Patient Convenience Study (RE-SONANCE)
2019年5月22日 更新者：Boehringer Ingelheim
Non-interventional Study Describing Patients´ Perception on Anticoagulant Treatment and Treatment Convenience When Treated With Pradaxa or Vitamine K Antagonist for Stroke Prevention in Non-Valvular Atrial Fibrillation
The aim of this non-interventional study is to describe patient's perception of anticoagulant treatment when using Pradaxa to prevent stroke and systemic embolism while suffering from atrial fibrillation (according to its approved indication in the approved dosages of 110 milligrams or 150 milligrams twice daily) in comparison to standard care using Vitamin K Antagonist (VKA).
研究概览
研究类型
观察性的
注册 (实际的)
9472
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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Multiple Locations、以色列
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Multiple Locations、俄罗斯联邦
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Multiple Locations、保加利亚
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Multiple Locations、匈牙利
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Multiple Locations、塞尔维亚
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Multiple Locations、奥地利
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Multiple Locations、拉脱维亚
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Multiple Locations、捷克语
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Multiple Locations、斯洛文尼亚
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Multiple Locations、波兰
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Multiple Locations、爱沙尼亚
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Multiple Locations、罗马尼亚
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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
European patients with non valvular atrial fibrillation
描述
Inclusion criteria:
Cohort A:
- A. Written informed consent prior to participation
- A. Female and male patients >= 18 years of age with a diagnosis of non-valvular atrial fibrillation.
- A. At least 3 months of continuous VKA treatment for stroke prevention prior to baseline assessment.
- A. Patients switched to Pradaxa according Summary of Product Characteristics and physician's discretion.
OR
Cohort B:
- B. Written informed consent prior to participation.
- B. Female and male patients >= 18 years of age newly diagnosed with non-valvular atrial fibrillation and no previous treatment for stroke prevention (no use of any oral anticoagulant (OAC) within one year prior to enrolment).
- B. Stroke prevention treatment initiated with Pradaxa or VKA according to Summary of Product Characteristics and physician's discretion.
Exclusion criteria:
- Contraindication to the use of Pradaxa or VKA as described in the Summary of Product Characteristics (SmPC).
- Patients receiving Pradaxa or VKA for any other condition than stroke prevention in atrial fibrillation.
- Current participation in any clinical trial of a drug or device.
- Current participation in an European registry on the use of oral anticoagulation in AF.
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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Cohort A - VKA to Pradaxa switcher
Patients with non-valvular atrial fibrillation (NVAF), currently on Vitamin K Antagonist (VKA) therapy, who are switched to Pradaxa.
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Cohort B - newly assigned to treatment
Newly diagnosed NVAF patients who are treated with VKA or Pradaxa (VKA : Pradaxa = 1:1).
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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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Convenience PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
大体时间：From baseline up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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From baseline up to 210 days
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Satisfaction PACT-Q2 Scores at Second and Last Assessment Compared to Baseline Assessment
大体时间：From baseline up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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From baseline up to 210 days
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Convenience PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
大体时间：Day 30 up to Day 210
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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Day 30 up to Day 210
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Satisfaction PACT-Q2 Scores at Second and Last Assessment Between Treatment Groups
大体时间：Day 30 up to Day 210
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
The PACT-Q2 is to be administered to patients once treatment is ongoing.
Due to the non-normality of the data, results presented are for median change instead of mean change in PACT-Q2 scores from baseline (V1) to Initiation stage (V2) and from baseline (V1) to Continuation stage (V3) with full range instead of standard deviation of the differences.
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Day 30 up to Day 210
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Characterization of Patients With Respect to Congestive Heart Failure, Hypertension, Age (≥75), Diabetes Mellitus, Stroke/Transient Ischemic Attack (TIA), Vascular Disease, Age 65-75, Sex Category (CHA2DS2-VASc) Score
大体时间：Baseline
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CHA2DS2-VASc score, are clinical prediction rules for estimating the risk of stroke in patients with non-rheumatic atrial fibrillation (AF), a common and serious heart arrhythmia associated with thromboembolic stroke.
Such a score is used to determine whether or not treatment is required with anticoagulation therapy or antiplatelet therapy.
CHA2DS2-VASc stroke risk score may range from 0 to 9 with 0 being the best outcome.
Score of < 2 was considered as low or intermediate risk and score of ≥ 2 was considered as high risk.
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Baseline
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Characterization of Patients With Respect to Hypertension, Abnormal Renal and Liver Function, Stroke, Bleeding History or Predisposition, Labile International Normalized Ratio (INR), Elderly (>65 Years), Drug and Alcohol (HAS-BLED) Score
大体时间：Baseline
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HAS-BLED is a scoring system developed to assess 1-year risk of major bleeding in patients with atrial fibrillation.
A calculated HAS-BLED score is between 0 and 9 and based on eight parameters with a weighted value of 0-2.
A high score corresponds to a greater risk, while low score corresponds to a lower risk.
Data presented are percentage of patients with high and low risk.
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Baseline
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Characterization of Patients With Respect to Kidney Function (Creatinine Clearance)
大体时间：Baseline and up to 210 days
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Creatinine is a waste product produced by muscles from the breakdown of a compound called creatine.
Creatinine is filtered from the blood by the kidneys and released into the urine.
A creatinine clearance test measures creatinine levels in both a sample of blood and a sample of urine from a 24-hour urine collection.
The results are used to calculate the amount of creatinine that has been cleared from the blood and passed into the urine.
Data presented here are geometric mean and confidence interval of creatinine clearance for patients at baseline (V1), initiation stage (V2) and continuation stage (V3).
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Baseline and up to 210 days
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Characterization of Patients With Respect to Comorbidities
大体时间：Baseline
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Comorbidity is the presence of one or more additional diseases or disorders co-occurring with (that is, concomitant or concurrent with) a primary disease or disorder.
Data presented here are percentage of total patients with comorbidities.
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Baseline
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Characterization of Patients With Respect to Concomitant Therapies
大体时间：Baseline
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Concomitant therapies are two or more drugs used or given at or almost at the same time.
The data presented here are percentage of total patients for taking concomitant medication.
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Baseline
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Characterization of Patients With Respect to Dosing of Pradaxa
大体时间：Baseline and up to 210 days
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The data presented in this outcome measure is percentage of patients in both cohorts receiving 110 mg and 150 mg dose of Pradaxa at baseline (V1).
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Baseline and up to 210 days
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Duration in Months of Previous VKA Treatment
大体时间：Baseline
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The data presented in this outcome measure are Mean (SD) of duration in months of previous VKA treatment in total patients in cohort A.
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Baseline
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Stroke- and/or Bleeding Related Risk Factors in Medical History and at Baseline (Not Applicable)
大体时间：Baseline
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This endpoint is not assessable as the necessary data was not collected in the database
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Baseline
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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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PACT-Q2 Scores at Last Assessment Compared to Second Assessment
大体时间：From 30 days up to 210 days
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The individual questions in PACT-Q2 were grouped into two domains, convenience and satisfaction.
For each domain, a global score was calculated and used for analysis.
The range of the global score is 0-100, with higher score indicating better outcome.
The global score is calculated by summing up the individual scores, and then rescaled to 0-100.
Due to the non-normality of the data, results presented here are median change in PACT-Q2 scores between initiation stage (V2) and Continuation stage (V3).
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From 30 days up to 210 days
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Description of PACT-Q1 Items at Baseline
大体时间：Baseline
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Patients in Cohort B were given PACT-Q1 to assess patients' expectation from Anticoagulation therapy.
Following are the seven items from PACT-Q1.
The score range is 1-5.
Each question is analyzed individually, with higher score indicating better outcome.
A1 - How confident are you that your anticoagulant treatment (AT) will prevent blood clots?
A2 - Do you expect that your AT will relieve some of the symptoms you experience?
A3 - Do you expect that your AT will cause side effects such as minor bruises or bleeding?
A4 - How important is it for you to have an AT that is easy to take?
A5 - How concerned are you about making mistakes when taking your AT? A6 - How important is it for you to take care of your AT by yourself?
A7 - How concerned are you about how much you may have to pay for your AT?
For questions A1, A2, A4 and A6, higher score is higher expectations of the treatment and for questions A3, A5 and A7, lower score is higher expectations of the treatment.
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Baseline
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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)
2015年11月11日
初级完成 (实际的)
2017年6月1日
研究完成 (实际的)
2017年6月1日
研究注册日期
首次提交
2015年11月11日
首先提交符合 QC 标准的
2016年2月17日
首次发布 (估计)
2016年2月18日
研究记录更新
最后更新发布 (实际的)
2019年7月24日
上次提交的符合 QC 标准的更新
2019年5月22日
最后验证
2019年5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.