No registrations found.
ID
Source
Brief title
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Quality of anticoagulant treatment;
2. Expressed as time in therapeutic range.
Secondary outcome
1. Number of INRs in therapeutic range;
2. Bleeding and thromboembolic complications.
Background summary
Background:
It has been shown that oral anticoagulant control is less stable at a low dietary intake of vitamin K.
We hypothesize that a low dose vitamin K supplement results in a more stable anticoagulation in patients using vitamin K antagonists.
The primary objective of this study:
is to test this hypothesis clinically.
Methods:
The study is a double blind, randomized, placebo controlled trial in patients who use phenprocoumon and have an indication for long-term oral anticoagulant treatment.
Two hundred patients will be randomized to receive adjusted-dose phenprocoumon and a daily vitamin K supplement of 100 micrograms or to receive adjusted-dose phenprocoumon and placebo for 24 weeks.
The primary endpoint is the percentage of time the INR is within the therapeutic range.
Study objective
1. Oral anticoagulant control is less stable at a low average intake of vitamin K;
2. As a consequence, a low dose vitamin K supplement results in a more stable anticoagulant effect in patients using vitamin K antagonists (VKA);
3. Dietary intake of vitamin K is associated with sensitivity to VKA and stability of anticoagulant treatment;
4. Polymorphisms of the VKORC1 gene are associated with sensitivity to VKA and stability of anticoagulant treatment.
Study design
N/A
Intervention
1. Treatment group: 100 microgram vitamin K for 24 weeks;
2. Placebo group: placebo for 24 weeks.
Department of Hematology,
P.O. Box 9600
Eva Rombouts
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5264798
e.k.rombouts@lumc.nl
Department of Hematology,
P.O. Box 9600
Eva Rombouts
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5264798
e.k.rombouts@lumc.nl
Inclusion criteria
1. Patients treated at the Leiden anticoagulation clinic with an indication for long-term oral anticoagulant therapy using the vitamin K antagonist phenprocoumon;
2. Age between 18 and 80 years;
3. Informed consent.
Exclusion criteria
1. Treatment by a medical specialist for liver failure;
2. Haemo- or peritoneal dialysis;
3. Pregnancy or a planned pregnancy, puerperium;
4. Any chronic condition with an expected median survival of less than 6 months
an expectedinterruption of oral anticoagulant treatment of more than 1 week;
5. Self-management of oral anticoagulant therapy;
6. Other drugs affecting hemostasis (aspirin, heparin, clopidogrel).
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL276 |
| NTR-old | NTR314 |
| Other | : project 2005.2 |
| ISRCTN | ISRCTN14473912 |