EUCTR2012-001484-79-BE进行中（未招募）不适用
A Randomized, Open-label, Active-controlled Multi-center Study to Evaluate the Safety of Rivaroxaban and Vitamin K Antagonists in Subjects Undergoing Catheter Ablation for Atrial Fibrillation - VENTURE-AF
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Have a documented history of paroxysmal (lasting <1 week), persistent (lasting >1 week and <1 year or requiring pharmacological or electrical cardioversion), or long standing persistent (= 1 year) NVAF.
- •Be scheduled for a catheter ablation procedure for NVAF.
- •Be willing and able to adhere to the prohibitions and restrictions specified in this protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 147
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 103
排除标准
- •Has contraindications to the use of any anticoagulant therapy (eg, bleeding diathesis, history of gastrointestinal bleeding within 1 year or coagulopathy or a platelet count <90,000/µL documented at screening).
- •Has a history of a major bleeding or thromboembolic event within the 12 months immediately preceding the catheter ablation procedure.
- •Has a history of a prior stroke, TIA or non-convulsive status epilepticus within 6 months of the screening visit.
- •Has a CrCl = 50 mL/min at screening
- •Has moderate to severe hepatic impairment (Child-Pugh B and C).
- •Has a comorbid condition such as severe pulmonary disease, infection, etc., and a life expectancy of less than 6 months.
研究者
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