Prevention of Silent Cerebral Thromboembolism by Oral Anticoagulation With Dabigatran After Pulmonary Vein Isolation for Atrial Fibrillation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 19
- 主要终点
- Incidence of new micro- and macro-embolic lesions on cerebral MRI incl. flare and diffusion weighted imaging 12 months after randomization compared to baseline MRI (3 months after AF catheter ablation)
研究概览
简要总结
Oral anticoagulation treatment (OAC) following clinically successful catheter abla-tion of atrial fibrillation (AF) is controversial. Recent guidelines recommended con-tinuation of OAC in all patients with CHA2DS2VASc score ≥2 even if there is no evidence of recurrent AF (Camm JA et al., Eur Heart J 2012). The net clinical ben-efit of OAC after successful ablation in these patients remains to some extent un-clear. As OAC bears the risk of bleeding events, the ODIn-AF study aims to evalu-ate the positive effect of OAC on the incidence of silent cerebral embolic events in patients with a high risk for embolic events, free from AF after successful pulmo-nary vein ablation. ODIn-AF aims to determine that continued administration of dabigatran is superior in the preven-tion of silent cerebral embolism to discontinuation of OAC after 3 months in pa-tients free from symptomatic AF-episodes with a CHA2DS2VASc score ≥2 after the first pulmonary vein ablation for paroxysmal AF.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Oral Anticoagulation with Dabigatran
The recommended daily dose of Pradaxa is 300 mg taken as one 150 mg capsule twice daily.
For the following patients the recommended daily dose of Pradaxa is 220 mg taken as one 110 mg capsule twice daily:
- Patients aged 75 years or above
- Cr-Cl 30-50 ml/min
- Patients who receive concomitant verapamil
For the following groups, the daily dose of Pradaxa of 300 mg or 220 mg should be selected based on an individual assessment of the thromboembolic risk and the risk of bleeding:
- Patients with moderate renal impairment
- Patients with gastritis, esophagitis or gastroesophageal reflux
- Other patients at increased risk of bleeding
干预措施: Dabigatran (Drug)
结局指标
主要结局
Incidence of new micro- and macro-embolic lesions on cerebral MRI incl. flare and diffusion weighted imaging 12 months after randomization compared to baseline MRI (3 months after AF catheter ablation)
时间窗: 12 months
次要结局
- Incidence of other thrombotic or thrombo-embolic events (myocardial in-farction, deep vein thrombosis, pulmonary embolism)(12 months)
- Life-threatening / major / minor bleedings(12 months)
- Location, size and number of new micro- and macro-embolic lesions on cerebral MRI(12 months)
- Severity of neurological deficits assessed by Modified Rankin Scale(12 months)
- All-cause mortality / Cardiovascular mortality(12 months)
- Correlation of cardio-embolic events to method used for PVI (cryo-balloon versus RF)(12 months)
- Correlation of cardio-embolic events with arrhythmia recurrence (atrial fi-brillation or atrial flutter post ablationem with ECG documentation or symp-toms)(12 months)
- Quality of life questionnaire (AF-specific symptoms, SF36)(12 months)
- Neuropsychological questionnaire (RBANS A&B)(12 months)
- Assessment of neurocognitive deficits: Minimental Test(12 months)
- Incidence of clinically evident cardio-embolic events (stroke, TIA, systemic embolism)(12 months)
- Hemorrhagic cerebral infarction(12 months)
研究者
Georg Nickenig
Prof.
University Hospital, Bonn