Safer Warfarin Treatment

NCT01042067 | Suspended

• 1 other identifier: 2006-001895-18
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

warfarin; genotyping; vitamin K; dosing; adverse events; initial phase of treatment; algorithm

Study Arms (1)

Warfarin treatment group

Open label study. Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment.

Other: Blood specimens (whole blood, serum, plasma)

Interventions

Blood specimens (whole blood, serum, plasma) OTHER

The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.

Warfarin treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment. About 200 patients will be included.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• University of Oslo: collaborator
• Norwegian Medicines Agency: collaborator
• Norway: South-Eastern Norway Regional Health Authority: collaborator

Study Sites (1)

Oslo University Hospital

Oslo, N-0407, Norway

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, serum, plasma

MeSH Terms

Conditions

Atrial Fibrillation; Venous Thrombosis; Pulmonary Embolism

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Lung Diseases; Respiratory Tract Diseases; Embolism

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 4, 2010
• First Posted: January 5, 2010
• Study Start: January 1, 2010
• Last Updated: April 27, 2011

Record last verified: 2011-04

Locations

NO (1)