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Safer Warfarin Treatment (CYKOWAR)

This study has suspended participant recruitment.
(Enrolling participants has halted due to lack of investigator.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01042067
First Posted: January 5, 2010
Last Update Posted: April 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Oslo
Norwegian Medicines Agency
Norway: South-Eastern Norway Regional Health Authority
Information provided by:
Oslo University Hospital
  Purpose
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.

Condition Intervention
Atrial Fibrillation Venous Thrombosis Pulmonary Embolism Heart Valve Prosthesis Other: Blood specimens (whole blood, serum, plasma)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Biospecimen Retention:   Samples With DNA
Whole blood, serum, plasma

Estimated Enrollment: 200
Study Start Date: January 2010
Groups/Cohorts Assigned Interventions
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)
The patients follow standard warfarin treatment regimens and the only intervention is the sampling of blood specimens.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01042067


Locations
Norway
Oslo University Hospital
Oslo, Norway, N-0407
Sponsors and Collaborators
Oslo University Hospital
University of Oslo
Norwegian Medicines Agency
Norway: South-Eastern Norway Regional Health Authority
  More Information

ClinicalTrials.gov Identifier: NCT01042067     History of Changes
Other Study ID Numbers: 2006-001895-18
First Submitted: January 4, 2010
First Posted: January 5, 2010
Last Update Posted: April 27, 2011
Last Verified: April 2011

Keywords provided by Oslo University Hospital:
warfarin
genotyping
vitamin K
dosing
adverse events
initial phase of treatment
algorithm

Additional relevant MeSH terms:
Atrial Fibrillation
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Embolism and Thrombosis
Vascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vitamins
Vitamin K
Warfarin
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Hemostatics
Coagulants