EUCTR2012-001062-15-BG进行中（未招募）不适用
An open-label, international, multicenter, interventional study exploring the efficacy of once-daily oral rivaroxaban (BAY 59-7939) for the treatment of left atrial/left atrial appendage thrombus in subjects with nonvalvular atrial fibrillation or atrial flutter - X-TRA
适应症
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
- 60
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 AF or atrial flutter
- •- LA/LAA thrombus documented at baseline by transesopheagel echocardiography (TEE) up to 72 hours prior to start of study medication
- •- vitamin K antagonist(s) (VKA)/ new oral anticoagulant(s) (NOAC)-naïve or untreated within 1 month prior to signing of the informed consent form or VKA pretreated but under ineffective INR levels (< 2.0, documented with at least 2 consecutive measurements that are at least 24 hours apart) within last 6 weeks
- •- Women of childbearing potential and men must agree to use adequate contraception when sexually active
- •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 7
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Transient Ischemic Attack within 3 days prior to study inclusion
- •- Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months or any stroke within 14 days before the start of study drug
- •- Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to study inclusion
- •- Acute myocardial infarction within the last 14 days prior to study inclusion
- •- Cardiac-related criteria: Previous intracardiac thrombus, Free-floating ball thrombus, Intracardiac tumor, known left ventricular or aortic thrombus, active endocarditis
- •- Active bleeding or high risk for bleeding contraindicating anticoagulant therapy
- •- Concomitant drugs/therapies: Indication for anticoagulant therapy for a condition other than nonvalvular AF or atrial flutter (eg, VTE). Concomitant use of anticoagulant drugs, including VKA, or factor IIa or factor Xa inhibitors. Chronic aspirin therapy >100 mg or dual antiplatelet therapy. Concomitant 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 antimycotics agents—ketoconazole, itraconazole, voriconazole, and posaconazole—if used systemically
- •- Concomitant conditions: Childbearing potential without proper contraceptive measures, pregnancy, or breast feeding. Hypersensitivity to investigational treatment. Calculated creatinine clearance [CrCl] < 15 mL/minute at the screening visit. Hepatic disease which is associated with coagulopathy leading to a clinically relevant bleeding risk. Any severe condition that would limit life expectancy to less than 3 months (eg, advanced malignancy, etc.). Planned invasive procedure with potential for uncontrolled bleeding or increased risk of stroke, including major surgery, cardiac catheterization, or cardioversion prior to the end-of-treatment TEE. Inability to take oral medication. Ongoing drug addiction or alcohol abuse
研究者
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