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首页> 外文期刊>The American heart journal >Rationale and design of the colchicine for prevention of the post-pericardiotomy syndrome and post-operative atrial fibrillation (COPPS-2 trial): A randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation
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Rationale and design of the colchicine for prevention of the post-pericardiotomy syndrome and post-operative atrial fibrillation (COPPS-2 trial): A randomized, placebo-controlled, multicenter study on the use of colchicine for the primary prevention of the postpericardiotomy syndrome, postoperative effusions, and postoperative atrial fibrillation

机译：秋水仙碱预防心包切开术后综合征和术后房颤的原理和设计（COPPS-2试验）：一项随机，安慰剂对照，多中心研究，关于秋水仙碱在一级预防心包切开术后综合征中的应用，术后积液和术后房颤

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Background The efficacy and safety of colchicine for the primary prevention of the postpericardiotomy syndrome (PPS), postoperative effusions, and postoperative atrial fibrillation (POAF) remain uncertain. Although preliminary data from a single trial of colchicine given for 1 month postoperatively (COPPS trial) were promising, the results have not been confirmed in a large, multicenter trial. Moreover, in the COPPS trial, colchicine was given 3 days postoperatively. Methods The COPPS-2 study is a multicenter, double-blind, placebo-controlled randomized trial. Forty-eight to 72 hours before planned cardiac surgery, 360 patients, 180 in each treatment arm, will be randomized to receive placebo or colchicine without a loading dose (0.5 mg twice a day for 1 month in patients weighing ≥70 kg and 0.5 mg once for patients weighing <70 kg or intolerant to the highest dose). The primary efficacy end point is the incidence of PPS, postoperative effusions, and POAF at 3 months after surgery. Secondary end points are the incidence of cardiac tamponade or need for pericardiocentesis or thoracentesis, PPS recurrence, disease-related admissions, stroke, and overall mortality. Conclusions The COPPS-2 trial will evaluate the use of colchicine for the primary prevention of PPS, postoperative effusions, and POAF, potentially providing stronger evidence to support the use of preoperative colchicine without a loading dose to prevent several postoperative complications. ClinicalTrials.gov Identifier: NCT01552187.
机译：背景秋水仙碱在一级预防心包切开术后综合征（PPS），术后积液和术后房颤（POAF）方面的疗效和安全性尚不确定。尽管术后1个月进行秋水仙碱单项试验的初步数据（COPPS试验）是有希望的，但尚未在大型的多中心试验中证实结果。此外，在COPPS试验中，术后3天给予秋水仙碱。方法COPPS-2研究是一项多中心，双盲，安慰剂对照的随机试验。在计划的心脏手术前的48至72小时内，将有360名患者（每个治疗组中的180名患者）随机接受安慰剂或秋水仙碱，而无负荷剂量（体重≥70 kg和0.5 mg的患者每天两次0.5 mg，共1个月）体重<70 kg或对最大剂量不耐受的患者一次。主要疗效终点是术后3个月PPS，术后积液和POAF的发生率。次要终点是心脏压塞的发生率或需要进行心包穿刺或胸腔穿刺，PPS复发，疾病相关的入院率，中风和总体死亡率。结论COPPS-2试验将评估秋水仙碱在预防PPS，术后积液和POAF方面的初步应用，可能提供更强有力的证据来支持在无负荷剂量的情况下使用术前秋水仙碱以预防多种术后并发症。 ClinicalTrials.gov标识符：NCT01552187。

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