Colchicine Effect on Perivascular Inflammation Index on Coronary CTA(COPIX Trial)
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Quantification of FAI in both groups after 12-month follow-up
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Colchicine
0.5 mg of colchicine daily for 12 months
干预措施: Colchicine (Drug)
结局指标
主要结局
Quantification of FAI in both groups after 12-month follow-up
时间窗: 12 months
次要结局
- Occurrence of acute myocardial infarction(12 months)
- Occurrence of general death(12 months)
- Evaluation of the variation total atheroma volume(12 months)
- Occurrence of cardiovascular death(12 months)
- Occurrence of stroke(12 months)
- Evaluation of low attenuation plate volume variation;(12 months)
- Occurrence of need for myocardial revascularization(12 months)
研究者
Carlos Vicente Serrano Jr
MD PhD
University of Sao Paulo General Hospital