Anticoagulant Utilization Pattern
2019年3月26日 更新者:Boehringer Ingelheim
A Description of Warfarin and NOAC Utilization Patterns Including Initiation, Switching, and Discontinuation
This study plans to describe utilization patterns for oral anticoagulants over time in patients with non-valvular atrial fibrillation at risk for stroke using electronic claims data from a United States commercial insurance 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)
333664
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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Massachusetts
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Boston、Massachusetts、美国、02120
- Brigham and Women's Hospital
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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
Patients 18 years of age and older with non-valvular AF at risk for stroke treated with oral anticoagulation
描述
Inclusion criteria:
- A recorded diagnosis of atrial fibrillation
- Initiation of oral anticoagulant medication
- Congestive Heart Failure, Hypertension, Age > 75, Diabetes Mellitus, Prior Stroke or Transient Ischemic Attack, Vascular Disease, Age 65-74, Sex Category (CHA2DS2-VASc) Score >=1
- At least 18 years of age on the date of anticoagulant initiation
Exclusion criteria:
- Patients with missing or ambiguous age or sex information
- Patients with documented evidence of valvular disease
- Patients with less than 12 months enrolment in the UnitedHealth Research Database preceding the first dispensing
- Patients with prior use of any oral anticoagulant
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
队列和干预
团体/队列 |
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达比加群酯
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Warfarin or other New Oral Anticoagulant (NOAC)
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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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Description of the Characteristics of Anticoagulant Initiators
大体时间:From January 2009 to September 2015 (The study period)
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The analyses described the characteristics of patients treated with various oral anticoagulants.
CHA2DS2-VASc stroke risk score is calculated based on the following conditions: Congestive heart failure/ Left ventricular (LV) dysfunction, Hypertension, Age (≥ 75), Diabetes Mellitus, Stroke/ transient ischemic attack (TIA) /thromboembolism, Vascular disease, Age 65-74, female gender.
HAS-BLED bleeding risk score is calculated based on the following conditions: Hypertension, Abnormal renal and liver function, Stroke (1 point), Bleeding history or predisposition, Labile international normalized ratio (INR), Elderly (>65 years), Drugs and Alcohol.
CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
HAS-BLED bleeding risk score may range from 0 to 9 with 0 being the best outcome.
New initiators of warfarin before Dabigatran became available were only characterized in terms of age and sex (results provided above).
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant
大体时间:From January 2009 to September 2015 (The study period)
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Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
This is related to UnitedHealth database and no treatment initiation rate was estimated in MarketScan as the study cohort was defined from a population of oral anticoagulants users.
The overall number of participants analyzed "609201" reported for each of the treatment arm below corresponds to overall patients numbers in UnitedHealth for the entire study period rather than for each of the treatment arm.
Likewise the number of participants for each of the treatment arm for different time period corresponds to the total number of participants for the specific study period rather than for each of the treatment arm.
Incident users at given time period could also be counted in later time period if the patient discontinued the drug and had re-entry during the study period.
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant Dose - Dabigatran
大体时间:From January 2009 to September 2015 (The study period)
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Percentage of patients initiating specific anticoagulant dose of dabigatran across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant Dose - Apixaban
大体时间:From January 2009 to September 2015 (The study period)
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Percentage of patients initiating specific anticoagulant dose of apixaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
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Percentage of Patients Initiating Specific Anticoagulant Dose - Rivaroxaban
大体时间:From January 2009 to September 2015 (The study period)
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Percentage of patients initiating specific anticoagulant dose of rivaroxaban across all time periods combined in the unmatched cohort for UnitedHealth and MarketScan cohort are presented.
Proportion of patients initiating specific anticoagulant over time per arm in source cohort is estimated and is expressed in percentage.
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From January 2009 to September 2015 (The study period)
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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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Treatment Persistence Over Time
大体时间:From January 2009 to September 2015 (The study period)
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Overall treatment persistence in UnitedHealth and MarketScan cohorts are presented as the percentage of patients who were persistent to treatment after 3, 6 and 12 months of follow-up for all time periods combined and matched cohort.
Based on two US-based longitudinal healthcare claims databases (MarketScan and unitedHealth Research Database) the three separate study cohorts warfarin vs dabigatran, warfarin vs rivaroxaban and warfarin vs apixaban cohort were formed for each database.
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From January 2009 to September 2015 (The study period)
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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)
2013年4月17日
初级完成 (实际的)
2017年11月1日
研究完成 (实际的)
2017年11月1日
研究注册日期
首次提交
2013年4月18日
首先提交符合 QC 标准的
2013年5月2日
首次发布 (估计)
2013年5月7日
研究记录更新
最后更新发布 (实际的)
2019年6月27日
上次提交的符合 QC 标准的更新
2019年3月26日
最后验证
2019年3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.