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NCT05609500

Warfarin Dosage Adjustment Model Analysis Study

Status unknown Last updated 8 November 2022
What this trial tests

trial testing Warfarin dosage adjustment model in Warfarin in 1,200 participants. Status unknown.

Timeline
6 September 2022
Primary endpoint
6 September 2023
23 December 2023

Quick facts

Lead sponsorChinese University of Hong Kong
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment1,200
Start date6 September 2022
Primary completion6 September 2023
Estimated completion23 December 2023
Sites1 location across Hong Kong

Drugs / interventions tested

Conditions studied

Sponsor

Chinese University of Hong Kong

Who can join

Eligibility, any sex, with Warfarin. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Chinese University of Hong Kong trials

Trials by the same sponsor.

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