Point-of-Care Testing (POCT) for Guided Precision Anticoagulation With Warfarin: A Multicenter, Non-concurrent Controlled Study
October 14, 2024 updated by: RenJi Hospital
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.
Study Overview
Study Type
Interventional
Enrollment (Estimated)
416
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: XIN WANG
- Phone Number: 13052395835
- Email: 15656594127@163.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: POCT group
|
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.
|
|
No Intervention: pyrosequencing group
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
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 Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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.
|
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
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.
|
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
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.
|
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
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.
|
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
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.
|
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.
|
|
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.
|
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.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
January 1, 2025
Primary Completion (Estimated)
December 31, 2025
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
October 14, 2024
First Submitted That Met QC Criteria
October 14, 2024
First Posted (Actual)
October 16, 2024
Study Record Updates
Last Update Posted (Actual)
October 16, 2024
Last Update Submitted That Met QC Criteria
October 14, 2024
Last Verified
October 1, 2024
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- IIT-2024-0271
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.