"Prospective Open Label Randomized Evaluation of Abbreviated Course of Dabigatran Etexilate With tranSesophageal echOcardiography (TEE) Control vs Conventional 3-week coUrse With dabigatraN Etexilate Before Cardioversion: Analysis of MRI-detecteD Cerebral Embolism" (RE-SOUND Study), № 1160.242
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- the proportion of patients with new magnetic resonance imaging (MRI) detected cerebral embolic events
研究概览
简要总结
The purpose of the study is to evaluate the efficacy of abbreviated 3-day anticoagulation with dabigatran etexilate before cardioversion guided by trans-oesophageal echocardiography in comparison with conventional 3- week course of dabigatran etexilate before cardioversion
详细描述
Current guidelines recommend for stroke prevention in patients with atrial fibrillation (AF) lasting more than 48 h designated for cardioversion standard approach with anticoagulation for a minimum 3 weeks before anticoagulation. The alternative is abbreviated anticoagulation in case of using trans-oesophageal echocardiography (TEE)-guided approach with quick cardioversion if no thrombus or high-grade spontaneous echo contrast is seen. There is currently no data on the direct comparison of efficacy and safety of conventional and abbreviated courses of non-vitamin K antagonist oral anticoagulants (NOAC) before cardioversion in AF.
The RE-SOUND study is prospective open label study with blinded outcome evaluation (PROBE design) multicenter active control trial comparing efficacy of 3-day abbreviated TEE-guided and conventional 3-week courses of NOAC dabigatran etexilate before cardioversion in adult patients with AF lasting more than 48 h
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
- Single (Outcomes Assessor)
盲法说明
Blinded evaluation of primary outcome by Imaging expert, who will made decision regarding achievement of primary outcome
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male and female subjects aged >18 years old and <75 years old
- •the diagnosis of non-valvular atrial fibrillation/atrial flutter duration of 48 hours or more (or unknown) documented by ECG. Duration of AF will be defined on the base of patient source documents
- •documented physician's decision to conduct electrical cardioversion
- •written informed consent form (ICF) signed by patient
排除标准
- •effective treatment with oral anticoagulants within the last 30 days
- •need in anticoagulant treatment for disorder other than AF
- •rheumatic heart disease
- •mitral stenosis of unknown origin
- •mechanic heart valve
- •acute coronary syndrome within 12 months
- •percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) surgery within the last 12 month or planned for the next 8 weeks
- •known hypersensitivity for dabigatran, dabigatran etexilate or to any of capsul's components
- •creatinine clearance <30 ml/min
- •active bleeding, haemorrhagic diathesis, coagulopathy
- •major surgery within the previous month, surgery planned for the next 8 weeks,
- •clinically relevant bleeding within the last 30 days
- •symptomatic or endoscopically documented gastroduodenal ulcers within the last 30 days
- •intracranial haemorrhages in medical history
- •organ damages resulted from clinically relevant bleeding within 6 months before randomization.
- •major trauma or any craniocerebral trauma within 30 days before randomization.
- •any cancer within last 5 years
- •uncontrolled hypertension (systolic blood pressure >180mm Hg and/or diastolic blood pressure >100 mmHg).
- •chronic heart failure (CHF) III-IV functional classes (by NYHA)
- •severe ischemic stroke within the last 12 month before randomization
- •changes of liver functions with alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >3 upper limit of normal (ULN)
- •liver disease having impact on survival
- •pregnancy and breast feeding. Women of child bearing potential must agree to the requirements for pregnancy testing and contraceptive methods
- •any contraindications for electric cardioversion (see attachment # 1 for details).
- •any contraindications to cerebral MRI
- •any contraindications to TEE ( perforated viscus; esophageal pathology (stricture, trauma, tumor, scleroderma, Mallory-Weiss tear, diverticulum); tracheoesophageal fistula; active upper GI bleeding; recent upper GI surgery; esophagectomy, esophagogastrectomy.)
- •patients who on the discretion of physician will not benefit from 150 BID dose of dabigatran during study course
- •active hepatitis
- •anemia (hemoglobin level <100g/L) or thrombocytopenia (platelet count <100 × 109/L)
- •alcohol abuse
- •hyperthyroidism
研究组 & 干预措施
Abbreviated course group (ACG)
The patients receiving 3-days course of dabigatran etexilate during pre-cardioversion period. After cardioversion has been performed the patients continue with dabigatran etexilate until 30 days after cardioversion
干预措施: dabigatran etexilate (Drug)
Conventional course group (CCG)
The patients receiving 3-weeks course of dabigatran etexilate before cardioversion of AF. After cardioversion has been performed the patients will continue with dabigatran etexilate until 30 days after cardioversion
干预措施: dabigatran etexilate (Drug)
结局指标
主要结局
the proportion of patients with new magnetic resonance imaging (MRI) detected cerebral embolic events
时间窗: 30 days after cardioversion
patients with new (not visible at pre-cardioversion MRI) cerebral ischemic lesions revealed at MRI after cardioversion and without a history of acute neurological dysfunction attributable to the lesion or with symptomatic cerebral ischemic stroke after cardioversion confirmed by MRI examination
次要结局
- the proportion of patients with at least one bleeding event since the first dose of dabigatran(from the first dose of dabigatran etexilate till 30th day after cardioversion)
- the proportion of patients with at least one major bleeding event since the first dose of dabigatran(from the first dose of dabigatran etexilate till 30th day after cardioversion)
- the proportion of patients with intracranial bleeding events since the first dose of dabigatran(from the first dose of dabigatran etexilate till 30th day after cardioversion)
- the incidence of symptomatic cerebral thromboembolic events (stroke or TIA)(within 30 days after cardioversion)
- the proportion of patients with major bleeding events after cardioversion(within 30 days after cardioversion)
- the proportion of patients with any bleeding events after cardioversion(within 30 days after cardioversion)
- the proportion of patients with intracranial bleeding events after cardioversion(within 30 days after cardioversion)
研究者
Vadim Grachev
Principal Investigator
Ural State Medical University