An investigation of the association between vitamin K intake, vitamin K epoxide reductase subunit (VKORC1) genotype and anticoagulation response to warfarin - How do vitamin K intake and VKOR genotype affect oral anticoagulation?

Phase 1

• Conditions: Patients will be recruited who are receiving long term warfarin therapy for the treatment or prevention of venous or arterial thrombosis or embolism; MedDRA version: 9.1Level: LLTClassification code 10043566Term: Thromboembolism

• Registration Number: EUCTR2008-006451-52-GB
• Lead Sponsor: ewcastle upon Tyne Hospitals NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2009-02-27
• Study Completion: 2012-03-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

Patient being on warfarin for 9 months or more (so that percentage time in target range over the previous 6 months is not affected by the induction period of therapy where the correct maintenance dose is being established), and a target INR of 2.5.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Starting or stopping medication during the 6 months prior to study entry that might have interfered with warfarin, or having an illness during this time which might have affected warfarin dose, or having issues known to result in compliance with warfarin therapy being unreliable.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified