EUCTR2011-002234-39-ES进行中（未招募）1 期
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 antagonist (VKA) for the prevention of stroke and non-central nervous system systemic embolism in subjects with non-valvular atrial fibrillation scheduled for cardioversion
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
- 1,584
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
入选标准
- •Subjects must meet the following criteria to be enrolled in the study:
- •-Men or women aged >=18 years
- •-Hemodynamically stable non-valvular atrial fibrillation >48 hours or non-valvular atrial fibrillation of unknown duration
- •-Scheduled for cardioversion (electrical or pharmacological) of atrial fibrillation
- •-Provide 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.
- •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
- •Subjects who meet any of the following criteria will be excluded from enrollment in the study:
- •-Any stroke within the last 14 days prior to randomization
- •-Transient ischemic attack within 3 days before randomization
- •-Acute clinical signs of systemic thromboembolic events or thrombosis within the last 14 days prior to randomization
- •-Acute MI within the last 14 days prior to randomization
- •-Cardiac-related criteria:
- •o Known presence of left atrial thrombus before study inclusion
- •o Known presence of atrial myxoma
- •o Known left ventricular or aortic thrombus
- •o Valvular 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:
- •o Indication for anticoagulant therapy for a condition other than atrial fibrillation (eg, VTE)
- •o Pretreatment with new anticoagulant drugs, such as factor IIa or factor Xa inhibitors, within 30 days prior to randomization
- •o Aspirin >100 mg or dual antiplatelet therapy
- •o Concomitant use of strong inhibitors of both cytochrome P450 (CYP)-3A4 and P-glycoprotein (Pgp), ie, all human immunodeficiency virus protease inhibitors and the following azole antimycotic agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically
- •-Concomitant conditions:
- •o Childbearing potential without proper contraceptive measures, pregnancy, or breast feeding
- •o Hypersensitivity to investigational treatment or comparator treatment
- •o Calculated CrCl <30 mL/minute (see Section 14.1)
- •o Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk
- •o Any severe condition that would limit life expectancy to less than 6 months (eg, advanced malignancy, etc.)
- •o Planned invasive procedure with potential for uncontrolled bleeding, including major surgery
- •o Inability to take oral medication
- •o Ongoing 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 a investigational drug or medical device within 30 days prior to randomization
- •-Previous randomization in this study
- •-Inability to complete the study procedures according to protocol
研究者
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