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Warfarin Dosage Adjustment Model Analysis Study

Sponsor
Chinese University of Hong Kong (Other)
Overall Status
Recruiting
CT.gov ID
NCT05609500
Collaborator
Professor Bryan Ping Yen YAN (byan) (Other)
1,200
Enrollment
1
Location
15.5
Anticipated Duration (Months)
77.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Warfarin dosage adjustment model

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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
1200 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Warfarin Dosage Adjustment for Outside Therapeutic Range: a Linear Regression Model Analysis
Actual Study Start Date :
Sep 6, 2022
Anticipated Primary Completion Date :
Sep 6, 2023
Anticipated Study Completion Date :
Dec 23, 2023

Outcome Measures

Primary Outcome Measures

  1. extreme outside therapeutic range [1 year]

    INR<1.5 or INR>3.5 on two consecutive blood checking

Secondary Outcome Measures

  1. the time needed to achieve within therapeutic range [1 year]

    It 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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 exclusion criteria

Contacts and Locations

Locations

Site City State Country Postal Code
1 Prince of Wales Hospital Hong Kong Shatin Hong Kong 0000

Sponsors and Collaborators

  • Chinese University of Hong Kong
  • Professor Bryan Ping Yen YAN (byan)

Investigators

  • Study Chair: Bryan Yan, Chinese University of Hong Kong
  • Study Chair: Guangming Tan, Chinese University of Hong Kong

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gormin Tan, Assistant professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT05609500
Other Study ID Numbers:
  • 2022.370
First Posted:
Nov 8, 2022
Last Update Posted:
Nov 8, 2022
Last Verified:
Nov 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gormin Tan, Assistant professor, Chinese University of Hong Kong
Warfarin
dosage adjustment
therapeutic range
linear regression model
Additional relevant MeSH terms:
Warfarin

Study Results

No Results Posted as of Nov 8, 2022