EUCTR2017-003836-35-ES进行中（未招募）1 期
Colchicine For The Prevention Of Perioperative Atrial Fibrillation In Patients Undergoing Thoracic Surgery (COP-AF) - COP-AF
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 2,800
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •All patients undergoing thoracic surgery with general anesthesia are eligible for the trial if they are =55 years of age at the time of randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 980
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1820
排除标准
- •We will exclude patients who meet any of the following criteria:
- •1.Patients with a prior history of documented AF;
- •2.Patients currently taking anti-arrhythmic medication;
- •3.Patients undergoing minor thoracic interventions/procedures;
- •4.Patients with contraindications to colchicine;
- •5.Patients not expected to take oral medications for >24 hours after surgery;
- •6.Patients scheduled for lung transplantation;
- •7.Patients currently taking non-study colchicine before surgery;
- •8.Patients with severe hepatic dysfunction;
- •9.Patients with aplastic anemia,
- •10.Women of childbearing age who are not taking an effective form of birth control,
- •11.Patients who took within the last 14 days or scheduled to take during the first 10 days after surgery clarithromycin, erythromycin, telithromycin, cyclosporine, ketoconazole or itraconazole; OR
- •12.HIV patients treated with antiretroviral therapy.
研究者
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