Treatment and Prevention of Pericarditis With Colchicine. A Multicenter Double Blind Randomized Trial. The ICAP Trial: Investigation on Colchicine for Acute Pericarditis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Recurrence rate at 18 months
研究概览
简要总结
The purpose of the study is to determine whether colchicine is safe and effective in the treatment of acute pericarditis and the prevention of subsequent recurrences.
详细描述
Colchicine is safe and effective in the management of recurrent pericarditis after failure of conventional treatment. Preliminary data have shown that it may be effective also in treatment of the index attack of pericarditis and the prevention of further recurrences.
Comparisons: The study will compare the safety and efficacy of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences. Colchicine will be used in addition to conventional treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with acute pericarditis (index attack)
- •Age≥ 18 years
- •Informed consent
排除标准
- •Suspected neoplastic, tuberculous, or purulent etiology
- •Known severe liver disease and/or elevated transaminases >1.5 times the upper limit of normality
- •Serum creatinine >2.5 mg/dl
- •Serum creatine kinase (CK) over the upper limit of normality or known myopathy
- •Known gastrointestinal or blood disease
- •Pregnant or lactating women or women not protected by a contraception method
- •Known hypersensibility to colchicine
- •Treatment with colchicine at enrolment
研究组 & 干预措施
Placebo
Conventional therapy plus placebo
干预措施: Placebo (Drug)
Colchicine
Conventional therapy plus colchicine
干预措施: Colchicine (for 3 months) (Drug)
结局指标
主要结局
Recurrence rate at 18 months
时间窗: 18 months
次要结局
- Time to first recurrence(18 months)
- Disease-related re-hospitalization, cardiac tamponade, constrictive pericarditis within the duration of the study(18 months)
- Symptom persistence at 72 hours, remission rate at 1 week(1 week)
- Number of recurrences(18 months)