NCT06645275尚未招募4 期
Point-of-Care Testing (POCT) for Guided Precision Anticoagulation With Warfarin: A Multicenter, Non-concurrent Controlled Study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 416
- 主要终点
- The time it takes for patients to reach the target INR range (INR 2.0-3.0).
研究概览
简要总结
This study aims to compare the key clinical indicators such as the time to achieve INR target, frequency of dose adjustment, and the incidence of thrombotic and hemorrhagic events between Point-of-Care Testing (POCT) and pyrosequencing technology in the precision dosing of warfarin, in order to assess whether POCT-based warfarin genetic testing is beneficial for improving the quality of anticoagulation treatment for patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years, gender unrestricted;
- •Inpatients in the cardiology department and cardiovascular surgery department who are using warfarin for the first time and require continuous treatment for at least 3 months;
- •The patient or legal guardian agrees to the research plan and signs an informed consent form;
排除标准
- •Patients with contraindications to anticoagulant therapy or those who are scheduled for surgery in the near future;
- •Known genotypes CYP2C9 or VKORC1;
- •Patients scheduled to undergo interventional procedures (such as radiofrequency ablation, cardiac defibrillation) in the near future;
- •Patients with hematological disorders, bleeding disorders, or a tendency to bleed;
- •Patients with severe liver and kidney dysfunction (CrCl < 15ml/min);
- •Patients with concurrent tumors, severe immune system diseases, or other terminal diseases;
- •Patients with severe heart failure (NYHA Class IV) or severe anemia (hemoglobin < 60g/L);
- •Pregnant and lactating women;
- •Uncontrolled hypertension (systolic blood pressure > 180mmHg or diastolic blood pressure > 120mmHg).
结局指标
主要结局
The time it takes for patients to reach the target INR range (INR 2.0-3.0).
时间窗: Patients will be scheduled for outpatient clinic or phone visits at intervals of 2, 4, 6,13,20,35,60 and 90 day following enrollment.
次要结局
- Percentage of time within the therapeutic range (TTR)(Patients will be scheduled for outpatient clinic or phone visits at intervals of 2, 4, 6,13,20,35,60 and 90 day following enrollment.)
- Number of warfarin dose adjustments within 90 days(Patients will be scheduled for outpatient clinic or phone visits at intervals of 2, 4, 6,13,20,35,60 and 90 day following enrollment.)
- Number of times INR is below 2.0 or above 3.0 within 90 days(Patients will be scheduled for outpatient clinic or phone visits at intervals of 2, 4, 6,13,20,35,60 and 90 day following enrollment.)
- Thrombotic events(Patients will be scheduled for outpatient clinic or phone visits at intervals of 2, 4, 6,13,20,35,60 and 90 day following enrollment.)
- Cost-effectiveness analysis of POCT and pyrosequencing test(Patients will be scheduled for outpatient clinic or phone visits at intervals of 2, 4, 6,13,20,35,60 and 90 day following enrollment.)
- bleeding events(Patients will be scheduled for outpatient clinic or phone visits at intervals of 2, 4, 6,13,20,35,60 and 90 day following enrollment.)
研究者
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