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Warfarin Dosage Adjustment Model Analysis Study

NCT05609500 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1200

Last updated 2022-11-08

No results posted yet for this study

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.

Conditions

  • Warfarin

Interventions

BEHAVIORAL

Warfarin 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 & Collaborators

  • Professor Bryan Ping Yen YAN (byan)

    collaborator UNKNOWN

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Bryan Yan · Chinese University of Hong Kong

  • Guangming Tan · Chinese University of Hong Kong

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-06
Primary Completion
2023-09-06
Completion
2023-12-23

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609500 on ClinicalTrials.gov