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

Phase 4

Not yet recruiting

• Conditions: Anticoagulation

• Registration Number: NCT06645275
• Lead Sponsor: RenJi Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study First Submitted: 2024-10-14
• Study First Submitted QC: 2024-10-14
• Last Update Submitted: 2024-10-14
• Study First Posted: 2024-10-16
• Last Update Posted: 2024-10-16
• Study Start: 2025-01-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-03-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 416

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.