Clinical trial NCT06645275: Point-of-Care Testing (POCT) for Guided Precision Anticoagulation With Warfarin: A Multicenter, Non-concurrent Controlled Study
Official title: Point-of-Care Testing (POCT) for Guided Precision Anticoagulation With Warfarin: A Multicenter, Non-concurrent Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Anticoagulation
Keywords: warfarin
POCT
Genetic test
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2024-10-16
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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;

Exclusion Criteria:

* 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).

Primary outcomes:
measure: The time it takes for patients to reach the target INR range (INR 2.0-3.0).
timeFrame: 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.
Secondary outcomes:
measure: Percentage of time within the therapeutic range (TTR)
timeFrame: 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.
measure: Number of warfarin dose adjustments within 90 days
timeFrame: 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.
measure: Number of times INR is below 2.0 or above 3.0 within 90 days
timeFrame: 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.
measure: Thrombotic events
timeFrame: 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.
measure: Cost-effectiveness analysis of POCT and pyrosequencing test
timeFrame: 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.
measure: bleeding events
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
References: