; statin and anti-platelet therapy treatment if the patient have clinical manifestations of atherosclerotic disease.
Other: Standard care
Abdominal aortic aneurysm surveillance
- Abdominal aortic aneurysm (AAA) diameter growth rate [ Time Frame: 5 years ]To examine if up to 2g metformin administered daily over a five-year period slows AAA growth measured as computed tomography (CT) imaging assessed AAA diameter (mm) in patients with small AAAs who do not have diabetes.
- Abdominal aortic aneurysm (AAA) volume growth rate [ Time Frame: 5 years ]To examine if up to 2g metformin administered daily over a five-year period slows AAA growth measured as computed tomography (CT) imaging assessed AAA volume (ml) in patients with small AAAs who do not have diabetes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04224051
|Contact: Jon Unosson, PhDemail@example.com|
|Contact: Anders Wanhainen, PhDfirstname.lastname@example.org|
|Uppsala University Hospital||Recruiting|
|Uppsala, Sverige, Sweden|
|Contact: Jon Unosson|
|Principal Investigator:||Jon Unosson, PhD||Uppsala University Hospital|