JPRN-UMIN000015923已完成4 期
Safety and Effectiveness Trial of Apixaban Use in Association with Dual Antiplatelet Therapy in Atrial Fibrillation Patients Undergoing Percutaneous Coronary Intervention - SAFE-A
Cardiovascular Division, Faculty of Medicine, University of Tsukuba0 个研究点目标入组 210 人开始时间: 2015年1月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 210
研究概览
简要总结
Primary endpoint all bleeding: 1 month vs 6 months; 11.8% vs 16.0% (Log-rank, P=0.34) Secondary endpoint Composite events (all-cause death, myocardial infarction, stroke, systemic embolization): 1 month vs 6 months; 9.8% vs 2.8% (Log-rank, P=0.053) Net Clinical Benefit (all-cause death, myocardial infarction, stroke, systemic embolization, bleeding with BARC type 3 or higher): 1 month vs 6 months; 10.8% vs 5.7% (Log-rank, P=0.22)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20years-old 至 ot applicable（—）
- 性别
- All
入选标准
- 未提供
排除标准
- •1. Patients who cannot tolerate antiplatelets and anticoagulants 2. Patients after mechanical valve replacement 3. Patients in whom a stent has been placed in the left main trunk 4. Patients in whom stents have been placed in a bifurcated lesion by the two stent technique 5. Patients complicated with decompensated heart failure or cardiogenic shock 6. Patients complicated with advanced chronic kidney disease (creatinine clearance <15 ml/min) 7. Patients with a past history of intracranial hemorrhage 8. Patients with a past history of stent thrombosis 9. Patients for whom surgery (cardiac and noncardiac surgery) is scheduled 10. Patients for whom pulmonary vein isolation is scheduled 11. Patients with active hemorrhage 12. Patients with active malignant tumor 13. Patients with pregnancy 14. Patients who are not expected to live 1 year or longer 15. Patients deemed to be inappropriate as the subjects of this study by the investigator
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