Safer Warfarin Treatment

Atrial Fibrillation Clinical Trial

— CYKOWAR  

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01042067
• Other study ID #: 2006-001895-18
• Status: Suspended
• Phase: N/A
• First received: January 4, 2010
• Last updated: April 26, 2011
• Start date: January 2010

Study information

• Verified date: April 2011
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Medicines AgencyNorway: Norwegian Social Science Data ServicesNorway: Direcorate for Health and Social Affairs
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 200
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Caucasian

• >18 years of age

• included in the study at the onset of warfarin treatment

• target INR (2-3 for atrial fibrillation, vein thrombosis, pulmonary embolism and 2.5-3.5 for prosthetic heart valves)

• standard indications for warfarin treatment

Exclusion Criteria:

• Non-caucasian

• Clinical significant liver affection

• Heart failure, NYHA class III-IV

• Non-compliant - not able to accomplish protocol demands

• Not able to give informed consent

• Long-term antibiotic therapy

• Malabsorption conditions and inflammatory bowel disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Heart Valve Prosthesis
• Pulmonary Embolism
• Venous Thrombosis

Intervention

Other:
• Blood specimens (whole blood, serum, plasma)
The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Oslo University Hospital	Norway: South-Eastern Norway Regional Health Authority, Norwegian Medicines Agency, University of Oslo

Country where clinical trial is conducted

Norway,