NCT06025071尚未招募4 期
Efficacy and Safety of Residual Inflammatory Risk-Guided Low-dose Colchicine Therapy in Elderly Patients With Multivessel Coronary Artery Disease: A Multicenter Randomized Controlled Trial
Chinese Academy of Medical Sciences, Fuwai Hospital1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2023年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
研究概览
简要总结
The goal of this clinical trial is to compare low-dose colchicine (0.5 mg Once Daily) with no specific intervention in selected elderly patients (60-80 years old) with residual inflammatory risk (hs-CRP≥ 2mg/L) and multivessel coronary artery disease. The main questions it aims to answer are:
- Whether the intervention is effective in reducing ischemic events
- Whether the intervention is effective in reducing inflammatory biomarkers' level
- Whether the intervention is safe for elderly patients
Participants will be randomized to receive low-dose colchicine (0.5 mg Once Daily) or no specific intervention for one year. Patients enrolled should complete one-year follow-up in the form of clinic visit or telephone call.
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)
盲法说明
This is an open-lable study. But while the study is in progress, the grouping information is masked from outcome assessors.
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60-80 years old
- •Baseline plasma hs-CRP≥2 mg/L
- •Hospitalized patients with coronary artery disease with multi-vessel lesions (multi-vessel lesions are defined as at least 2 major epicardial coronary arteries with ≥50% stenosis in their main branch diameter confirmed by coronary CT or coronary angiography, with or without left main artery disease)
- •Patients with myocardial ischemia-related symptoms or objective evidence are successfully treated with PCI, and the condition is relatively stable
- •Received standard drug therapies based on their condition at baseline (including antiplatelet, lipid-lowering, blood pressure control, blood glucose control, and other treatments recommended by guidelines)
- •Subjects or legal representatives have signed informed consent.
排除标准
- •Patients who have acute myocardial infarction within 30 days
- •Patients who have taken colchicine and have a clear history of allergy or intolerance
- •Patients with renal insufficiency, eGFR <30 ml/min/1.73 m^2 (calculated by MDRD formula) or blood creatinine levels exceeding 2 times the upper normal limit
- •Patients with cirrhosis, chronic active hepatitis, liver function impairment (alanine aminotransferase exceeding 3 times the upper normal limit or total bilirubin exceeding 2 times the upper normal limit) or cholestasis
- •Patients with a known history of hypomyelodysplasia
- •Patients with heart failure (NYHA Class III-IV) or severe valvular disease
- •Patients with concomitant neoplastic or cancer disease
- •Patients with chronic obstructive pulmonary disease or other chronic pulmonary disease
- •Patients with poorly controlled disease, such as current cardiogenic shock, hemodynamic instability, heart failure (NYHA Class III-IV), left ventricular ejection fraction less than 35%, recent stroke (within the past 3 months), or any other condition in which the investigator believes that participation in this study puts the patient at risk
- •Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis) or chronic diarrhea
- •Patients with hemoglobin less than 115 g/L, white blood cell count less than 4.0*10^9/L, or platelet count less than 110*10^9/L
- •Patients are currently using or plan to begin chronic systemic steroid therapy (oral or intravenous) during the study period (topical or inhaled steroids are allowed)
- •Patients with acute inflammation or viral infection
- •Female patients who are currently pregnant, planning to become pregnant, or breastfeeding
研究组 & 干预措施
Colchicine group
Experimental
Drug: Colchicine; Dosage form: Tablets; Dosage: 0.5mg; Frequency: Once daily; Duration: From randomization to one-year follow-up is completed.
干预措施: colchicine (Drug)
结局指标
主要结局
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
时间窗: From randomization to occurence of first event, assessed up to one year
Composite events including cardiovascular death, spontaneous (nonprocedural) myocardial infarction, ischemia-driven coronary revascularization, and ischemic stroke
次要结局
- Cardiovascular death(From randomization to occurence of first event, assessed up to one year)
- Spontaneous (nonprocedural) myocardial infarction(From randomization to occurence of first event, assessed up to one year)
- Ischemic stroke(From randomization to occurence of first event, assessed up to one year)
- Change of white blood cell count(From randomization to treatment at one month and one year)
- Change of monocyte count(From randomization to the end of treatment at one year)
- Ischemia-driven coronary revascularization(From randomization to occurence of first event, assessed up to one year)
- Change of hs-CRP(From randomization to treatment at one month and one year)
- Change of neutrophil count(From randomization to treatment at one month and one year)
研究者
Xueyan Zhao
Chief physician, M.D., FACC, FESC, Doctoral supervisor
Chinese Academy of Medical Sciences, Fuwai Hospital
研究点 (1)
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