Ignite Creation Date:
2024-05-06 @ 12:42 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01633957
Status:
UNKNOWN
Last Update Posted:
2016-07-25
First Post:
2012-06-20
Brief Title:
A Trial of Genotype-based Warfarin Initiation in Patients With Mechanical Prosthetic Heart Valve
Sponsor:
Xi Zhang
Organization:
First Affiliated Hospital Sun Yat-Sen University
Study Overview
Official Title:
Academic LeaderHead of Cardiac SurgeryPrincipal Investigator Clinical Professor
Status:
UNKNOWN
Status Verified Date:
2016-07
Last Known Status:
RECRUITING
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:
SYSU-WARFA
Brief Summary:
Until very recently warfarin is still the best drug of choice for long-term anticoagulation for patients with mechanical prosthetic heart valve However the complication of warfarin account for 75 percent of the whole complication after the mechanical prosthetic heart valve replacement
Interindividual variation in warfarin dose is mediated by multiple factorsAdvanced models using combinations of clinical attributes and genetic factorsCYP2C9 VKORC1 and CYP4F2 explain 50-75 of variability in warfarin dose requirementsThese warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events The investigators conducted a prospective randomized blinded two arm trial to test this hypothesis
Interindividual variation in warfarin dose is mediated by multiple factorsAdvanced models using combinations of clinical attributes and genetic factorsCYP2C9 VKORC1 and CYP4F2 explain 50-75 of variability in warfarin dose requirementsThese warfarin dosing models have the potential to improve patient safety by reducing or eliminating serious adverse events The investigators conducted a prospective randomized blinded two arm trial to test this hypothesis
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