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Warfarin Dosage Adjustment Model Analysis Study

Warfarin Dosage Adjustment for Outside Therapeutic Range: a Linear Regression Model Analysis

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05609500
Enrollment
1200
Registered
2022-11-08
Start date
2022-09-06
Completion date
2023-12-23
Last updated
2022-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Warfarin

Keywords

Warfarin, dosage adjustment, therapeutic range, linear regression model

Brief summary

Despite the wide availability of Direct oral anticoagulation (DOAC), warfarin remains an important oral anticoagulant1 especially in patients with mechanical valve replacement or chronic renal failure where the evidence of DOAC is limited. However, the dosing of warfarin is challenging as it has a narrow therapeutic index and is highly influenced by dietary vitamin K intake and drugs that interacts with cytochrome (CYP) P4501. The time outside therapeutic range will carry the risk of adverse events such as thrombosis and bleeding. Numerous algorithms have been proposed that utilized either clinical or pharmacogenetics factors. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has recommended the use of 4 dosing algorithms. However, these algorithms require the input of genetic information such as CYP2C9 and VKORC1 type which are not widely available locally and are less relevant in maintenance phase. Furthermore, these algorithms target mainly at predicting the initiation and the maintenance dose of warfarin. This has provided us with the opportunities to explore the Prediction model for on-treatment warfarin dose titration for outside therapeutic range.

Detailed description

Despite the wide availability of Direct oral anticoagulation (DOAC), warfarin remains an important oral anticoagulant1 especially in patients with mechanical valve replacement or chronic renal failure where the evidence of DOAC is limited. However, the dosing of warfarin is challenging as it has a narrow therapeutic index and is highly influenced by dietary vitamin K intake and drugs that interacts with cytochrome (CYP) P4501. The time outside therapeutic range will carry the risk of adverse events such as thrombosis and bleeding. Numerous algorithms have been proposed that utilized either clinical or pharmacogenetics factors. The Clinical Pharmacogenetics Implementation Consortium (CPIC) has recommended the use of 4 dosing algorithms. However, these algorithms require the input of genetic information such as CYP2C9 and VKORC1 type which are not widely available locally and are less relevant in maintenance phase. Furthermore, these algorithms target mainly at predicting the initiation and the maintenance dose of warfarin. This has provided us with the opportunities to explore the Prediction model for on-treatment warfarin dose titration for outside therapeutic range.

Interventions

BEHAVIORALWarfarin dosage adjustment model

Warfarin dosage adjustment model use to predict the initiation and the maintenance dose of warfarin. Variation of warfarin dose during stable maintenance phase for the same patient might be influenced more by temporal factors such as modification of drug regimens that utilize the CYP450 pathway, or dietary vitamin K intake

Sponsors

Professor Bryan Ping Yen YAN (byan)
CollaboratorUNKNOWN
Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

1. Patients who have been on maintenance warfarin treatment 2. Patients whose INR have fallen outside therapeutic range will be identified using CDARS enquiry

Exclusion criteria

1\. No

Design outcomes

Primary

MeasureTime frameDescription
extreme outside therapeutic range1 yearINR\<1.5 or INR\>3.5 on two consecutive blood checking

Secondary

MeasureTime frameDescription
the time needed to achieve within therapeutic range1 yearIt is calculated by the time interval from the outside therapeutic range INR to final within therapeutic range INR, the number of INRs checking between the initial outside therapeutic range and the final within therapeutic range

Countries

Hong Kong

Contacts

Primary ContactDaniel Xu
danielxu@cuhk.edu.hk35051518

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026