Point-of-Care Testing (POCT) for Guided Precision Anticoagulation With Warfarin: A Multicenter, Non-concurrent Controlled Study

Обзор

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.

Вмешательства

• Генная терапия POCT test
  Patients undergo POCT testing on the day of warfarin administration, and based on the POCT results, the initial and maintenance doses of warfarin are determined according to the IWPC algorithm.

Первичные конечные точки

• The time it takes for patients to reach the target INR range (INR 2.0-3.0). [Срок оценки: 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.]

Вторичные конечные точки (6)

• Percentage of time within the therapeutic range (TTR) [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06645275 · IIT-2024-0271

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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