AnticoagulationPhase 4NCT06645275
Point-of-Care Testing (POCT) for Guided Precision Anticoagulation With Warfarin: A Multicenter, Non-concurrent Controlled Study
A Phase 4 study testing POCT test in people with Anticoagulation, run by RenJi Hospital.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anticoagulation
- What is being tested?
- POCT test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2025to 31 Mar 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Show all 9Show fewer
- 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).
Trial locations and contacts
No sites are listed yet.
About this 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.
- Conditions
- Anticoagulation
- Being tested
- POCT test
- Keywords
- warfarin, POCT, Genetic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
POCT testGenetic
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.
| Study group | Role | What they receive |
|---|---|---|
| POCT group | Experimental | Not described Receives: Genetic: POCT test |
| pyrosequencing group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time it takes for patients to reach the target INR range (INR 2.0-3.0).
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2024
- Study start1 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnticoagulationStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06645275
- Sponsor's protocol ID
- IIT-2024-0271
- Status last verified
- Oct 2024
- First submitted
- 14 Oct 2024
- Last updated
- 16 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point-of-Care Testing (POCT) for Guided Precision Anticoagulation With Warfarin: A Multicenter, Non-concurrent Controlled Study
- ClinicalTrials.gov ID
- NCT06645275
- Acronym / sponsor ID
- IIT-2024-0271
- Conditions
- Anticoagulation
- Keywords
- warfarin, POCT, Genetic test
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 416 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 16 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| POCT group | Experimental | Genetic: POCT test |
| pyrosequencing group | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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;
Key exclusion criteria (9 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| POCT testPatients 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. | Genetic | POCT group |
Primary outcome
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.
6 secondary outcomes
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.
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.
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2024.
- Individual participant dataSharing planned: No
Related trials for Anticoagulation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
Ischemic Stroke, Atrial Fibrillation
RecruitingPhase 2
Safety in Adult Participants With Atrial Fibrillation Who Are Treated With Anticoagulation
Atrial Fibrillation (AF)
RecruitingPhase 3
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
Respiratory Tract Diseases, Influenza (Pandemic)
Recruiting
DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis
Venous Thromboembolism, Deep Venous Thrombosis
Active, not recruiting
Timing of Anticoagulation After Emergency Endovascular Therapy for Acute Ischemic Stroke With Atrial Fibrillation
Ischemic Stroke, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing POCT test in people with Anticoagulation, run by RenJi Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XIN WANG (13052395835, 15656594127@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.