Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:45 PM
Study NCT ID:
NCT01042067
Status:
SUSPENDED
Last Update Posted:
2011-04-27
First Post:
2010-01-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safer Warfarin Treatment
Sponsor:
Oslo University Hospital
Organization:
Study Overview
Official Title:
Safer Warfarin Treatment - the Influence of CYP2C9 Genotyping, Genotyping of Vitamine K Dependent Proteins and Dietary Vitamine K Status on Dosing, Clinical Effect and Adverse Events With Emphasis on the Initial Phase of Treatment
Status:
SUSPENDED
Status Verified Date:
2011-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Enrolling participants has halted due to lack of investigator.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CYKOWAR
Brief Summary:
The study is a national multicenter prospective observational study, including 200 patients. The main purpose of this study is to explore in more detail the influence of genetic variability (CYP enzymes and vitamin K dependent proteins) and dietary vitamin K status on warfarin dosing, clinical effect and adverse events with emphasis on the initial phase of treatment. The hypothesis is that genetic variability concerning CYP enzymes and vitamin K dependent proteins predict dosing and adverse events during warfarin treatment. The main aim is to individualize warfarin therapy and establish a treatment algorithm based on genotype and dietary vitamin K status to make the anticoagulation therapy with warfarin more secure.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: