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

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-006238-87-GB

Enrollment

180

Registered

2009-10-14

Start date

2010-01-22

Completion date

Unknown

Last updated

2019-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients will be recruited who are receiving long term warfarin therapy for the treatment or prevention of venous or arterial thrombosis or embolism

Interventions

Product Name: Warfarin Pharmaceutical Form: Tablet Product Name: Vitamin K1 (phylloquinone/phytomenadione) Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route o

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026