JPRN-UMIN000013129已完成未知
A prospective,multi-center,parallel-group comparison study to evaluate safety and efficacy of dabigatran during the perioperative period in patients with non-valvular atrial fibrillation who undergo the catheter ablation compared to walfarin - Ablation perioperative dabigatran in use Envisioning in Japan(ABRIDGE-J)
Research group of anticoagulation therapy for NVAF ablation0 个研究点目标入组 450 人开始时间: 2014年2月14日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 85years-old（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1_Patients who have a history of hypersensitivity to any ingredients of dabigatran or walfarin preparation 2_Patients who are suffering from severe renal disorder (creatinine clearance<30 mL/min) including hemodialysis patients 3_Patients who have hemorrhagic symptoms (thrombocytopenic purpura, bleeding tendency caused by vascular defect,hemophilia and other impaired blood coagulation,menstrual period,at the time of operation,gastrointestinal tract ulcer,urinary tract bleeding, hemoptysis, abortion and premature birth, puerperant associated with genital bleeding and intracranial bleeding), hemorrhagic diathesis and hemostatic disorder 4_Patients who have any organic lesion posing a clinically important risk for bleeding (including the onset of hemorrhagic stroke within the past 6 months) 5_Patients who are placing a spinal/epidural catheter 6_Patients who are receiving(oral) itraconazole 7_Patients who are pregnant and of child-bearing potential, patients who are breast-feeding or patients who want to get pregnant during the study period 8_Patients who are of bleeding potential (visceral tumor, gastrointestinal diverticulitis, colitis, subacute bacterial endocarditis, severe hypertension, severe diabetes etc.) 9_Patients who have a severe hepatic impairment 10_Patients who underwent the central nervous system operation or suffered from injury with a short history 11_Patients who are receiving vitamin K2 for osteoporosis 12_Patients who are receiving iguratimod 13_Patients who undergo an operation or bloody maneuver except the ablation 14_Patients whom the investigator judges as inappropriate subjects
研究者
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