NCT01552187Unknown3 期
COlchicine for Prevention of the Post-pericardiotomy Syndrome and Post-operative Atrial Fibrillation (COPPS-2 Trial).
Maria Vittoria Hospital1 个研究点 分布在 1 个国家目标入组 360 人开始时间: 2012年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence
研究概览
简要总结
This is a multicenter, double-blind, randomized trial to assess the efficacy and safety of colchicine for post-pericardiotomy syndrome prevention, post-operative effusions prevention, and post-operative atrial fibrillation prevention.
详细描述
This is a multi center, double-blind, randomized trial to test the efficacy and safety of colchicine for prevention of post-pericardiotomy syndrome, post-operative effusions, and post-operative atrial fibrillation.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18years
- •Candidate to cardiac surgery but cardiac transplantation
- •Informed consent
排除标准
- •Atrial fibrillation
- •Candidate to cardiac transplantation
- •Severe liver disease or elevation of serum transaminases (> 1.5 times the upper reference limit)
- •Serum creatinine > 2.5 mg/dL
- •Preoperative elevation of CK or known myopathy
- •Known chronic intestinal diseases or blood dyscrasias
- •Pregnancy, Lactation or Women of childbearing potential not protected by a contraception method
- •Hypersensitivity to colchicine
- •Treatment with colchicine for any cause
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
Colchicine
Active Comparator
Colchicine
干预措施: Colchicine (Drug)
结局指标
主要结局
Post-pericardiotomy syndrome, post-operative effusions, post-operative atrial fibrillation incidence
时间窗: 3 months
Incidence of the outcomes at 3 months from cardiac surgery
次要结局
- Cardiac Tamponade or Need for Pericardiocentesis(3 months)
- Need for thoracentesis(3 months)
- Re-admission(3 months)
- Overall mortality(3 months)
- Stroke incidence(3 months)
- Recurrence of the post-pericardiotomy syndrome(3 months)
研究者
Massimo Imazio
Principal Investigator
Maria Vittoria Hospital
研究点 (1)
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