NCT07035405尚未招募3 期
Colchicine for Secondary Prevention After Ischemic Stroke (CHANCE-3 EX): a Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
Beijing Tiantan Hospital0 个研究点目标入组 7,500 人开始时间: 2025年7月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 7,500
- 主要终点
- First Event of ischemic stroke, myocardial infarction and vascular death
研究概览
简要总结
The role of colchicine in the secondary prevention of ischemic stroke has not been determinded. This multicenter, randomized, double-blind, placebo-controlled, event-driven clinical trial of CHANCE-3 EX was aimed to assess the efficacy and safety of low-dose colchicine versus placebo on reducing the risk of recurrent ischemic stroke, myocardial infarction and vascular death in patients with minor-to-moderate ischemic stroke.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •An age of 18-80 years old
- •Minor-to-moderate ischemic stroke (NIHSS<15 at randomization; confirmed by CT or MRI)
- •Within 7-30 days after the most recent qualifying stroke onset
- •Informed consent signed
排除标准
- •Iatrogenic causes (angioplasty or surgery) of stroke
- •mRS>3 at randomization
- •Known allergy, sensitivity or intolerance to colchicine
- •Inflammatory bowel disease (Crohn's or ulcerative colitis) or chronic diarrhea
- •Symptomatic peripheral neuropathy or pre-existing progressive neuromuscular disease or with creatine kinase (CK) level > 3 times the upper limit of normal as measured within the past 30 days and determined to be non-transient through repeat testing
- •A history of cirrhosis, chronic active hepatitis or severe hepatic disease
- •Impaired hepatic (ALT or AST > three times the upper limit of normal range) or kidney (creatinine exceeding 1.5 times of the upper limit of normal range or eGFR less than 50 ml/min) function at randomization
- •Anemia (haemoglobin <10g/dL), thrombocytopenia (platelet count <100×109/L) or leucopenia (white blood cell count <3×109/L) at randomization
- •Comorbid gout or other indications for colchicine use
- •Active infection at randomization (including respiratory tract infection, urinary tract infection, or gastroenteritis)
- •Requiring chronic immunosuppressant, glucocorticoid, or nonsteroidal anti-inflammatory drugs therapy (except aspirin) during the study
- •Usage of contraindicated medications for colchicine at randomization: moderate or strong CYP3A4 inhibitors (clarithromycin, erythromycin, telithromycin, other macrolide antibiotics, ketoconazole, itraconazole, voriconazole, ritonavir, atazanavir, indinavir, other HIV protease inhibitors, verapamil, diltiazem, quinidine, digoxin, disulfiram, etc) or P-gp inhibitors (cyclosporine)
- •Participating in another clinical trial with an investigational drug or device concurrently or during the last 30 days
- •Women of childbearing age who were not practicing reliable contraception and did not have a documented negative pregnancy test
- •Severe non-cardiovascular comorbidity, active malignant tumors or terminal-stage illnesses, with a life expectancy of less than 2 years
- •Clinically significant drug or alcohol abuse in the past year
- •Any other conditions deemed unsuitable for participation in this study or inability to complete study procedures, including but not limited to mental disorders, cognitive or emotional impairments, or physical conditions that may compromise compliance with study protocols and follow-up visits
研究组 & 干预措施
Colchicine Group
Experimental
Patients in this arm will receive low-dose colchicine in addition to standard medical care
干预措施: Colchicine 0.5 mg (Drug)
Placebo Colchicine Group
Placebo Comparator
Patients in this arm will receive placebo colchicine in addition to standard medical care
干预措施: Placebo colchicine (Drug)
结局指标
主要结局
First Event of ischemic stroke, myocardial infarction and vascular death
时间窗: From randomization to occurrence of the first event, with a median follow-up time of 24 months
The descriptive statistics are the number of participants having at least one of the composites of the primary endpoint.
次要结局
- Ischemic stroke(From randomization to event, with a median follow-up time of 24 months.)
- Myocardial Infarction(From randomization to event, with a median follow-up time of 24 months.)
- Vascular death(From randomization to death, with a median follow-up time of 24 months.)
- mRS 0-1 at 1 year or ≥1-point improvement in mRS score from baseline to 1 year(At 1 year)
- mRS shift(At 1 year)
研究者
Yongjun Wang
Principal Investigator
Beijing Tiantan Hospital
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