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

Shanghai Jiao Tong University

Status and phase

Not yet enrolling

Phase 4

Conditions

Anticoagulation

Treatments

Genetic: POCT test

Study type

Interventional

Funder types

Other

Identifiers

NCT06645275

IIT-2024-0271

Details and patient eligibility

About

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.

Enrollment

416 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).