Improving the safety and efficacy of anticoagulation therapy

Improving the safety and efficacy of anticoagulation therapy for thromboembolic disease through vitamin K: a single centre randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN64826232

Enrollment

180

Registered

2010-10-21

Start date

2010-07-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Topic: Blood

Interventions

Randomised (blinded) to vitamin K/placebo 150 µg orally once daily for 6 months. Follow-up at 1, 2, 4, 8, 12, 16, 20, and 24 weeks post initial dose.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Long term warfarin therapy 2. Aged greater than or equal to 18 years 3. Male and female

Exclusion criteria

Exclusion criteria: 1. Abnormal hepatic or renal function 2. Impairment of cognitive function

Design outcomes

Primary

Measure	Time frame
Percent time within target INR (calculated by the method of interpolation) for the study period, measured at baseline and weeks 1, 2, 4, 8, 12, 16, 20 and 24 weeks.	—

Secondary

Measure	Time frame
1. Clinical events of major (defined as bleeding that led to loss of 2 units of blood over a 7 day period 2. Days attending anticoagulation clinic to monitor and achieve target International Normalised Ratio (INR) 3. Markers of lack of efficacy including recurrent thrombosis 4. The number of warfarin dose changes 5. Quality of life questionnaires recorded at baseline and repeated at the end of the study	—

Measure

Time frame

1. Clinical events of major (defined as bleeding that led to loss of 2 units of blood over a 7 day period 2. Days attending anticoagulation clinic to monitor and achieve target International Normalised Ratio (INR) 3. Markers of lack of efficacy including recurrent thrombosis 4. The number of warfarin dose changes 5. Quality of life questionnaires recorded at baseline and repeated at the end of the study

—

Countries

United Kingdom

Outcome results

None listed

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