Improving the safety and efficacy of anticoagulation therapy for thromboembolic disease through vitamin K - Improving stability of anticoagulation through vitamin K

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

• Registration Number: EUCTR2008-006238-87-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: 2009-10-14
• Study Completion: 2012-11-15
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Adult patients with indications for at least 6 months anticoagulation therapy with warfarin with target INR 2-3 attending the Newcastle upon Tyne Anticoagulant Monitoring Service.
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

Abnormal biochemical tests of hepatic or renal function, cognitive impairment.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: Warfarin inhibits the activation of clotting factors by inhibiting the regeneration of vitamin K in the vitamin K cycle. Patients anticoagulated with warfarin are very sensitive to intake of vitamin K. We have demonstrated that daily supplementation with 150 µg vitamin K of patients with unstable control significantly increased the time they spent in their therapeutic anticoagulation range. We hypothesise that daily supplementation with vitamin K would reduce bleeding and thromboembolism in the anticoagulated population and, as a pilot investigation to a multicentre study to assess this, aim to measure the impact of vitamin K on stability of control in an unselected anticoagulated cohort.;Secondary Objective: ;Primary end point(s): Percentage time within target INR range during the 6 month period of study.