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

NCT06645275 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: IIT-2024-0271
• Study Type: interventional
• Target: 416
• Locations: 0 countries
• Sites: N/A

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

Keywords

warfarin; POCT; Genetic test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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.

Study Arms (2)

POCT group

EXPERIMENTAL

Genetic: POCT test

pyrosequencing group

NO INTERVENTION

Interventions

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.

POCT group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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).

Sponsors & Collaborators

• RenJi Hospital: lead

Central Study Contacts

XIN WANG

CONTACT

13052395835; 15656594127@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2024
• First Posted: October 16, 2024
• Study Start: January 1, 2025
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share