Cyclosporine A in Patients With Small Diameter Abdominal Aortic Aneurysms
Status:
Unknown status
Trial end date:
2018-09-01
Target enrollment:
Participant gender:
Summary
Aneurysms of the aorta are dilatations of the main artery in the body that distributes blood
to organs. Aneurysms expose patients to aortic rupture. The risk of aortic rupture is high
for large aneurysms, and low for small aneurysms. Currently, if the diameter of a small
aneurysm grows up to a level at risk for rupture, surgery is indicated to prevent rupture. A
drug that would stop growth of small aneurysms would obviate aortic surgery, the current
treatment to prevent aortic rupture in patients. The ACA4 study aims at testing the
possibility to stop growth of small aortic aneurysms in the abdomen with a drug, cyclosporine
A. Patients with small aneurysms will receive cyclosporine A orally, or a placebo (fake
liquid), every day during a short period of time. Efficacy of the drug will be evaluated by
measuring the diameter of the aneurysm during 2 years after treatment cessation. Drug safety
analysis will evaluate the impact of the drug on renal function, blood pressure, and other
parameters. In case of adverse event during the drug administration phase, dose of the drug
or of the placebo will be decreased or administration stopped.