TCTR20181104002已完成未知
Comparative anti-Factor Xa activity between standard dose and Japanese dose of rivaroxaban in Thai patients with non-valvular atrial fibrillation
Faculty of Medicine, Chiang Mai University0 个研究点目标入组 60 人开始时间: 2018年11月4日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 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
- Observational
入排标准
- 年龄范围
- 18 Years 至 0 N/A (No limit)（—）
- 性别
- All
入选标准
- •1. Men or women Aged ≥ 18 years
- •2. Patients with non-valvular AF who have been receiving rivaroxaban
- •3. Atrial fibrillation must be documented by ECG evidence (e.g., 12-lead ECG, rhythm strip, Holter, pacemaker interrogation) within 30 days before enrolled. In addition, subjects must have medical evidence of atrial fibrillation within 1 year before and at least one day before the qualifying ECG evidence. This could be obtained from a notation in the subject's record (e.g., medical chart, hospital discharge summary).
- •4. Female subjects must be postmenopausal (for at least 2 years), surgically sterile, abstinent, or, if sexually active, be practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, have a negative serum β-hCG pregnancy test at screening.
- •5. Subjects must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
排除标准
- •1. Patients with severe renal impairment (CrCl<15 mL/min)
- •2. Cardiac-Related Conditions: Hemodynamically significant mitral valve stenosis, prosthetic heart valve (annuloplasty with or without prosthetic ring, commissurotomy and/or valvuloplasty are permitted), planned cardioversion (electrical or pharmacological), transient atrial fibrillation caused by a reversible disorder (e.g., thyrotoxicosis, PE, recent surgery, MI), known presence of atrial myxoma or left ventricular thrombus, active endocarditis
- •3. Hemorrhage Risk-Related Criteria:
- •â€¢ Active internal bleeding
- •â€¢ History of or condition associated with increased bleeding risk
- •including, but not limited to:
- •â€ Major surgical procedure or trauma within 30 days before
- •the randomization visit
- •â€ Clinically significant gastrointestinal bleeding within 6
- •months before the randomization visit
- •â€ History of intracranial, intraocular, spinal, or
- •atraumatic intra-articular bleeding
- •â€ Chronic hemorrhagic disorder
- •â€ Known intracranial neoplasm, arteriovenous malformation,
- •or aneurysm
- •â€¢ Planned invasive procedure with potential for uncontrolled
- •bleeding, including major surgery
- •â€¢ Platelet count <90,000/μL at the screening visit
- •â€¢ Sustained uncontrolled hypertension: systolic blood pressure
- •â‰¥180 mmHg or diastolic blood pressure ≥100 mmHg
- •4. Anemia (hemoglobin <10 g/dL) at the screening visit
- •5. Pregnancy or breast-feeding
- •6. Patients with poor compliance to medication
- •7. Patients who refuse to obtain informed consent
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