Colchicine for Aortic Stenosis
(COPAS-Pilot Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests if colchicine, an anti-inflammatory drug, can reduce calcium buildup in the heart valves of patients with mild to moderate aortic stenosis. The study will test colchicine over several months to see if it helps reduce valve hardening. Colchicine has shown modest benefits in early nonsevere COVID-19 but is associated with common adverse effects.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using certain medications like p-glycoprotein inhibitors or strong CYP3A4 inhibitors.
How does the drug colchicine differ from other treatments for aortic stenosis?
Who Is on the Research Team?
David Messika-Zetioun@ottawaheart.ca
Principal Investigator
Ottawa Heart Institute Research Corporation
Are You a Good Fit for This Trial?
Adults over 18 with mild to moderate aortic stenosis (15-25mmHg pressure gradient) can join this study. They must be able to consent and agree to use two forms of contraception if capable of childbearing. Excluded are those with severe heart issues, liver disease, immune compromise, certain medication use, recent cancer (except some skin cancers), pregnancy, breastfeeding or poor kidney function.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive colchicine or placebo daily for 6 months to assess the effect on aortic valve calcification
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Colchicine
Colchicine is already approved in United States for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ottawa Heart Institute Research Corporation
Lead Sponsor