Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD CAA prevention (KD-CAAP) trial protocol.
Multi-centre, randomised, open-label, blinded endpoint assessed, trial of corticosteroids plus intravenous immunoglobulin (IVIG) and aspirin, versus IVIG and aspirin for prevention of coronary artery aneurysms (CAA) in Kawasaki disease (KD): the KD CAA prevention (KD-CAAP) trial protocol.
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多中心，随机，开放标签，盲目端点评估，皮质类固醇以及静脉内免疫球蛋白（IVIG）和阿司匹林的试验，与IVIG和IVIG和阿司匹林预防冠状动脉动脉瘤（CAA）在川崎病（KD CAA疾病）中： （KD-CAAP）试验方案。
作者：
川崎病（Kawasaki disease， KD）是一种急性自限性炎症性血管炎，主要累及中等动脉，尤其是冠状动脉。最近在不同欧洲国家进行的一些研究表明，尽管静脉注射免疫球蛋白（IVIG）治疗，冠状动脉并发症的发生率仍高得惊人。这些高并发症发生率现在强调了迫切需要重新评估IVIG作为KD唯一主要治疗剂的必要性。川崎病CAA预防（KD- caap）试验将检验立即辅助皮质类固醇治疗标准护理IVIG和阿司匹林将降低欧洲未选择的KD患者冠状动脉动脉瘤（CAA）发生率的假设。KD-CAAP是一项多中心、随机、对照、开放标签、盲法终点评估试验，将由conect4儿童泛欧临床试验网络支持在欧洲进行。符合资格标准的KD患者将被随机分配（1:1），接受口服强的松龙2mg /kg/天加标准护理治疗IVIG （2g /kg）和阿司匹林（40mg /kg/天）；或者单独服用IVIG和阿司匹林进一步的治疗取决于温度和c反应蛋白（CRP）的反应。共同主要结局如下：(i)试验随访3个月内的任何CAA；（ii）经抢救治疗调整后第1、2和6周冠状动脉z评分最大值的平均估计值。其他结果将被评估，包括成本效益、生活质量、皮质类固醇毒性和其他安全性结果。最近的几项研究表明，欧洲与KD相关的冠状动脉并发症比IVIG早期试验最初提出的要高得多。KD- caap通过探索辅助皮质类固醇在未选择的KD病例中的治疗益处，直接解决了这一问题。如果我们发现皮质类固醇可以预防CAA并且是安全的，这是一种廉价且广泛可用的干预措施，可以立即实施，造福儿童。ISRCTN71987471- 2020年3月31日；Eudract 2019-004433-17。
Kawasaki disease (KD) is an acute self-limiting inflammatory vasculitis affecting predominantly medium-sized arteries, particularly the coronary arteries. A number of recent studies conducted in different European countries have demonstrated alarmingly high coronary complications despite treatment with intravenous immunoglobulin (IVIG). These high complication rates now emphasize the need for an urgent reappraisal of IVIG as the sole primary therapeutic agent for KD. The Kawasaki disease CAA prevention (KD-CAAP) trial will test the hypothesis that immediate adjunctive corticosteroid treatment to standard of care IVIG and aspirin will reduce coronary artery aneurysm (CAA) rates in unselected KD patients across Europe. KD-CAAP is a multicentre, randomised, controlled, open-label, blinded endpoint assessed trial that will be conducted across Europe supported by the conect4children pan-European clinical trials network. Patients with KD who satisfy the eligibility criteria will be randomised (1:1) to receive either oral prednisolone 2 mg/kg/day plus standard of care therapy IVIG (2 g/kg) and aspirin (40 mg/kg/day); or IVIG and aspirin alone. Further management is dictated by temperature and C-reactive protein (CRP) responses. Co-primary outcomes are as follows: (i) any CAA within the 3 months of trial follow-up; (ii) average estimate of maximum coronary Z-score at weeks 1, 2 and 6 adjusting for rescue treatment. Additional outcomes will be assessed including cost effectiveness, quality of life, corticosteroid toxicity and other safety outcomes. Several recent studies have indicated that coronary complications associated with KD across Europe are much higher than early trials of IVIG had initially suggested. KD-CAAP directly addresses this issue by exploring the therapeutic benefit of adjunctive corticosteroids in unselected KD cases. If we find that corticosteroids prevent CAA and are safe, this is a cheap and widely available intervention that could be implemented immediately for the benefit of children. ISRCTN71987471- March 31, 2020; Eudract 2019–004433-17.
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影响因子：
37.8
作者：
Kobayashi, Tohru;Inoue, Yoshinari;Morikawa, Akihiro
通讯作者：
Morikawa, Akihiro
影响因子：
158.5
作者：
Newburger, Jane W.;Sleeper, Lynn A.;Sundel, Robert P.
通讯作者：
Sundel, Robert P.
川崎病的治疗。
影响因子：
5.2
作者：
Eleftheriou D;Levin M;Shingadia D;Tulloh R;Klein NJ;Brogan PA
通讯作者：
Brogan PA
DOI：
10.1093/rheumatology/keaa652
发表时间：
2021-02-01
期刊：
Rheumatology (Oxford, England)
影响因子：
--
作者：
Papadopoulou C;Al Obaidi M;Moraitis E;Compeyrot-Lacassagne S;Eleftheriou D;Brogan P
通讯作者：
Brogan P
影响因子：
5
作者：
Brogan, Paul;Naden, Ray;Stone, John H.
通讯作者：
Stone, John H.