Treatment Pattern of Oral Anticoagulants (OAC) in Japan
2018年9月7日 更新者：Boehringer Ingelheim
Treatment Patterns of Newly Initiated Oral Anticoagulants on Japanese Non-valvular Atrial Fibrillation Patients Using a Japanese Claims Database
- To understand the treatment patterns of OACs and baseline patient characteristics of Japanese Non-Valvular Atrial Fibrillation (NVAF) patients
- To determine whether warfarin and dabigatran new user group can be balanced using propensity score matching using pre-specified baseline covariates.
- As an exploratory analysis, to assess mean duration of on-therapy follow-up time in database
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
48696
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Tokyo, Shinagawa、日本、1416017
- NISED Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Medical Data Vision (MDV) clinical database
描述
Inclusion criteria:
- Patients aged >18 year-old with confirmed diagnosis of NVAF (ICD 10 code I48), being new starters of either dabigatran, warfarin, apixaban or edoxaban, having no prescription of other OACs for12 months prior to the index date (defined as the first prescription of OACs (the period is defined as baseline period)), and having an index date between 14 Mar 2011 to 30 June 2016
Exclusion criteria:
- Patients having less than 12 months of enrolment prior to the index date , being dialysis or kidney transplant recipients in baseline period, having either atrial flutter, valvular AF, mechanical valve placement, rheumatic AF, and/or mitral valve prolapse/regurge/stenosis in baseline period, and having record of deep vein thrombosis or pulmonary embolism < 6 months before Atrial Fibrillation (AF) diagnosis in baseline period
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：追溯
队列和干预
团体/队列 |
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All Patients
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Patients by Each Type of Study-target OAC Drug Prescribed for New Users of Anticoagulants With NVAF
大体时间：Day 1
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Number of patients by each type of study-target OAC drug (dabigatran, warfarin, apixaban, rivaroxaban, or edoxaban) prescribed as the first Oral Anticoagulants (OAC) with Non-valvular atrial fibrillation (NVAF)
|
Day 1
|
|
Number of Patients Prescribed OAC Drug Dabigatran by Dosage
大体时间：Day 1
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Number of patients prescribed OAC drug dabigatran at the index date by dosage.
If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
|
Day 1
|
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Number of Patients Prescribed OAC Drug Warfarin by Dosage
大体时间：Day 1
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Number of patients prescribed OAC drug Warfarin at the index date by dosage.
If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
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Day 1
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Number of Patients Prescribed OAC Drug Rivaroxaban by Dosage
大体时间：Day 1
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Number of patients prescribed OAC drug rivaroxaban at the index date by dosage.
If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
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Day 1
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Number of Patients Prescribed OAC Drug Apixaban by Dosage
大体时间：Day 1
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Number of patients prescribed OAC drug Apixaban at the index date by dosage.
If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
|
Day 1
|
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Number of Patients Prescribed OAC Drug Edoxaban by Dosage
大体时间：Day 1
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Number of patients prescribed OAC drug edoxaban at the index date by dosage.
If a patient had more than one prescriptions of an OAC at the day, the patient was multiple-counted.
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Day 1
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Baseline Characteristics: Age
大体时间：1 day
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Baseline characteristics of patients in each treatment group: age
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1 day
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Baseline Characteristics: Gender
大体时间：Day 1
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Baseline characteristics of patients in each treatment group: gender
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Day 1
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Baseline Characteristics: Year of Initiating Treatment
大体时间：Day 1
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Baseline characteristics of patients in each treatment group: year of initiating treatment
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Day 1
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Baseline Characteristics: Speciality of Prescribers of OAC
大体时间：Day 1
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Baseline characteristics of patients in each treatment group: speciality of prescribers of OAC. int.= internal; Med.= Medicine |
Day 1
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Baseline Characteristics: History of Disease
大体时间：Day 1
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Baseline characteristics of patients in each treatment group: history of disease and hospitalization.
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Day 1
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Baseline Characteristics: History of Hospitalization
大体时间：Day 1
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Baseline characteristics: history of hospitalization
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Day 1
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Baseline Characteristics: AF Risk Score
大体时间：Day 1
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Baseline characteristics of patients in each treatment group: Atrial Fibrillation (AF) risk score CHADS2: Congestive heart failure, Hypertension, Age, Diabetes, Stroke(doubled). CHADS2 score range from 0-6, with higher scores indicating the higher risk CHA2DS2VASc: Cardiac failure or dysfunction, Hypertension, Age 75 (doubled), Diabetes, Stroke (doubled) Vascular disease, Age 65-74 and Sex category (female) score. CHA2DS2VASc score range from 1-9, with higher scores indicating the higher risk. HAS-BLED: Hypertension, Abnormal renal function, Abnormal hepatic function. HAS-BLED score range from 0-8, with higher scores indicating the higher risk. |
Day 1
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Baseline Characteristics: Concomitant Medication
大体时间：Day 1
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Baseline characteristics of patients in each treatment group: concomitant medication |
Day 1
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
有用的网址
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年12月1日
初级完成 (实际的)
2016年12月1日
研究完成 (实际的)
2016年12月1日
研究注册日期
首次提交
2016年11月29日
首先提交符合 QC 标准的
2016年12月1日
首次发布 (估计)
2016年12月6日
研究记录更新
最后更新发布 (实际的)
2018年9月14日
上次提交的符合 QC 标准的更新
2018年9月7日
最后验证
2018年9月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.