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

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ClinicalTrials.gov Identifier: NCT05253794
Recruitment Status : Recruiting
First Posted : February 24, 2022
Last Update Posted : August 14, 2023
Sponsor:
Information provided by (Responsible Party):
Ottawa Heart Institute Research Corporation

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
Aortic Stenosis Inflammation 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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : July 1, 2022
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : September 30, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Colchicine

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




Primary Outcome Measures :
  1. Change in aortic valve calcification activity [ Time Frame: 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 [ Time Frame: One year ]
    Change is the degree of aortic valve calcification measured using CT scan (calcium score) and expressed in arbitrary units



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05253794


Contacts
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Contact: David Messika-Zeitoun 613 796 7000 DMessika-zeitoun@ottawaheart.ca
Contact: Kevin E Boczar 613 796 7000 kboczar@ottawaheart.ca

Locations
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Canada, Ontario
University of Ottawa Heart Institute Recruiting
Ottawa, Ontario, Canada, K1Y 4W7
Contact: David Messika-Zeitoun    16136967337    DMessika-zeitoun@ottawaheart.ca   
Sponsors and Collaborators
Ottawa Heart Institute Research Corporation
Investigators
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Principal Investigator: David Messika-Zetioun@ottawaheart.ca Ottawa Heart Institute Research Corporation
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Responsible Party: Ottawa Heart Institute Research Corporation
ClinicalTrials.gov Identifier: NCT05253794    
Other Study ID Numbers: 20210526
First Posted: February 24, 2022    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Aortic Valve Stenosis
Inflammation
Constriction, Pathologic
Pathologic Processes
Pathological Conditions, Anatomical
Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases
Ventricular Outflow Obstruction
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents