NCT02147444Unknown不适用
Multi-center, Prospective, Non-interventional, Observational Cohort Study to Investigate Effectiveness and Safety of Rivaroxaban on Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation in Japanese Clinical Practice
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 7,000
- 试验地点
- 1
- 主要终点
- Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
研究概览
简要总结
The efficacy and safety of a novel oral Xa inhibitor for stroke and systemic embolism, namely rivaroxaban, in non-valvular atrial fibrillation patients are evaluated in Japanese clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who meet all the criteria below
- •Patients aged over 20 years
- •Patients diagnosed with non-valvular atrial fibrillation
- •Patients who are treated or will be treated with rivaroxaban
- •Patients from whom written informed consent has been obtained
排除标准
- •Patients who meet any of the criteria below
- •The following patients in whom rivaroxaban is contraindicated for use
- •Patients with a history of allergies to the ingredients contained in this drug
- •Patients having a hemorrhagic event (intracranial hemorrhage, gastrointestinal hemorrhage or other clinically significant hemorrhagic events)
- •Patients having liver disease complicated with coagulation disorder or those having moderate or worse liver disorder (Grade B or C in accordance with the Child-Pugh classification)
- •Patients having renal failure (creatinine clearance: <15 mL/min)
- •Women who are or are likely to be pregnant
- •Patients who are treated with HIV protease inhibitors (including ritonavir, atazanavir and indinavir)
- •Patients who are treated with oral or injectable formulations of azole antifungal drugs (including itraconazole, voriconazole and ketoconazole (excluding fluconazole))
结局指标
主要结局
Combinations of symptomatic stroke (ischemic or hemorrhagic) and systemic embolism
时间窗: up to March/2016
Primary efficacy endpoint
Clinically significant hemorrhagic events (massive hemorrhage in accordance with the ISTH classification)
时间窗: up to March/2016
Primary safety endpoint
次要结局
- Combinations of symptomatic stroke (ischemic or hemorrhagic), systemic embolism, myocardial infarction and cardiovascular death(up to March/2016)
- Symptomatic ischemic stroke(up to March/2016)
- Symptomatic hemorrhagic stroke(up to March/2016)
- Systemic embolism(up to March/2016)
- Acute myocardial infarction/unstable angina pectoris(up to March/2016)
- Cardiovascular death(up to March/2016)
- Deep vein thrombosis/pulmonary thromboembolism(up to March/2016)
- Transient ischemic attack(up to March/2016)
- Interventional/surgical treatment(up to March/2016)
- All-cause death(up to March/2016)
- Clinically insignificant hemorrhagic events (hemorrhagic events other than clinically significant hemorrhagic events)(up to March/2016)
研究者
Hiroaki Shimokawa, MD, PhD
MD, PhD, Department of Cardiovascular Medicine
Tohoku University
研究点 (1)
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