I.M. Sechenov First Moscow State Medical University (Sechenov University)
2022年3月31日 更新者：I.M. Sechenov First Moscow State Medical University
Optimization of Anticoagulant Therapy in Outpatient Practice
Single-institution uncontrolled open-label trial.
研究概览
详细说明
The single-institution uncontrolled open-label trial is to optimize the anticoagulant therapy in the out-patient practice.
The study embraces patients who are advised to take the anticoagulant therapy for some reasons. The study has two phases - a retrospective part and a concurrent part. At the first phase, researchers analyze the compliance with the anticoagulant therapy in the real clinical practice. At the concurrent phase, researchers conduct a single-institution uncontrolled open-label trial to evaluate the effectiveness, safety of the anticoagulant therapy and compliance with it at the antithrombotic therapy control ward, and estimate the glomerular filtration rate in patients taking the anticoagulant therapy.
研究类型
介入性
注册 (实际的)
1000
阶段
- 不适用
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 至 120年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- the age above 18
- indications for the anticoagulant therapy
- informed consent for inclusion into trials
Exclusion Criteria:
- denial to proceed in the trial
Non-inclusion criteria:
pregnancy and lactation
- Intracerebral hemorrhage within three preceding months
- severe mental disorders* which could possibly affect the anticoagulant therapy dosage schedule
- anemia and a decrease in Hb by ˂100 GM/DL*
- active gastroduodenal ulcer
- active bleeding during the preceding month
- other intensive bleeding instances as per the TIMI Score within three weeks before the inclusion
- severe hepatic impairment for over 10 points under the Child-Pugh Score
- oncology disease with the life expectancy less than one year
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
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：anticoagulants arm
The study embraces patients who are advised to take the anticoagulant therapy (as per the European Society of Cardiology Guidelines).
The study evaluates the compliance with the anticoagulant therapy, safety and effectiveness, mortality
|
Patients who need anticoagulants were consulted by a cardiologist with subsequent recommendations
|
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 |
|---|---|---|
|
kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function
大体时间：Evaluation of GFR, bleeding and thrombotic complications after 2 years
|
During a visit to the clinic, the patient will be surveyed and tested for the creatinine level
|
Evaluation of GFR, bleeding and thrombotic complications after 2 years
|
|
death due to any cause
大体时间：in six years after the anticoagulant therapy is prescribed
|
phone survey when patients are invited to the clinic
|
in six years after the anticoagulant therapy is prescribed
|
|
cardiovascular mortality
大体时间：Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years
|
Phone survey when patients are invited to the clinic.
The term cardiovascular mortality means a set of fatal heart attacks, fatal strokes, sudden death, fatal thromboembolism.
|
Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 2 years
|
|
kidney function trend
大体时间：Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years
|
phone survey when patients are invited to the clinic for testing the creatinine level and further estimation of the glomerular filtration rate
|
Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 3 years
|
|
intensive bleeding
大体时间：Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years
|
phone survey when patients are invited to the clinic.
|
Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
frequency of thromboembolic events
大体时间：in 1-2-3-6 years after the anticoagulant therapy is prescribed
|
patients will be surveyed upon their visit to the clinic.
Thromboembolic events shall mean non-fatal embolic strokes, systemic embolism, acute coronary syndrome (to be corroborated with documents).
|
in 1-2-3-6 years after the anticoagulant therapy is prescribed
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
minor bleeding
大体时间：in 1-2-3-6 years after the anticoagulant therapy is prescribed
|
Minor bleeding shall mean any visually observed bleeding, including that discovered with various imaging methods, which cause a decrease in HB by less than 30 GM/DL or Ht by less than 9%.
|
in 1-2-3-6 years after the anticoagulant therapy is prescribed
|
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。
调查人员
- 首席研究员：Zukhra Salpagarova、I.M. Sechenov First Moscow State Medical University (Sechenov University)
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
2014年1月15日
初级完成 (实际的)
2021年3月2日
研究完成 (实际的)
2021年3月2日
研究注册日期
首次提交
2021年3月3日
首先提交符合 QC 标准的
2022年3月31日
首次发布 (实际的)
2022年4月8日
研究记录更新
最后更新发布 (实际的)
2022年4月8日
上次提交的符合 QC 标准的更新
2022年3月31日
最后验证
2021年3月1日
更多信息
与本研究相关的术语
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
ethics committee requirement
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.
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