Colchicine for the Prevention of Recurrence in Cerebral Amyloid Angiopathy RElated IntraCerebral Hemorrhage (CARE-ICH)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Incidence of treatment emergent adverse events (TEAE)
研究概览
简要总结
The goal of this clinical trial is to assess the safety and tolerability of colchicine for preventing intracerebral haemorrhage (ICH) recurrence in patients with cerebral amyloid angiopathy (CAA)-ICH at high risk of recurrence.
The main questions it aims to answer are:
- Is colchicine safe for CAA-ICH patients?
- Is colchicine well tolerated for CAA-ICH patients? Researchers will compare colchicine to a placebo (a look-alike substance that contains no drug) to see if colchicine is safe and tolerable for CAA-ICH patients and works to prevent ICH recurrence.
Participants will:
- Take colchicine or a placebo every day for 12 months
- Receive telephone follow-ups at 3 and 9 months, and visit the clinic at 6 and 12 months for checkups and tests
- Control blood pressure and improve lifestyle
详细描述
The CARE-ICH study is a multicenter, randomized, double-blind, placebo-controlled, phase II trial. The primary objective of the CARE-ICH study is to assess the safety and tolerability of colchicine for preventing ICH recurrence in patients with CAA-ICH at high risk of recurrence, as well as provide a preliminary estimate of the feasibility and efficacy for planning a phase III trial.
Patients with CAA-ICH and a high risk of recurrence-defined as 1 prior symptomatic ICH and presence of cortical superficial siderosis, or ≥2 prior symptomatic ICHs-within 3 months of their most recent ICH will be enrolled and randomized in a 1:1 ratio to receive either oral colchicine 0.5 mg once per day or matching placebo for 1 year, in addition to standard care, including blood pressure control and lifestyle modifications. Follow-up visits will take place at 3, 6, 9, and 12 months. Each visit will include assessments of adverse events, medication adherence, and clinical outcomes. The primary outcomes are the incidence of treatment-emergent adverse events and treatment tolerability.
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)
盲法说明
Double-blind
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥55 years;
- •Diagnosed with "probable CAA with supporting pathology" or "probable CAA" according to the modified Boston criteria (version 1.5);
- •High risk of recurrent ICH, defined as: 1 prior symptomatic ICH and presence of cortical superficial siderosis (cSS), or ≥2 prior symptomatic ICHs;
- •Time interval since symptom onset of the most recent ICH: ≤3 months (earlier enrollment is preferred if criteria are met);
- •Modified Rankin Scale (mRS) score ≤4 at randomization;
- •Written informed consent from the participant or their legally authorized representative before study enrollment.
排除标准
- •Secondary causes of ICH;
- •Pre-existing moderate-to-severe renal, liver or blood disorders (anaemia [hemoglobin <10g/dL], thrombocytopaenia [platelet count <100×109/L], leucopenia [white blood cell <3×109/L], cirrhosis or severe hepatic dysfunction, renal insufficiency [estimated glomerular filtration rate (eGFR) <15mL/min]);
- •Prior diagnosis of gout, peripheral neuropathy, myopathy, inflammatory bowel disease or chronic diarrhea;
- •Concurrent treatment with regular immune-suppressant (corticosteroids, cyclophosphamide, azathioprine, mycophenolate mofetil, rituximab), moderate-to-strong CYP3A4 inhibitors (atazanavir, clarithromycin, darunavir/ritonavir, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, tipranavir/ritonavir) or P-glycoprotein inhibitors (cyclosporine, ranolazine);
- •Known allergy, sensitivity or intolerance to colchicine;
- •Contraindications or inability to complete brain MRI or susceptibility weighted imaging (SWI) scans;
- •Pregnancy or breastfeeding;
- •Recent participation in any other interventional study in the past 30 days before enrollment;
- •Not expected to survive the follow-up period;
- •Inability to adhere to study procedures;
- •Any condition in which investigators believe that participating in this study may be harmful to the patient.
研究组 & 干预措施
Colchicine group
Patients in this arm will receiver oral colchicine 0.5mg once per day for 1 year combined with standard treatment
干预措施: Colchicine 0.5mg (Drug)
Placebo group
Patients in this arm will receiver oral matching placebo once per day for 1 year combined with standard treatment
干预措施: Matching placebo (Drug)
结局指标
主要结局
Incidence of treatment emergent adverse events (TEAE)
时间窗: Any time within 1 year
Incidence of treatment emergent adverse events (TEAE)
Frequency of participants who are adherence to medicine without permanent discontinuation due to TEAE until the end of follow-up.
时间窗: 1 year
Frequency of participants who are adherence to medicine without permanent discontinuation due to TEAE until the end of follow-up
次要结局
- Safety-Treatment-related adverse events (TRAE)(Any time within 1 year)
- Safety-TEAE according to Common Terminology Criteria for Adverse Events (CTCAE) grade ≥3(Any time within 1 year)
- Feasibility-Recruitment rate(1 year)
- Feasibility-Retention rate(1 year)
- Clinical efficacy-Recurrent symptomatic spontaneous lobar ICH(Any time within 1 year)
- Clinical efficacy-Composite of major adverse cardiovascular events (MACE)(Any time within 1 year)
- Clinical efficacy-Any individual MACE(Any time within 1 year)
- Clinical efficacy-Cognitive outcome(1 year)
- Clinical efficacy-Functional outcome(3-month, 6-month and 1-year)
- Clinical efficacy-Quality of life(1 year)
- Clinical efficacy-Blood inflammatory markers(6 month and 1 year)
- Radiological efficacy-New asymptomatic ICH lesion(1 year)
- Radiological efficacy-Severe cSS progression(1 year)
- Radiological efficacy-Any cSS progression(1 year)
- Radiological efficacy-CMB progression(1 year)
研究者
Xin Cheng
Professor and Vice Chair, Department of Neurology, Huashan Hospital, Fudan University
Huashan Hospital