Colchicine for Patients With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement (Co-STAR): a Randomized-controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Incidence rate of the composite of new onset atrial fibrillation or occurrence of conduction disturbances requiring the implantation of a permanent pacemaker
研究概览
简要总结
Transcatheter aortic valve implantation (TAVI) is a well-established alternative to surgical aortic valve replacement for the treatment of patients with symptomatic severe aortic stenosis. While peri-procedural complications such as stroke, vascular complications and bleeding have substantially declined with the refinement of transcatheter valves and increasing experience, new-onset atrial fibrillation (NOAF) or atrioventricular conduction disturbances continue to occur in almost half of all patients.
Colchicine is a well-known substance that has been approved for the treatment of acute gout flares and familial Mediterranean fever in many countries. Colchicine has proven safe and effective in the prevention of atrial fibrillation after cardiac surgery. The anti-inflammatory effects of colchicine may mitigate the occurrence of atrioventricular conduction disturbances and thus the need for the implantation of a permanent pacemaker post transcatheter aortic valve implantation.
The objective of the Co-STAR-Trial is to investigate the efficacy of colchicine for the prevention of new-onset atrial fibrillation and conduction disturbances requiring the implantation of a permanent pacemaker in patients undergoing transcatheter aortic valve implantation.
Co-STAR is an investigator-initiated, randomized, double blind, placebo-controlled trial. A total of 200 patients referred for treatment of symptomatic severe aortic stenosis and selected to undergo TAVI will be randomized in a 1:1 ratio to the treatment with Colchicine or placebo for 30 days post transcatheter aortic valve implantation.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 65 years
- •Symptomatic severe aortic stenosis defined by an aortic valve area (AVA) ≤1.0 cm2 or an AVA indexed to body surface area <0.6cm2/m2
- •Selected to undergo transfemoral TAVI based on heart team decision
排除标准
- •Life expectancy <1 year irrespective of valvular heart disease
- •Kidney disease with a creatinine clearance ≤30 ml/min
- •Known severe liver disease
- •Known neuromuscular disease
- •Clinically significant anaemia with haemoglobin <80g/L
- •Known inflammatory bowel disease or chronic diarrhea
- •Known ongoing bacterial infection
- •Known galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- •Current treatment with colchicine, steroids or biologicals for any indication
- •Concomitant intake of Cyclosporine, Amiodarone, Clarithromycin, Erythromycin, Omeprazole, Verapamil or other strong inhibitors of CYP3A4 or P-Glycoprotein
- •Concomitant intake of Carbamazepin, Phenobarbital, Phenytoin, Rifampicin or other strong inductors of CYP3A4 and P-Glycoprotein
- •Permanent pacemaker or implantable cardioverter defibrillator
- •History of atrial fibrillation
- •Absence of sinus rhythm on hospital admission
- •Planned non-cardiac surgery within 30 days
- •Known intolerance to colchicine
- •Inability to provide written informed consent
- •Known or suspected non-compliance, drug or alcohol abuse
- •Participation in another clinical trial with an active intervention
- •Any other planned cardiac intervention performed in the 7 days before TAVI, concomitantly with TAVI or in the 30 days after TAVI except for percutaneous coronary interventions.
研究组 & 干预措施
Placebo
干预措施: Placebo (Drug)
Colchicine
干预措施: Colchicine (Drug)
结局指标
主要结局
Incidence rate of the composite of new onset atrial fibrillation or occurrence of conduction disturbances requiring the implantation of a permanent pacemaker
时间窗: 30 days
Assessed based on extended rhythm monitoring performed until 7 days post-discharge as well as clinically or incidentally captured episodes of NOAF captured during routine care thereafter. NOAF is defined as at least one episode of atrial fibrillation with a duration \>30s.
次要结局
- The incidence of conductance disturbances(30 days, 1 year)
- The predictors of conductance disturbances(30 days, 1 year)
- The incidence of new arrhythmias resulting in hemodynamic instability or requiring therapy(30 days, 1 year)
- Inflammatory marker levels(at day 1)
- Single components of primary composite endpoint(30 days and 1 year)
- The proportion of prosthetic leaflets with > 50% motion reduction or leaflet thickening(30 days)
- The incidences of major clinical adverse events(30 days, 1 year)
- The proportion of patients with at least one prosthetic leaflet with > 50% motion reduction or with at least one prosthetic leaflet with thickening(30 days)