Last updated 4 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/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

: 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

StudyCOPIX

SponsorUniversity of Sao Paulo General Hospital

Study typeInterventional

Conditions

Coronary heart disease

Requirements

From 18 YearsAll Gender

Unique study IDclinicaltrials.gov

NCT05347316