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临床试验/NCT04078568
NCT04078568已完成3 期

Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease: A Multicentre Randomised Controlled Trial

Children's Hospital of Fudan University66 个研究点 分布在 1 个国家目标入组 3,208 人开始时间: 2020年1月15日最近更新:
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适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
入组人数
3,208
试验地点
66
主要终点
Percentage of coronary artery lesions(CAL) at one month of illness
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This study evaluates the efficacy of the addition of prednisolone to conventional initial treatment (intravenous immunoglobulin [IVIG] plus aspirin) in reducing coronary artery lesion in children with Kawasaki disease (KD) .

详细描述

This is a multicenter, open-label, blind-endpoints, randomized controlled trial at more than 10 hospitals in China. The investigators enrolled KD children diagnosed within 10 days of onset. Participants will be randomly assigned in a 1:1 ratio to the control group (receiving 2g/kg IVIG and 30 mg/kg aspirin) or the intervention group (receiving 2 g/kg IVIG, 30 mg/kg aspirin and additional 2 mg/kg prednisolone). Baseline characteristics of each participant will be collected, including sex, age of onset, height, body weight, subtype of KD, fever days before initial IVIG, echocardiographic findings at enrolment, and a series of pre-IVIG laboratory tests. Two-dimensional echocardiography will be performed at admission, 2 weeks, 1 month, 3 months, 6 months，and 12 months after onset of KD to assess the coronary artery lesions.

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

Participants and physicians will not be masked to the assignment. Pediatric cardiologists who assess coronary artery lesions (CAL) by echocardiography will be masked to the allocation.

入排标准

年龄范围
1 Month 至 —（Child, Adult, Older Adult）
性别
All
接受健康志愿者
否

入选标准

  • •Meeting diagnostic criteria for Kawasaki disease (KD) released by American Heart Association (AHA) in 2017
  • •Diagnosed before the tenth day of illness (with the first day of illness defined as the first day of fever)
  • •Not treated with IVIG yet
  • •Age ≥1 month

排除标准

  • •Z score of any coronary artery before initial treatment ≥10
  • •Receiving steroids or other immunosuppressive agents in the previous 30 days
  • •With a previous history of KD
  • •Afebrile before enrolment
  • •With suspected infectious diseases including sepsis, septic meningitis, peritonitis, bacterial pneumonia, varicella and influenza
  • •With serious immune diseases such as immunodeficiency or chromosomal abnormalities

研究组 & 干预措施

the standard group

Active Comparator
  1. IVIG 2g/kg once, given within 12 to 24 hours;
  2. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.

干预措施: IVIG (Drug)

the standard group

Active Comparator
  1. IVIG 2g/kg once, given within 12 to 24 hours;
  2. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.

干预措施: Aspirin (Drug)

the standard+prednisolone group

Experimental
  1. IVIG 2g/kg once, given within 12 to 24 hours;
  2. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
  3. Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses) for 3 days, which is administered concurrently with the initial IVIG infusion and completed within 30-60 minutes, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days . If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.

干预措施: IVIG (Drug)

the standard+prednisolone group

Experimental
  1. IVIG 2g/kg once, given within 12 to 24 hours;
  2. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
  3. Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses) for 3 days, which is administered concurrently with the initial IVIG infusion and completed within 30-60 minutes, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days . If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.

干预措施: Aspirin (Drug)

the standard+prednisolone group

Experimental
  1. IVIG 2g/kg once, given within 12 to 24 hours;
  2. Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and CRP is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
  3. Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses) for 3 days, which is administered concurrently with the initial IVIG infusion and completed within 30-60 minutes, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days . If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.

干预措施: Prednisolone (Drug)

结局指标

主要结局

Percentage of coronary artery lesions(CAL) at one month of illness

时间窗: at one month of illness

Two-dimensional echocardiography will be performed to evaluate CAL at 1 month of illness. The measurement of each patient included the diameter of the left main coronary artery (LMCA), the left anterior descending artery (LAD), the left circumflex coronary artery (LCX), and the proximal and middle segments of the right coronary artery (RCA). Z score of each coronary artery will be calculated（Journal of the American Society of Echocardiography, 2011, 24(1).）. CAL is defined as z≥2of any coronary artery of LMCA, LAD, LCX, and the proximal and middle segment of the RCA.

次要结局

  • Occurrence of medium-to-giant coronary artery aneurysms (CAAs)(from admission to 12 months of illness onset)
  • Occurrence of large/giant CAAs(from admission to 12 months of illness onset)
  • Occurrence of CAL progression within 3 months of illness onset(from admission to 3 months of illness onset)
  • Changes in absolute diameter of LMCA throughout the study period(from admission to 12 months of illness onset)
  • Changes in absolute diameter of the proximal segment of RCA throughout the study period(from admission to 12 months of illness onset)
  • Percentage of the need for additional treatment(from admission to discharge (about 2 weeks of illness))
  • Duration of fever (hours) after initiation of initial IVIG infusion(from initiation of initial IVIG infusion to the first record of being afebrile(defined as an axillary temperature <37.5 for more than 24 hours))
  • Changes in z scores of LMCA throughout the study period(from admission to 12 months of illness)
  • Changes in z scores of LAD throughout the study period(from admission to 12 months of illness)
  • Changes in z scores of LCX throughout the study period(from admission to 12 months of illness)
  • Changes in z scores of the proximal segment of RCA throughout the study period(from admission to 12 months of illness)
  • Changes in absolute diameter of the middle segment of RCA throughout the study period(from admission to 12 months of illness onset)
  • Changes in z scores of the middle segment of RCA throughout the study period(from admission to 12 months of illness)
  • Change in serum C-reactive protein (CRP) concentration(from admission to 72 hours after completion of initial IVIG infusion)
  • Number of patients with serious adverse events(from admission to 3 months of illness)
  • Percentage of the need for additional treatment(from admission to discharge (about 2 weeks of illness))
  • Duration of fever (hours) after initiation of initial IVIG infusion(from initiation of initial IVIG infusion to the first record of being afebrile(defined as an axillary temperature <37.5 for more than 24 hours))
  • Changes in z scores of LMCA throughout the study period(from admission to 12 months of illness)
  • Changes in z scores of LAD throughout the study period(from admission to 12 months of illness)
  • Changes in z scores of LCX throughout the study period(from admission to 12 months of illness)
  • Changes in z scores of the proximal segment of RCA throughout the study period(from admission to 12 months of illness)
  • Changes in z scores of the middle segment of RCA throughout the study period(from admission to 12 months of illness)
  • Change in serum C-reactive protein (CRP) concentration(from admission to 72 hours after completion of initial IVIG infusion)
  • Number of patients with serious adverse events(from admission to 3 months of illness)
  • Occurrence of medium-to-giant coronary artery aneurysms (CAAs)(from admission to 12 months of illness onset)
  • Occurrence of large/giant CAAs(from admission to 12 months of illness onset)
  • Occurrence of CAL progression within 3 months of illness onset(from admission to 3 months of illness onset)
  • Changes in absolute diameter of LMCA throughout the study period(from admission to 12 months of illness onset)
  • Changes in absolute diameter of LAD throughout the study period(from admission to 12 months of illness onset)
  • Changes in absolute diameter of LCX throughout the study period(from admission to 12 months of illness onset)
  • Changes in absolute diameter of the proximal segment of RCA throughout the study period(from admission to 12 months of illness onset)
  • Changes in absolute diameter of the middle segment of RCA throughout the study period(from admission to 12 months of illness onset)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (66)

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