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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
Must not have
Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole)
Associated other valvular pathology of moderate or greater severity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Summary
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.
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.
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.
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My heart valve narrowing is mild to moderate.
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I am older than 18 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not taking medications like cyclosporine, verapamil, or ketoconazole.
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I have moderate or severe heart valve problems.
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I have chronic diarrhea.
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I am not willing to use two forms of birth control during the study.
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I have an active inflammatory condition or am on systemic anti-inflammatory therapy.
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I often get infections due to a weak immune system.
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My kidney function is reduced with a GFR less than 50.
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I am unable to understand and agree to the study's procedures and risks.
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I have severe liver issues or my ALT levels are three times above the normal limit.
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I have moderate to severe leakage in my heart valve.
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My heart's pumping ability is reduced.
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My heart cannot pump blood effectively anymore.
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I have a two-leaf aortic valve.
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I do not have any active infections requiring antibiotics.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in aortic valve calcification activity
Other study objectives
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
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
~980
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Colchicine, a common anti-inflammatory treatment, works by inhibiting microtubule polymerization, which reduces neutrophil activity and migration to inflammation sites. This mechanism helps decrease the overall inflammatory response, making it an effective option for reducing inflammation and its symptoms, thereby potentially improving patient outcomes and quality of life.
Find a Location
Who is running the clinical trial?
Ottawa Heart Institute Research CorporationLead Sponsor
194 Previous Clinical Trials
92,988 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.
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