Anti-coagulationtreatment with vitamine K antagonists. MedDRA version: 9.1 Level: LLT Classification code 10058768 Term: Vitamin K MedDRA version: 9.1 Level: LLT Classification code 10053755 Term: Vitamin K antagonist MedDRA version: 9.1 Level: HLT Classification code 10009728 Term: Coagulation and bleeding analyses MedDRA version: 9.1 Level: LLT Classification code 10043607 Term: Thrombosis
Conditions
Interventions
Trade Name: Phytomenadion
Product Name: phytomenadion
Product Code: 84800
Pharmaceutical Form: Capsule*
INN or Proposed INN: PHYTOMENADIONE
CAS Number: 84800
Other descriptive name: Vitamin K
Concentr
Sponsors
Dutch Heart Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Start treatment with vitamin K antagonists less then 4 weeks before inclusion. 2. Treatment with vitamin K antagonists for a minimal period of 6 months, with the therapeutic range of INR between 2.5 and 3.5. 3. Age between 18 and 85 years. 4. Measurement of the INR by the Thrombosis Service Leiden. 5. Informed consent. 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: 1. Treatment for liver failure. 2. Dialysys, both peritoneal as hemodialysys. 3. Pregnancy or wish to get pregnant, lactational period. 4. Known to have a chronic condition with a life expectancy of less than 6 months. 5. An expected interruption of treatment with oral anticoagulants for one week or longer. 6. Participation of the self management protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether complications of treatment with vitamine K antagonists will decrease when vitamine K is given. To assess to optimal dosage of vitamine K for supplementation.;Secondary Objective: The possible influence of genetic polymorphisms of enzymes CYP2C9 and VKORC1 on the effect of vitamine K supplementation.;Primary end point(s): 1. The number of complications of treatment with vitamin K antagonists per patiëntyear in the group with vitamin K suppletion compared with the placebogroup. 2. The influence of genetic polymorphism of both CYP2C9 and VKORC1 on the effect of vitamin K suppletion while being treated with vitamin K antagonists. | — |
Countries
Netherlands
Outcome results
None listed