What side effects are associated with this type of intervention?

Common anti-inflammatory treatments like colchicine, NSAIDs, and glucocorticoids have distinct side effect profiles. Colchicine can cause gastrointestinal issues such as diarrhea, nausea, and abdominal pain. NSAIDs are associated with gastrointestinal bleeding, renal impairment, and cardiovascular risks. Glucocorticoids can lead to weight gain, osteoporosis, hypertension, and increased susceptibility to infections. These side effects should be carefully considered when selecting an anti-inflammatory therapy.

What prior FDA approvals exist?

Several anti-inflammatory drugs have received FDA approval for the treatment of various inflammatory conditions. Colchicine, an anti-inflammatory agent, is commonly used for gout flares. Other notable FDA-approved anti-inflammatory treatments include biologic agents such as TNF inhibitors (e.g., infliximab, adalimumab) and IL-23 inhibitors (e.g., risankizumab) for conditions like Crohn's disease and ulcerative colitis. These drugs target specific inflammatory pathways to reduce inflammation and manage symptoms effectively.

What other types of research exist?

Promising novel alternatives to colchicine for inflammation treatment include interleukin inhibitors such as canakinumab (IL-1 beta blocker) and tocilizumab (IL-6 inhibitor), TNF inhibitors like etanercept and infliximab, and JAK inhibitors such as tofacitinib and upadacitinib. These agents have shown efficacy in clinical trials for various inflammatory conditions and may offer effective treatment options in 2024.

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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

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 below

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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:

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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.

Select...

My kidney function is reduced with a GFR less than 50.

Select...

I am unable to understand and agree to the study's procedures and risks.

Select...

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.

Select...

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.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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 • NCT01985425

Acute Respiratory Distress Syndrome

fall

100%

80%

60%

40%

20%

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

0 / 16Eligibility criteria met

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.