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Safer Warfarin Treatment (CYKOWAR)

University of Oslo (UIO) logo

University of Oslo (UIO)

Status

Suspended

Conditions

Pulmonary Embolism
Atrial Fibrillation
Heart Valve Prosthesis
Venous Thrombosis

Treatments

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

Study type

Observational

Funder types

Other

Identifiers

NCT01042067
2006-001895-18

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Warfarin treatment group
Description:
Open label study. Patients in need of warfarin treatment (standard indications) are included in the study at the onset of warfarin treatment.
Treatment:
Other: Blood specimens (whole blood, serum, plasma)

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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