Optimization of Anticoagulant Therapy in Outpatient Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,000
- 主要终点
- death due to any cause
研究概览
简要总结
Single-institution uncontrolled open-label trial.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the age above 18
- •indications for the anticoagulant therapy
- •informed consent for inclusion into trials
排除标准
- •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
结局指标
主要结局
death due to any cause
时间窗: in six years after the anticoagulant therapy is prescribed
phone survey when patients are invited to the clinic
kidney compliance with the anticoagulant therapy and its safety and trends in the kidney function
时间窗: 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
cardiovascular mortality
时间窗: 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.
kidney function trend
时间窗: 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
intensive bleeding
时间窗: Evaluation of GFR, bleeding and thrombotic complications and cardiac mortality after 6 years
phone survey when patients are invited to the clinic.
次要结局
- frequency of thromboembolic events(in 1-2-3-6 years after the anticoagulant therapy is prescribed)