EUCTR2021-005022-18-DE进行中（未招募）1 期
Anticoagulation for New-Onset Post-Operative Atrial Fibrillation after CABG - PACeS
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 3,200
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
- •1. Patients of age =18 years who undergo isolated CABG for coronary
- •artery disease
- •2. POAF that persists for >60 minutes or is recurrent (more than one
- •episode) within 7 days after the index CABG
- •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 1200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2000
排除标准
- •1. Clinical history of either permanent, persistent or paroxysmal atrial
- •fibrillation
- •2. Any pre-existing clinical indication for long-term OAC
- •3. Any absolute contraindication to OAC
- •4. Planned use of post-operative dual antiplatelet therapy (DAPT)
- •5. Cardiogenic shock
- •6. Major perioperative complication occurring between CABG and
- •randomization
- •7. Concomitant left atrial appendage closure during CABG
- •8. Concomitant valve surgery during CABG or prior valve surgery (including aortic,
- •mitral, tricuspid or pulmonary)
- •9. Concomitant mitral valve annuloplasty during CABG
- •10. Concomitant carotid artery endarterectomy during CABG
- •11. Concomitant aortic root replacement during CABG
- •12. Concomitant surgery for AF during CABG
- •13. Liver cirrhosis or Child-Pugh Class C chronic liver disease
- •14. Pharmacologic therapy with an investigational drug or device
- •within 30-days prior to randomization or plan to enroll patient in an
- •investigational drug or device trial during participation in this trial
- •15. Pregnancy at the time of randomization
- •16. Unable or unwilling to provide informed consent
- •17. Unable or unwilling to comply wit the study treatment and followup
- •18. Existence of underlying disease that limits life expectancy to less
- •than one year
- •Added for European Trial sites:
- •19. women of childbearing potential (within two years after the last
- •spontaneous menstruation) without effective contraceptive measures
- •(Implanon, injections, oral contraceptives, intrauterine devices,
- •vasectomized partner) during study participation.
- •(Participants using hormone-based preparations must be informed about possible
- •informed about possible interactions with the study medication).
- •be informed).
- •20. participation in other interventional studies
- •21. patients under legal supervision or guardianship.
研究者
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