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

ConditionAnticoagulation

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18+

SponsorRenJi Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

POCT test
Genetic
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.

Treatment groups

416 Participants

are divided into 2 treatment groups

Group A: POCT groupExperimental treatment 1 intervention

Group B: pyrosequencing groupNo intervention 0 interventions