Your session is about to expire
← Back to Search
Anti-inflammatory
Colchicine for Aortic Stenosis (COPAS-Pilot Trial)
Phase 2 & 3
Recruiting
Led By David Messika-Zetioun@ottawaheart.ca
Research Sponsored by Ottawa Heart Institute Research Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Mild to moderate aortic stenosis defined by a mean pressure gradient using transthoracic echocardiography (TTE) between 15-25mmHg
Age greater than 18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
COPAS-Pilot Trial Summary
This trial is testing whether colchicine, an anti-inflammatory drug, can reduce valvular calcification (hardening of the valves) over 6 months when compared to placebo.
Who is the study for?
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.Check my eligibility
What is being tested?
The COPAS pilot is testing whether Colchicine can slow down the hardening of the aortic valve by comparing it against a placebo. Participants will be randomly assigned to one of these two groups in a double-blind manner and monitored for 6 months using NaF PET imaging.See study design
What are the potential side effects?
Colchicine may cause side effects like digestive upset (nausea, diarrhea), blood disorders, muscle pain or weakness. Since this is a blinded trial, participants won't know if they're getting Colchicine or the placebo until after the study.
COPAS-Pilot Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart valve narrowing is mild to moderate.
Select...
I am older than 18 years.
COPAS-Pilot Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in aortic valve calcification activity
Other outcome measures
Change in aortic valve calcification
Side effects data
From 2015 Phase 3 trial • 100 Patients • NCT019854256%
Acute Respiratory Distress Syndrome
4%
fall
100%
80%
60%
40%
20%
0%
Study treatment Arm
Active Colchicine
Placebo Colchicine
COPAS-Pilot Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ColchicineExperimental Treatment1 Intervention
Colchicine 0.6mg PO daily for 6 months
Group II: PlaceboPlacebo Group1 Intervention
Placebo tablet daily for 6 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Colchicine 0.6 mg
2021
Completed Phase 3
~780
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
188 Previous Clinical Trials
92,412 Total Patients Enrolled
4 Trials studying Inflammation
239 Patients Enrolled for Inflammation
David Messika-Zetioun@ottawaheart.caPrincipal InvestigatorOttawa Heart Institute Research Corporation
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not taking medications like cyclosporine, verapamil, or ketoconazole.My heart valve narrowing is mild to moderate.I have moderate or severe heart valve problems.I have chronic diarrhea.I am not willing to use two forms of birth control during the study.I have an active inflammatory condition or am on systemic anti-inflammatory therapy.I often get infections due to a weak immune system.My kidney function is reduced with a GFR less than 50.I am older than 18 years.Your hemoglobin (for women) or white blood cell count is too low, or your platelet count is too low.I haven't had any cancer in the past 3 years, except for certain skin cancers or early-stage cervical cancer.I am unable to understand and agree to the study's procedures and risks.I have severe liver issues or my ALT levels are three times above the normal limit.I have moderate to severe leakage in my heart valve.My heart's pumping ability is reduced.My heart cannot pump blood effectively anymore.I have a two-leaf aortic valve.I do not have any active infections requiring antibiotics.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Colchicine
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being signed up for this experiment?
"The latest information from clinicaltrials.gov suggests that this study is still searching for participants. The trial's first posting was on July 1st, 2022 and the most recent update was on August 16th, 2022."
Answered by AI
How many people are currently enrolled in this research?
"That is correct, the online information indicates that the study is ongoing and looking for 24 additional patients at a single site."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger