Colchicine Effect on Perivascular Inflammation Index on Coronary CTA (COPIX)
Primary Purpose
Atherosclerosis, Inflammatory Response, Coronary Disease
Status
Recruiting
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
Colchicine
Sponsored by
About this trial
This is an interventional treatment trial for Atherosclerosis focused on measuring Perivascular adipose tissue attenuation, Fat attenuation index, Colchicine, Coronary disease, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Individuals of both sexes over 18 years of age;
- Patients undergoing coronary CT angiography from May/2021
- CT angiography showing non-calcified or mixed coronary plaques and high FAI value (> -70.1 HU) in the proximal segment of the right and/or anterior descending coronary artery with
- Willing and able (in the opinion of the investigators) to fulfill all study requirements
Exclusion Criteria:
- Past history of acute myocardial infarction
- History of percutaneous or surgical myocardial revascularization
- History of previous cardiac surgery or congenital heart disease
- Current use of colchicine
- Autoimmune disease requiring immunosuppressive therapy or current use of systemic corticosteroid therapy
- Active neoplasm with indication of surgery, chemotherapy or radiation in the last 12 months (patients with a history of neoplasm and who underwent curative surgery without need for treatment in the last 12 months will be allowed)
- Inflammatory bowel disease or chronic diarrhea
- Clinically significant non-transient hematologic abnormalities
- Renal dysfunction (GFR < 30 mL/min/1.73 m² and/or serum creatinine > 2.5 mg/dL or < 220 µmol/l)
- Severe liver disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3x ULN in the last 6 months)
- Drug addiction or alcoholism
- History of clinically significant sensitivity to colchicine
- Inability to sign the informed consent form
- Participation in another study
Sites / Locations
- Heart Institute - University of São PauloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Colchicine
Placebo
Arm Description
0.5 mg of colchicine daily for 12 months
Follow-up for 12 months
Outcomes
Primary Outcome Measures
Quantification of FAI in both groups after 12-month follow-up
Secondary Outcome Measures
Evaluation of the variation total atheroma volume
Evaluation of low attenuation plate volume variation;
Occurrence of general death
Occurrence of cardiovascular death
Occurrence of acute myocardial infarction
Occurrence of stroke
Occurrence of need for myocardial revascularization
Full Information
NCT ID
NCT05347316
First Posted
April 20, 2022
Last Updated
May 3, 2022
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05347316
Brief Title
Colchicine Effect on Perivascular Inflammation Index on Coronary CTA
Acronym
COPIX
Official Title
Colchicine Effect on Perivascular Inflammation Index on Coronary CTA(COPIX Trial)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
March 7, 2023 (Anticipated)
Study Completion Date
March 7, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Inflammation is an important pillar of atherogenesis in coronary disease. Studies have documented the prognostic power of measuring coronary perivascular adipose tissue attenuation (PVAT) and its good correlation as an early inflammatory biomarker in the atherogenesis process, in addition to being a predictor for cardiovascular events in the future. Colchicine, a medication with well-documented anti-inflammatory action and with an impact on reducing cardiovascular outcomes, may have an action in reducing FAI (fat attenuation index). This study aims to evaluate the effect of colchicine in reducing coronary perivascular inflammation.
Detailed Description
A single-center, prospective, single-blind randomized study to evaluate the efficacy of colchicine versus placebo in patients with documented FAI ≥ -70.1 HU of the proximal segment of the right coronary artery and/ou left anterior descending coronary artery and non-calcified or mixed plaques on coronary angiography performed electively after 12-month follow-up.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis, Inflammatory Response, Coronary Disease
Keywords
Perivascular adipose tissue attenuation, Fat attenuation index, Colchicine, Coronary disease, Inflammation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Colchicine
Arm Type
Experimental
Arm Description
0.5 mg of colchicine daily for 12 months
Arm Title
Placebo
Arm Type
No Intervention
Arm Description
Follow-up for 12 months
Intervention Type
Drug
Intervention Name(s)
Colchicine
Intervention Description
0.5 mg per day colchicine for 12 months
Primary Outcome Measure Information:
Title
Quantification of FAI in both groups after 12-month follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Evaluation of the variation total atheroma volume
Time Frame
12 months
Title
Evaluation of low attenuation plate volume variation;
Time Frame
12 months
Title
Occurrence of general death
Time Frame
12 months
Title
Occurrence of cardiovascular death
Time Frame
12 months
Title
Occurrence of acute myocardial infarction
Time Frame
12 months
Title
Occurrence of stroke
Time Frame
12 months
Title
Occurrence of need for myocardial revascularization
Time Frame
12 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
over 18 years
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Individuals of both sexes over 18 years of age;
Patients undergoing coronary CT angiography from May/2021
CT angiography showing non-calcified or mixed coronary plaques and high FAI value (> -70.1 HU) in the proximal segment of the right and/or anterior descending coronary artery with
Willing and able (in the opinion of the investigators) to fulfill all study requirements
Exclusion Criteria:
Past history of acute myocardial infarction
History of percutaneous or surgical myocardial revascularization
History of previous cardiac surgery or congenital heart disease
Current use of colchicine
Autoimmune disease requiring immunosuppressive therapy or current use of systemic corticosteroid therapy
Active neoplasm with indication of surgery, chemotherapy or radiation in the last 12 months (patients with a history of neoplasm and who underwent curative surgery without need for treatment in the last 12 months will be allowed)
Inflammatory bowel disease or chronic diarrhea
Clinically significant non-transient hematologic abnormalities
Renal dysfunction (GFR < 30 mL/min/1.73 m² and/or serum creatinine > 2.5 mg/dL or < 220 µmol/l)
Severe liver disease (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] > 3x ULN in the last 6 months)
Drug addiction or alcoholism
History of clinically significant sensitivity to colchicine
Inability to sign the informed consent form
Participation in another study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
CARLOS SERRANO, Doctor
Phone
+55(11) 26615447
Email
cvserranojr@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Camila Barbosa, Doctor
Phone
+55(11) 986015021
Email
dracamilatalita@gmail.com
Facility Information:
Facility Name
Heart Institute - University of São Paulo
City
São paulo
State/Province
Sao Paulo
ZIP/Postal Code
05403000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carlos Serrano, Doctor
Phone
+55 11 2661 5352
Email
cvserranojr@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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Colchicine Effect on Perivascular Inflammation Index on Coronary CTA
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