Effect of Colchicine on the Progression of Aortic Valve Stenosis - A Pilot Study

NCT05253794 | Completed Phase 2 DMC

• 1 other identifier: 20210526
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

COPAS pilot is a pilot single center double blinded randomized study to determine the effect of targeted anti-inflammation therapy using colchicine, on valvular calcification activity using imaging, i.e. aortic valvular NaF uptake. The current proposal uses a randomized design to evaluate the effect of colchicine vs. placebo on valvular calcification activity over 6 months measured using NaF PET

Conditions

Aortic Stenosis; Inflammation

Keywords

colchicine

Outcome Measures

Primary Outcomes (1)

• Change in aortic valve calcification activity

  Change in valvular calcification activity as measured by NaF uptake by Target to Background Ratio (TBR) on PET/CT imaging

  6 months

Other Outcomes (1)

• Change in aortic valve calcification

  One year

Study Arms (2)

Colchicine

EXPERIMENTAL

Colchicine 0.6mg PO daily for 6 months

Drug: Colchicine 0.6 mg

Placebo

PLACEBO COMPARATOR

Placebo tablet daily for 6 months

Drug: Placebo

Interventions

Colchicine 0.6 mg DRUG

oral tablet daily for 6 months

Colchicine

Placebo DRUG

oral tablet daily for 6 months

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to moderate aortic stenosis defined by a mean pressure gradient using transthoracic echocardiography (TTE) between 15-25mmHg.
• age greater than18 years;
• given informed consent.

You may not qualify if:

• bicuspid aortic valve
• associated moderate to severe aortic regurgitation
• associated other valvular pathology of moderate or greater severity
• LV dysfunction (EF\<50%);
• decompensated heart failure;
• active infection (e.g. pneumonia, active skin infections, and on antibiotics);
• chronic diarrhea;
• immune compromise (e.g. recurrent infection);
• history of cancer within the last 3 years (other than a successfully treated cutaneous squamous cell or basal cell carcinoma or localized carcinoma in situ of the cervix).
• active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));
• pregnancy (all women of child bearing potential will have a negative BHCG test;
• breastfeeding;
• Women of childbearing potential who refuse to use two forms of contraception (this includes at least one form of highly effective and one effective method of contraception) throughout the study OR men capable of fathering a child who refuse to use contraception.
• glomerular filtration rate (GFR) \<50 ml/min/1.72m2;
• Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);

Sponsors & Collaborators

• Ottawa Heart Institute Research Corporation: lead

Study Sites (1)

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Inflammation

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• David Messika-Zetioun@ottawaheart.ca

  Ottawa Heart Institute Research Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 24, 2022
• Study Start: July 1, 2022
• Primary Completion: July 31, 2024
• Study Completion: January 20, 2025
• Last Updated: May 6, 2026

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)