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

Phase 4Not Yet RecruitingNCT06645275

RenJi Hospital416 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

416

Conditions

Anticoagulation

Interventions

POCT testGENETIC

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).