Impact and Time Course of Colchicine Therapy on C-reactive Protein Elevation in Chronic Atrial Fibrillation (AF) and Post AF Ablation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Change in C-reactive Protein
研究概览
简要总结
Colchicine will lower C-reactive protein (CRP) in chronic atrial fibrillation and reduce the rise in CRP which occurs following atrial fibrillation ablation
详细描述
Three groups of patients will be randomized to colchicine 0.6 mg PO bis in die (BID) or matching placebo:
- Paroxysmal atrial fibrillation, pre-ablation
- Persistent atrial fibrillation, pre-ablation
- Chronic persistent 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Group 1: Persistent or chronic AF presenting for evaluation in cardiology offices. Diagnosis of AF will be made based on the 12 -lead surface ECG.
- •Group 2: Paroxysmal AF scheduled to go AF ablation presenting to the electrophysiology laboratory for the procedure in sinus rhythm..
- •Group 3:Chronic AF scheduled to go clinically indicated AF ablation, and presenting in the electrophysiology laboratory in atrial fibrillation .
排除标准
- •Abnormal liver function with elevated enzymes> 1.5 times the normal.
- •Abnormal kidney function with glomerular filtration rate < 50 ml/min
- •Increased levels of creatine kinase or known myopathy
- •Neutropenia
- •Known GI disorders
- •Women of childbearing age who have not had surgical sterilization and are not using oral contraceptives, or who's spouse has not had surgical sterilization will be excluded due to the length of the trial and the possibility that they could become pregnant after entry.
- •Pregnant and lactating women
- •Lactose intolerance
- •Known sensitivity, allergy, or contraindication to colchicine use
研究组 & 干预措施
Chronic atrial fibrillation, colchicine
Colchicine 0.6 mg PO BID. Subjects not undergoing ablation.
干预措施: Colchicine, 0.6 mg PO BID (Drug)
Chronic atrial fibrillation, placebo
Matching placebo. Subjects not undergoing ablation.
干预措施: Matching placebo (Drug)
Pre-ablation, sinus rhythm, colchicine
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
干预措施: Colchicine, 0.6 mg PO BID (Drug)
Pre-ablation, sinus rhythm, placebo
Matching placebo. Subjects undergoing ablation.
干预措施: Matching placebo (Drug)
Pre-ablation, AF, colchicine
Colchicine 0.6 mg PO BID. Subjects undergoing ablation.
干预措施: Colchicine, 0.6 mg PO BID (Drug)
Pre-ablation, AF, placebo
Matching placebo. Subjects undergoing ablation.
干预措施: Matching placebo (Drug)
结局指标
主要结局
Change in C-reactive Protein
时间窗: baseline, day 28
Plasma levels of C-reactive protein was determined by the immunoprecipitation method using an in vitro diagnostic assay.
次要结局
- Number of Subjects With Atrial Fibrillation(day 28)
- Time Course of C-reactive Protein Levels(baseline, day 3, day 7, day 14, day 28)
研究者
Joseph L. Blackshear
Principal Investiator
Mayo Clinic