Safer Warfarin Treatment (CYKOWAR)

This study has suspended participant recruitment.
(Enrolling participants has halted due to lack of investigator.)
Sponsor:
Collaborators:
University of Oslo
Norwegian Medicines Agency
Norway: South-Eastern Norway Regional Health Authority
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01042067
First received: January 4, 2010
Last updated: April 26, 2011
Last verified: April 2011
  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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT01042067     History of Changes
Other Study ID Numbers: 2006-001895-18
Study First Received: January 4, 2010
Last Updated: April 26, 2011
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Norwegian Medicines Agency
Norway: Norwegian Social Science Data Services
Norway: Direcorate for Health and Social Affairs

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

Additional relevant MeSH terms:
Atrial Fibrillation
Pulmonary Embolism
Thrombosis
Venous Thromboembolism
Venous Thrombosis
Arrhythmias, Cardiac
Cardiovascular Diseases
Embolism
Embolism and Thrombosis
Heart Diseases
Lung Diseases
Pathologic Processes
Respiratory Tract Diseases
Thromboembolism
Vascular Diseases
Warfarin
Anticoagulants
Hematologic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 21, 2014