Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06645275

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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.

Primary outcomes

  1. The time it takes for patients to reach the target INR range (INR 2.0-3.0).

    Time frame: 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

  1. Percentage of time within the therapeutic range (TTR)

    Time frame: 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.

  2. Number of warfarin dose adjustments within 90 days

    Time frame: 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.

  3. Number of times INR is below 2.0 or above 3.0 within 90 days

    Time frame: 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.

  4. Thrombotic events

    Time frame: 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.

  5. Cost-effectiveness analysis of POCT and pyrosequencing test

    Time frame: 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.

  6. bleeding events

    Time frame: 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 contacts

Contact information is provided by the study sponsor or research team.

XIN WANG

CONTACT

[email protected]

13052395835

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Oct 16, 2024
Registry last updated
Oct 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.