Non-Interventional Study Describing Direct Costs Related to Anti-coagulation Treatment
2022年5月5日 更新者：Pfizer
Non-interventional Study Describing Direct Costs Related to Anticoagulation Treatment in Patients With Nonvalvular Atrial Fibrillation (NVAF) in Secondary Stroke Prevention Prescribed Apixaban or Warfarin Treatment
To describe the direct costs related to warfarin/apixaban treatment
研究概览
地位
完全的
条件
详细说明
To describe the direct costs related to warfarin/apixaban treatment during the first 6 months of the secondary stroke prevention in NVAF patients.
研究类型
观察性的
注册 (实际的)
109
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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Praha 5、捷克语、150 06
- Fakultni nemocnice Motol
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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、OLDER_ADULT)
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
NVAF patients, who used either warfarin or apixaban as a secondary stroke/TIA prevention.
描述
Inclusion Criteria:
- Diagnosis of non-valvular atrial fibrillation (NVAF);
- New initiation of anticoagulation therapy (apixaban or warfarin) due to the ischemic event (stroke/TIA) meaning patients previously not anticoagulated due to diagnosis of NVAF;
- Indication to anticoagulation therapy as a secondary stroke prevention within 7 to 30 days after the stroke/TIA event;
- Apixaban arm: genetically determined higher sensitivity to warfarin;
- Patients whose status allowed oral treatment with apixaban/warfarin;
- Age ≥ 18;
- Access to patient´s records of the first 6 months of the warfarin/apixaban treatment.
Exclusion Criteria:
- Diagnosis of valvular disease;
- Treatment with other anticoagulants in previous 6 months due to other the NVAF indication;
- Treatment or prophylaxis of deep vein thrombosis or pulmonary embolism;
- Contraindications according SmPC of Eliquis
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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Non-valvular Atrial Fibrillation (NVAF) on warfarin
The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used warfarin as a secondary stroke/TIA prevention.
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Non-valvular Atrial Fibrillation (NVAF) on apixaban
The study follows two cohorts of Non-valvular Atrial Fibrillation (NVAF) patients, who used apixaban as a secondary stroke/TIA prevention.
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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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基线时的 CHA2-DS2-VASc 评分
大体时间：基线（来自研究中检索到的回顾性数据）
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CHA2DS2-VASc 评分量表用于评估 NVAF 参与者中风和全身性栓塞的风险。
CHA2DS2-VASc 评分是根据 8 个风险因素（年龄 65-74 岁、年龄 >=75 岁、性别类别，即女性、充血性心力衰竭病史、高血压病史、中风/TIA/血栓栓塞病史、血管疾病病史和糖尿病史）。
CHA2DS2-VASc 总分范围为 0-9，其中 0 = 低风险，9 = 中风高风险。
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基线（来自研究中检索到的回顾性数据）
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HAS-BLED Score at Baseline
大体时间：Baseline (from retrospective data retrieved in the study)
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HAS-BLED scoring scale was used to estimate the risk of bleeding.
HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use).
Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
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Baseline (from retrospective data retrieved in the study)
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CHA2-DS2-VASc Score at Month 6
大体时间：Month 6 (from retrospective data retrieved in the study)
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CHA2DS2-VASc scoring scale was used to estimate the risk of stroke and systemic emboli in participants with NVAF.
CHA2DS2-VASc score was calculated based on 8 risk factors (age 65-74 years, age >=75 years, sex category i.e. female sex, congestive heart failure history, hypertension history, stroke/TIA/thromboembolism history, vascular disease history and diabetes mellitus history).
Total CHA2DS2-VASc score ranged from 0-9 where 0= low risk and 9= high risk of stroke.
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Month 6 (from retrospective data retrieved in the study)
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HAS-BLED Score at Month 6
大体时间：Month 6 (from retrospective data retrieved in the study)
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HAS-BLED scoring scale was used to estimate the risk of bleeding.
HAS-BLED score was calculated based on 9 risk factors (hypertension, renal disease, liver disease, stroke history, prior major bleeding or predisposition to bleeding, labile international normalized ratio (INR), age >65 years, medication usage predisposing to bleeding and alcohol use).
Total HAS-BLED score ranged from 0 to 9 where 0 = low risk and >=3 = high risk of bleed.
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Month 6 (from retrospective data retrieved in the study)
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Percentage of Participants Categorized According to Number of Outpatient Visits During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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In this outcome measure, percentage of participants were categorized according to number of outpatient visits from 0 to 5.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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治疗前 6 个月的门诊费用
大体时间：最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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治疗前 6 个月的门诊就诊费用计算为就诊次数乘以就诊费用 (450.0
每次访问捷克克朗 [CZK]）。
费用根据治疗期间的门诊就诊次数计算。
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最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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Percentage of Participants Categorized According to Number of International Normalized Ratios (INR) Measurements During First 6 Months of Treatment
大体时间：最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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INR 定义为参与者的凝血酶原时间与正常平均凝血酶原时间的比值。
凝血酶原时间定义为接受口服抗凝药物的参与者血液凝结所需的时间。
在此结果测量中，参与者的百分比根据 INR 测量的数量进行分类，包括零 (0)、1 至 9、10 至 19 和大于或等于 (>=) 20。
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最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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Cost of INR Measurements During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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INR was defined as the ratio of the participant's prothrombin time and the normal mean prothrombin time.
Prothrombin time defined as a time taken by the blood to clot in participants receiving oral anticoagulant medication.
Costs related to INR measurements, were calculated for the period of 6 months as the number of INR measurements multiplied by the cost of the INR measurement (213.0
CZK per measurement).
Costs were based on the expenditure of total number of INR measurements during first 6-month treatment.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Dosage of Warfarin and Apixaban at the Initiation of the Treatment
大体时间：基线（来自研究中检索到的回顾性数据）
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在此结果测量中，报告了治疗开始时使用的阿哌沙班和华法林的剂量。
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基线（来自研究中检索到的回顾性数据）
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Dosage of Warfarin and Apixaban During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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In this outcome measure, dosage of apixaban and warfarin used during first 6 months of treatment was reported.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Cost of Medication During First 6 Months of Treatment
大体时间：最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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在这个结果测量中，药物成本，即阿哌沙班和华法林的成本是基于活性物质的剂量，并计算治疗的前 6 个月（每日成本乘以 182.4 天），无论个体参与者治疗多长时间已经报道。
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最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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Percentage of Participants Categorized According to Number of Hospital Admissions
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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In this outcome measure, percentage of participants were categorized according to number of hospital admissions from 0 to 3 were reported.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Cost of Hospital Admissions During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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In this outcome measure, costs of hospital admissions were based on the number of hospital admissions during the treatment period by considering the reason for hospitalization.
If the reason for admission was not related to the recorded event (ischemic, hemorrhagic, or other adverse event), or the participant experienced none of these events, the cost of hospitalization was calculated as the number of days multiplied by the cost per a day of hospitalization (1898.2
CZK per day).
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Percentage of Participants Categorized According to Number of Diagnostic Procedures
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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In this outcome measure, percentage of participants were categorized according to number of diagnostic procedures.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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在治疗的前 6 个月内根据缺血事件类型分类的参与者百分比
大体时间：最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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在此结果测量中，参与者的百分比根据包括心脏缺血和中风/TIA 在内的缺血事件类型进行分类。
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最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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Cost of Ischemic Events During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Costs of ischemic events (cardiac ischemia and stroke/TIA) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of ischemic events during the first 6 months of treatment.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Percentage of Participants Categorized With Major Hemorrhagic Events During First 6 Months of Treatment
大体时间：最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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在此结果测量中，报告了包括颅内出血在内的主要出血事件的参与者百分比。
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最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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Percentage of Participants Categorized According to Type of Minor Hemorrhagic Events During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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In this outcome measure, percentage of participants were categorized according to type of minor hemorrhagic events which included epistaxis, gastrointestinal (GI) bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Cost of Major Hemorrhagic Events During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Costs of major hemorrhagic events (intracranial bleeding) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of major hemorrhagic events during the first 6 months of treatment.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Cost of Minor Hemorrhagic Events During First 6 Months of Treatment
大体时间：最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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Costs of minor hemorrhagic events (epistaxis, GI bleeding, muscle hematomas and intraparenchymal hematoma of the lower lobe) included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the recorded number of minor hemorrhagic events during the first 6 months of treatment.
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最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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Number of Participants With Other Adverse Events During First 6 Months of Treatment
大体时间：最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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不良事件 (AE) 是在接受研究药物的参与者中发生的任何不良医学事件，而不考虑因果关系的可能性。
其他不良事件包括除缺血性、主要和次要出血事件之外的所有事件。
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最多前 6 个月的治疗（来自研究中检索到的回顾性数据）
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Cost of Other Adverse Events During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Costs of other adverse events included expenditure of diagnosis, medication, outpatient visits and hospitalization were reported based on the number of other adverse events during the treatment.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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Percentage of Participants Who Died (Treatment-Related) During First 6 Months of Treatment
大体时间：Up to first 6 months of treatment (from retrospective data retrieved in the study)
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In this outcome measure, percentage of participants who died due to the given treatment were reported.
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Up to first 6 months of treatment (from retrospective data retrieved in the study)
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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。
赞助
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。
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)
2020年8月4日
初级完成 (实际的)
2021年5月31日
研究完成 (实际的)
2021年5月31日
研究注册日期
首次提交
2020年6月15日
首先提交符合 QC 标准的
2020年6月15日
首次发布 (实际的)
2020年6月17日
研究记录更新
最后更新发布 (实际的)
2023年2月8日
上次提交的符合 QC 标准的更新
2022年5月5日
最后验证
2022年5月1日
更多信息
与本研究相关的术语
其他研究编号
- B0661121
- APIXABAN SECOND LINE (其他：Alias Study Number)
计划个人参与者数据 (IPD)
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IPD 计划说明
辉瑞将提供对个人去识别参与者数据和相关研究文件（例如
协议、统计分析计划 (SAP)、临床研究报告 (CSR)）根据合格研究人员的要求，并遵守某些标准、条件和例外情况。
有关辉瑞数据共享标准和请求访问流程的更多详细信息，请访问：https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests。
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