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

NCT ID: NCT06645275

Last Updated: 2024-10-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 416 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2026-03-31

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.

Conditions

Anticoagulation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

POCT group

Group Type: EXPERIMENTAL

POCT test

Intervention Type: 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.

pyrosequencing group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

POCT 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.

Intervention Type: GENETIC

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

XIN WANG

Role: CONTACT

15656594127@163.com

13052395835

Other Identifiers

IIT-2024-0271

Identifier Type: -

Identifier Source: org_study_id