Anticoagulation Therapy in the Very Old (ATIVO)
ATIVO Study - Anticoagulation Therapy in the Very Old
研究概览
详细说明
This is a prospective registry study with data being collected continuously for 24 months.
Patients who have electrocardiographically confirmed atrial fibrillation, are being followed by the Pen Bay Medical Center Anticoagulation Services and are at least 90 years old will be recruited into the study. A matched cohort of patients between the ages of 80 and 89 and another matched cohort of patients between the ages of 70 and 79 will also be recruited into the study for comparison.
Data related to adverse events, concomitant medications, living arrangements, mobility and alcohol use will be collected every 6 months. In addition the CHA2DS2-VASc (score for atrial fibrillation stroke risk), HAS - BLED (major bleeding risk score for patients on anticoagulation), frailty and Mini Cog scores will be recalculated at each visit.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Maine
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Rockport、Maine、美国、04856
- Penobscot Bay Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- 70 years of age or older
- electrocardiographically confirmed atrial fibrillation
- anticipated regular follow up with patient by Penobscot Bay Medical Center (PBMC) Anticoagulation Services
- Subject or legally authorized representative must be willing to provide informed consent
Exclusion Criteria:
- Patients not being followed by the PBMC Anticoagulation Services
学习计划
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Aged 90 and older
Subjects 90 years and older with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
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Patients on warfarin for atrial fibrillation
其他名称：
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Aged 80-89
Subjects aged 80-89 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
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Patients on warfarin for atrial fibrillation
其他名称：
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Aged 70-79
Subjects aged 70-79 with atrial fibrillation, taking warfarin, followed by the Penobscot Bay Medical Center Anticoagulation Services.
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Patients on warfarin for atrial fibrillation
其他名称：
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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 Experiencing Stroke
大体时间：24 months
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Every 6 months the medical record was reviewed for evidence of stroke of any cause.
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24 months
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Number of Patients Experiencing a Major Bleeding Event
大体时间：24 months
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defined as one of the following: fatal bleeding, symptomatic bleeding in a critical area or organ or bleeding causing a fall in hemoglobin of 2 g/dl or more or leading to a transfusion of 2 or more units of whole blood or red cells
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24 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Patients Experiencing a Traumatic Subdural Hemorrhage
大体时间：24 months
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Number of subjects who experienced a traumatic subdural hemorrhage in each age group
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24 months
|
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Number of Patients Experiencing a Traumatic Intracerebral Hemorrhage
大体时间：24 months
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Number of subjects who experienced a traumatic intracerebral hemorrhage in each age group
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24 months
|
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Number of Hospitalizations Patients Experienced
大体时间：24 months
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Every 6 months the medical record was reviewed for any hospitalizations experienced by the subject within our healthcare system.
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24 months
|
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Number of Patients Experiencing Cardiovascular Death
大体时间：24 months
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Every 6 months the medical record was reviewed.
All deaths were researched for cause and noted if the cause was related to the cardiovascular system.
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24 months
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Number of Patients Experiencing Death Related to Anticoagulation
大体时间：24 months
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All deaths were reviewed in the medical record to determine the cause and if it was related in any way to the use of anticoagulation therapy.
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24 months
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Mean Time in Therapeutic Range at End of Study Participation
大体时间：up to 24 months
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International Normalized Ratio (INR) time in therapeutic range at the end of the individual's study participation.
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up to 24 months
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合作者和调查者
赞助
调查人员
- 首席研究员：Robert W. Stein, MD、MaineHealth
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.