Targeting Inflammation in Atrial Fibrillation to Prevent Ischemic Stroke: A Feasibility Study Evaluating the Effect of Colchicine on D-dimer and Hs-CRP in Anticoagulated Patients With Atrial Fibrillation
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Recruitment rates
研究概览
简要总结
The purpose of this study is to determine the feasibility of performing a randomized controlled trial to investigate the efficacy of an anti-inflammatory drug, colchicine, at reducing well validated markers of thrombosis (D-dimer) and inflammation (hs-CRP).
详细描述
Atrial fibrillation (AF), the most common cardiac arrhythmia (with a global burden of 33.5 million affected patients in 2010), is responsible for about 20% of ischemic stroke, a major cause of morbidity and mortality. Anticoagulants are very effective in reducing the risk of stroke in AF but on average 10-15% of treated patients still experience a stroke over a 10-year period and in selected elderly populations the risk is even higher. We hypothesize that thrombosis mediated by inflammation might be responsible for the residual risk of stroke, despite anticoagulant therapy and that targeting inflammation has the potential to reduce thrombosis and the risk of stroke in anticoagulated patients with AF.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with atrial fibrillation who has been receiving chronic anticoagulation for at least 3 months.
排除标准
- •Contraindications to colchicine such as allergy/hypersensitivity,
- •Receiving colchicine or other anti-inflammatory drugs (such as corticosteroids, methotrexate, anti-neoplastic, Interleukin 1-1b antagonist, Tumor necrosis factor-alpha inhibitor),
- •Receiving food or co-medications such as strong-moderate cytochrome P450 3A4 inhibitors that will result in elevated plasma level of colchicine,
- •Inflammatory disorders (SLE, Rheumatoid arthritis, connective tissue disorder) or chronic infection,
- •Severe renal (eGFR< 30ml/min/1.73m2), or liver failure or liver aminotransferase (ALT/AST > 2x Upper limit of normal),
- •Moderate or severe cytopenias (platelet < 100, neutrophil count < 1.5) or existing blood dyscrasia (e.g., myelodysplasia)
- •Pregnant or lactating woman or woman of child bearing age no protected by reliable contraception.
研究组 & 干预措施
Active Colchicine
The intervention group will receive colchicine 0.6 mg twice daily orally for 3 months
干预措施: Colchicine (Drug)
Placebo Colchicine
The control group will receive colchicine placebo 0.6mg twice daily orally for 3 months.
干预措施: Placebo (Drug)
结局指标
主要结局
Recruitment rates
时间窗: Randomization to Month 3
Number of eligible patients successfully randomized into study per year of study.
Drop-out rates
时间窗: Randomization to Month 3
Proportion of participants withdrawing from study for any reason
次要结局
- D-dimer(Randomization to Month 3)
- hs-CRP(Randomization to Month 3)
- Proportion of patients with a clinically significant adverse event(Randomization to Month 3)
- Drug adherence(Randomization to Month 3)
研究者
Noel Chan
PI
Population Health Research Institute