Last updated 2 years ago
Colchicine Effect on Perivascular Inflammation Index on Coronary CTA
40 patients around the world
Available in Brazil
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.
University of Sao Paulo General Hospital
40Patients around the world
This study is for people with
Coronary heart disease
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Individuals of both sexes over 18 years of age;Patients undergoing coronary CT angiography from May/2021CT 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
- Past history of acute myocardial infarctionHistory of percutaneous or surgical myocardial revascularizationHistory of previous cardiac surgery or congenital heart diseaseCurrent use of colchicineAutoimmune disease requiring immunosuppressive therapy or current use of systemic corticosteroid therapyActive 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 diarrheaClinically significant non-transient hematologic abnormalitiesRenal 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 alcoholismHistory of clinically significant sensitivity to colchicineInability to sign the informed consent formParticipation in another study
StudyCOPIX
SponsorUniversity of Sao Paulo General Hospital
Study typeInterventional
Conditions
Coronary heart disease
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05347316
