Ignite Creation Date:
2024-05-06 @ 2:31 AM
Last Modification Date:
2024-10-26 @ 11:19 AM
Study NCT ID:
NCT02065388
Status:
COMPLETED
Last Update Posted:
2014-02-19
First Post:
2014-02-09
Brief Title:
Pharmacogenetic Dosing of Warfarin
Sponsor:
Academia Sinica Taiwan
Organization:
Academia Sinica Taiwan
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2014-02
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:
Purpose
Warfarin is now the most commonly used oral anticoagulant This drug has inter-individual variability due to the genetic polymorphisms in the warfarin metabolizing enzyme CYP2C9 and warfarin target VKORC1 The investigators team developed a pharmacogenetic dosing algorithm which can predict patients required warfarin dose thus could prevent warfarin induced warfarin adverse events
Methods
The investigators recruited patients with indications for warfarin the genotypes of VKORC1 and CYP2C9 were determined by the hospitals and verified by National Center for Genome Medicine The investigators then randomized the patients to one of three arms 1 Warfarin dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic Consortium IWPC 2 Algorithm developed by the Taiwan Warfarin Consortium and 3 Standard of care The investigators aimed to determine whether using genetic dosing algorithm can lead to more stable dose and safer use of the drug
Warfarin is now the most commonly used oral anticoagulant This drug has inter-individual variability due to the genetic polymorphisms in the warfarin metabolizing enzyme CYP2C9 and warfarin target VKORC1 The investigators team developed a pharmacogenetic dosing algorithm which can predict patients required warfarin dose thus could prevent warfarin induced warfarin adverse events
Methods
The investigators recruited patients with indications for warfarin the genotypes of VKORC1 and CYP2C9 were determined by the hospitals and verified by National Center for Genome Medicine The investigators then randomized the patients to one of three arms 1 Warfarin dose predicted by dosing algorithm developed by the International Warfarin pharmacogenetic Consortium IWPC 2 Algorithm developed by the Taiwan Warfarin Consortium and 3 Standard of care The investigators aimed to determine whether using genetic dosing algorithm can lead to more stable dose and safer use of the drug
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None