EUCTR2011-002234-39-DE进行中（未招募）不适用
A prospective, randomized, open-label, parallel-group, active-controlled, multicenter study exploring the efficacy and safety of once-daily oral rivaroxaban (BAY 59-7939) compared with that of dose-adjusted oral vitamin K antagonists (VKA) for the prevention of cardiovascular events in subjects with nonvalvular atrial fibrillation scheduled for cardioversion
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
- 1,500
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
- •Men or women aged = 18 years
- •Hemodynamically stable nonvalvular atrial fibrillation longer than 48 hours or of unknown duration
- •Scheduled for cardioversion (electrical or pharmacological) of nonvalvular atrial fibrillation
- •Written informed consent
- •Women of childbearing potential and men must agree to use adequate contraception when sexually active. This applies from the time of signing of the informed consent form until 30 days after the last study drug administration. The definition of adequate contraception will be based on the judgment of the investigator and local requirements. Acceptable methods of contraception include (i) condoms (male or female) with or without a spermicidal agent; (ii) diaphragm or cervical cap with spermicide; (iii) intrauterine device; and (iv) hormone-based contraception.
- •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 700
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 800
排除标准
- •Severe, disabling stroke (modified Rankin score of 4?5, inclusive; see Section 14.2) within 3 months or any stroke within 14 days before the randomization visit
- •Transient ischemic attack within 3 days prior to randomization
- •Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
- •Acute MI within the last 14 days prior to randomization
- •Cardiac-related criteria:
- •oKnown presence of left atrial/LAA thrombus before study inclusion
- •oKnown presence of atrial myxoma
- •oKnown left ventricular or aortic thrombus
- •oValvular heart disease (either hemodynamically significant mitral valve stenosis or prosthetic heart valve)
- •Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
- •Concomitant drugs/therapies:
- •oIndication for anticoagulant therapy for a condition other than atrial fibrillation (eg, VTE)
- •oChronic aspirin therapy > 100 mg daily or dual antiplatelet therapy
- •oConcomitant use of strong inhibitors of both cytochrome P450 (CYP) 3A4 and P-glycoprotein (P-gp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotic agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
- •Concomitant conditions:
- •oChildbearing potential without proper contraceptive measures, pregnancy, or breast feeding
- •oHypersensitivity to investigational treatment or comparator treatment
- •oCalculated CrCl < 30 mL/minute (see Section 14.1)
- •oHepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- •oAny severe condition that would limit life expectancy to less than 6 months (eg, advanced malignancy, etc.)
- •oPlanned invasive procedure with potential for uncontrolled bleeding, including major surgery or cardiac catheterization
- •oInability to take oral medication
- •oOngoing drug addiction or alcohol abuse
- •Any other contraindication listed in the local labeling for the comparator treatment or experimental treatment
- •Participation in a study with an investigational drug or medical device within 30 days prior to randomization
- •Previous randomization in this study
- •Inability to cooperate with the study procedures
研究者
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