Post-Ablation Pericarditis Reduction Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Proportion of patients with Pericarditis
研究概览
简要总结
There has not been a prospective, randomized controlled trial of colchicine to reduce post-AF ablation pericarditis in an era of newer AF ablation techniques. The hypothesis is that an empiric pre and post AF ablation treatment protocol with colchicine may reduce the incidence and symptom severity of post-AF ablation related pericarditis. Thus, the goal of this study is to
- Identify the incidence of post-AF ablation related pericarditis in patients undergoing ablation via high power, short duration strategy (shorter total RF time, but increased stability due to steerable catheters and possible difference from resistive vs conductive heating).
- Identify potential differences in patients undergoing PVI only versus PVI + additional ablation
- Identify whether patients on who are already on anti-inflammatories such as ASA or statins have a lower incidence than those without
- Determine if an empiric treatment strategy with colchicine (for 7 days post ablation) reduces the incidence of post-operative AF
详细描述
This study will be a prospective, randomized controlled study of 248 patients presenting to the electrophysiology lab at Ascension St. Vincent (Indianapolis, IN) and Ascension Sacred Heart (Pensacola, FL) for atrial fibrillation ablation. Cases will be randomized in sequential order.
The control arm will undergo standard of care, whereas the study arm will undergo treatment with colchicine 0.6mg PO BID for 7 days following ablation.
Study variables will consist of
- Patient demographics
o age, gender, comorbidities (HTN, HLD, DM-2, COPD, tobacco use, OSA, CKD, weight in kg, BMI, LVEF, autoimmune inflammatory condition such as RA), type of AF (paroxysmal, persistent, etc.)
- Medical therapy characteristics
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Patients unable to receive or tolerate colchicine
- •Pregnant or lactating women
- •Concomitant use of drugs interacting with colchicine (including: cyclosporin, ranolazine, tacrolimus, clarithromycin, indinavir, itraconazole, ketoconazole, nefazadone, ritonavir, saquinavir, suboxone, telithromycin, erythromycin, fluconazole, verapamil, diltiazem, or more than 1 glass grapefruit juice daily)
- •Severe renal impairment (CrCl < 30 mL/min)
- •Severe hepatic impairment (ALT/AST greater than 5x ULN or clinical cirrhosis)
- •Ongoing current use of colchicine.
研究组 & 干预措施
Colchicine
0.6mg colchicine oral twice daily for 7 days.
干预措施: Colchicine (Drug)
结局指标
主要结局
Proportion of patients with Pericarditis
时间窗: Postoperative day 30.
Clinical pericarditis ascertained by comprehensive chart review and a follow up phone call using a survey instrument.
次要结局
- Proportion of patients with recurrent Atrial fibrillation(Through study completion, an average of 1 year)
- Median rating of patient satisfaction on a Likert scale, comparing the study group and standard of care group.(Postoperative day 14)