A Prospective, Randomized, Double-Blind, Parallel-Group, Multicenter, Non-inferiority Study Comparing the Efficacy and Safety of Rivaroxaban (BAY 59-7939) With Warfarin for the Prevention of Stroke and Non-Central Nervous System Systemic Embolism in Subjects With Non-Valvular Atrial Fibrillation

BAYER S.A.,0 个研究点目标入组 0 人开始时间: 2007年6月21日最近更新: 2023年9月4日

适应症

试验速览

暂无简介。

•1. Men or women ≥18 years of age.
•2. Non-valvular atrial fibrillation documented on at least 2 occasions, the first must be 1 to 6 months before the screening visit and the second within 14 days prior to randomization
•3. History of ischemic stroke, TIA or systemic embolism outside the CNS considered of cardioembolic origin or with 2 or more risk factors.
•3. Women should be postmenopausal, sterile by surgical procedures, abstinent or, if sexually active, use an effective contraceptive method before entering the study and throughout it.
•4. Patients must have signed an informed consent stating that they understand the purpose of the study and the procedures it requires, and that they are willing to participate in the study.
•5. To participate in the optional pharmacogenetic component, patients must have signed the informed consent document.

•1. Hemodynamically significant mitral valve stenosis.
•2. Heart valve prosthesis.
•3. Planned cardioversion.
•4. Transient atrial fibrillation caused by a reversible disorder.
•5. Knowledge of the presence of atrial myxoma or left ventricular thrombus.
•6. Active endocarditis.
•7. Active internal bleeding.
•8. History of or condition associated with an increased risk of bleeding.
•9. Planned invasive procedure with the possibility of uncontrolled bleeding.
•10. Platelet count <90,000 / uL.
•11. Sustained hypertension not controlled.
•12. Disabling, severe stroke within 6 months or any stroke within 30 days prior to the randomization visit.
•13. Transient ischemic attack within the previous 3 days.
•14. Indication of anticoagulant treatment for a condition other than atrial fibrillation.
•15. Concomitant treatment with an oral or intravenous antiplatelet agent, use within the previous 5 days, concomitant treatment with a fibrinolytic agent, use within 10 days of randomization.
•16. Planned need for chronic treatment with a non-steroidal anti-inflammatory drug.
•17. Treatment with a potent inhibitor of cytochrome P450 isoenzyme 3A4.
•18. Anemia.
•19. Pregnancy or lactation matema.
•20. Any other contraindication to warfarin.
•21. HIV infection at the time of selection.
•22. CLcr calculated <30 mL / min.
•23. Significant liver disease or ALT> 3 x ULN.

发起方

BAYER S.A.,