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

Primary Purpose

Aortic Stenosis, Inflammation

Status

Recruiting

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Colchicine 0.6 mg

Placebo

About this trial

This is an interventional prevention trial for Aortic Stenosis focused on measuring colchicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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);
Hemoglobin < 105(women) <110 (men) g/L; WBC < 3.0x 10(9)/L, platelet count< 110x 10(9)/L;
Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease or with alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal.
unable to give informed consent

Sites / Locations

University of Ottawa Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Colchicine

Placebo

Arm Description

Colchicine 0.6mg PO daily for 6 months

Placebo tablet daily for 6 months

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05253794

First Posted

February 1, 2022

Last Updated

August 11, 2023

Sponsor

Ottawa Heart Institute Research Corporation

1. Study Identification

Unique Protocol Identification Number

NCT05253794

Brief Title

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

Acronym

COPAS-Pilot

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Ottawa Heart Institute Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

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

Detailed Description

COPAS pilot is a pilot single center double blinded randomized study. The investigators will compare the effect of colchicine (0.6 mg daily - intervention arm) vs. placebo (control group) on the 18F NaF aortic valve uptake in patients with mild to moderate AS defined by a mean pressure gradient measured using transthoracic echocardiography (TTE) between 15-25 mm Hg after a 6-month period of treatment. The investigators plan to enroll 12 patients (6 males/6 females) in each arm (total sample size: 24 patients). Primary endpoint is the change in 18FNaF aortic valve uptake between baseline and 6 months in each arm. Parameters of interest are the maximal and total standard uptake values (SUVs) and tissue-to background ratios (TBRs) at the level of the aortic valve.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Aortic Stenosis, Inflammation

Keywords

colchicine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Colchicine

Arm Type

Experimental

Arm Description

Colchicine 0.6mg PO daily for 6 months

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo tablet daily for 6 months

Intervention Type

Drug

Intervention Name(s)

Colchicine 0.6 mg

Intervention Description

oral tablet daily for 6 months

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

oral tablet daily for 6 months

Primary Outcome Measure Information:

Title

Change in aortic valve calcification activity

Description

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

Time Frame

6 months

Other Pre-specified Outcome Measures:

Title

Change in aortic valve calcification

Description

Change is the degree of aortic valve calcification measured using CT scan (calcium score) and expressed in arbitrary units

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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); Hemoglobin < 105(women) <110 (men) g/L; WBC < 3.0x 10(9)/L, platelet count< 110x 10(9)/L; Patient with a history of cirrhosis, chronic active hepatitis or severe hepatic disease or with alanine aminotransferase (ALT) levels greater than 3 times the upper limit of normal. unable to give informed consent

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Messika-Zeitoun

Phone

613 796 7000

DMessika-zeitoun@ottawaheart.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Kevin E Boczar

Phone

613 796 7000

kboczar@ottawaheart.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Messika-Zetioun@ottawaheart.ca

Organizational Affiliation

Ottawa Heart Institute Research Corporation

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Ottawa Heart Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1Y 4W7

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Messika-Zeitoun

Phone

16136967337

DMessika-zeitoun@ottawaheart.ca

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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