Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement
Status:
Recruiting
Trial end date:
2025-06-30
Target enrollment:
Participant gender:
Summary
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical
aortic valve replacement for the treatment of patients with symptomatic severe aortic
stenosis. While peri-procedural complications such as stroke, vascular complications and
bleeding have substantially declined with the refinement of transcatheter valves and
increasing experience, new-onset atrial fibrillation (NOAF) or atrioventricular conduction
disturbances continue to occur in almost half of all patients.
Colchicine is a well-known substance that has been approved for the treatment of acute gout
flares and familial Mediterranean fever in many countries. Colchicine has proven safe and
effective in the prevention of atrial fibrillation after cardiac surgery. The
anti-inflammatory effects of colchicine may mitigate the occurrence of atrioventricular
conduction disturbances and thus the need for the implantation of a permanent pacemaker post
transcatheter aortic valve implantation.
The objective of the Co-STAR-Trial is to investigate the efficacy of colchicine for the
prevention of new-onset atrial fibrillation and conduction disturbances requiring the
implantation of a permanent pacemaker in patients undergoing transcatheter aortic valve
implantation.
Co-STAR is an investigator-initiated, randomized, double blind, placebo-controlled trial. A
total of 200 patients referred for treatment of symptomatic severe aortic stenosis and
selected to undergo TAVI will be randomized in a 1:1 ratio to the treatment with Colchicine
or placebo for 30 days post transcatheter aortic valve implantation.