Anticoagulation
Conditions
Keywords
warfarin, POCT, Genetic test
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.
Interventions
GENETICPOCT 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.
Sponsors
RenJi Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The time it takes for patients to reach the target INR range (INR 2.0-3.0). | 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
| Measure | Time frame |
|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
Contacts
Primary ContactXIN WANG
Outcome results
None listed