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

Sponsor
Ottawa Heart Institute Research Corporation (Other)
Overall Status
Recruiting
CT.gov ID
NCT05253794
Collaborator
(none)
24
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Colchicine 0.6 mg
  • Drug: Placebo
 Phase 2/Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
24 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Colchicine on the Progression of Aortic Valve Stenosis - A Pilot Study
Actual Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Colchicine

Colchicine 0.6mg PO daily for 6 months

Drug: Colchicine 0.6 mg
oral tablet daily for 6 months
Placebo Comparator: Placebo

Placebo tablet daily for 6 months

Drug: Placebo
oral tablet daily for 6 months

Outcome Measures

Primary Outcome Measures

  1. Change in aortic valve calcification activity [6 months]

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

Other Outcome Measures

  1. Change in aortic valve calcification [One year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. mild to moderate aortic stenosis defined by a mean pressure gradient using transthoracic echocardiography (TTE) between 15-25mmHg.

  2. age greater than18 years;

  3. given informed consent.

Exclusion Criteria:

  1. bicuspid aortic valve

  2. associated moderate to severe aortic regurgitation

  3. associated other valvular pathology of moderate or greater severity

  4. LV dysfunction (EF<50%);

  5. decompensated heart failure;

  6. active infection (e.g. pneumonia, active skin infections, and on antibiotics);

  7. chronic diarrhea;

  8. immune compromise (e.g. recurrent infection);

  9. 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).

  10. active inflammatory conditions (e.g. rheumatoid arthritis, chronic inflammatory bowel disease, SLE, systemic anti-inflammatory therapy (e.g. prednisone, methotrexate));

  11. pregnancy (all women of child bearing potential will have a negative BHCG test;

  12. breastfeeding;

  13. 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.

  14. glomerular filtration rate (GFR) <50 ml/min/1.72m2;

  15. Use of p-glycoprotein inhibitor (e.g. cyclosporine, verapamil, or quinidine) or a strong CYP3A4 inhibitor (e.g. ritonavir, clarithromycin, or ketoconazole);

  16. Hemoglobin < 105(women) <110 (men) g/L; WBC < 3.0x 10(9)/L, platelet count< 110x 10(9)/L;

  17. 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.

  18. unable to give informed consent

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Ottawa Heart Institute Ottawa Ontario Canada K1Y 4W7

Sponsors and Collaborators

  • Ottawa Heart Institute Research Corporation

Investigators

  • Principal Investigator: David Messika-Zetioun@ottawaheart.ca, Ottawa Heart Institute Research Corporation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier:
NCT05253794
Other Study ID Numbers:
  • 20210526
First Posted:
Feb 24, 2022
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Ottawa Heart Institute Research Corporation
colchicine
Additional relevant MeSH terms:
Aortic Valve Stenosis
Inflammation
Constriction, Pathologic
Colchicine

Study Results

No Results Posted as of Aug 17, 2022