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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05347316
Other study ID # SDC 5327/21/102
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date March 7, 2022
Est. completion date March 7, 2025

Study information

Verified date May 2022
Source University of Sao Paulo General Hospital
Contact CARLOS SERRANO, Doctor
Phone +55(11) 26615447
Email cvserranojr@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 40
Est. completion date March 7, 2025
Est. primary completion date March 7, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Drug:
Colchicine
0.5 mg per day colchicine for 12 months

Locations

Country Name City State
Brazil Heart Institute - University of São Paulo São paulo Sao Paulo

Sponsors (1)

Lead Sponsor Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Quantification of FAI in both groups after 12-month follow-up 12 months
Secondary Evaluation of the variation total atheroma volume 12 months
Secondary Evaluation of low attenuation plate volume variation; 12 months
Secondary Occurrence of general death 12 months
Secondary Occurrence of cardiovascular death 12 months
Secondary Occurrence of acute myocardial infarction 12 months
Secondary Occurrence of stroke 12 months
Secondary Occurrence of need for myocardial revascularization 12 months
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