Ignite Creation Date:
2024-05-06 @ 6:16 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05609500
Status:
RECRUITING
Last Update Posted:
2022-11-08
First Post:
2022-11-02
Brief Title:
Warfarin Dosage Adjustment Model Analysis Study
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Warfarin Dosage Adjustment for Outside Therapeutic Range a Linear Regression Model Analysis
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None