Lowering anticoagulant effect of vitamin K antagonists in case of over-anticoagulation or pending diagnostic or therapeutic invase action. MedDRA version: 12.1 Level: LLT Classification code 10053755 Term: Vitamin K antagonist MedDRA version: 12.1 Level: LLT Classification code 10058768 Term: Vitamin K MedDRA version: 12.1 Level: LLT Classification code 10011970 Term: Decreased INR MedDRA version: 12.1 Level: LLT Classification code 10037818 Term: Raised INR
Conditions
Interventions
Trade Name: Phytomenadion
Product Name: phytomenadion
Product Code: 84800
Pharmaceutical Form: Oral solution
INN or Proposed INN: PHYTOMENADIONE
CAS Number: 84-80-0
Other descriptive name: Vitamin K1
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Minimal 18 years of age. - Step 1: healthy volunteer. - Step 2: patient being treated with phenprocoumon undergoing an invasive diagnostic or therapeutic procedure for which reducing of the INR is necessary. - Step 3: patient being treated with phenprocoumon having an INR between 7.0 and 10.0 for which reducing with vitamin K is necessary. 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: - Being treated for liver failure. - Pregancy, pregnancy wish or lactational period. - Dialysis (both hemodialysis and peritoneal dialysis) - Participation in the self management program. - Inability to take care of own medication and / or proven non-compliance with treatment protocols.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether or not there is a difference in biological availibility between vitamin K1 solution in oil or vitamin K1 tablets. ;Secondary Objective: To assess whether or not there is a difference in effectiveness between vitamin K1 solution in oil or vitamin K1 tablets.;Primary end point(s): Step 1: The difference between vitamin K1 levels in blood 4 hours after taking vitamin K1 tablets in comparisson with vitamin K1 solution in oil. The difference in the area under the curve meassured over 24 hours after taking vitamin K1 tablets in comparisson with vitamin K1 solution in oil. Step 2: The difference in the number of INR-values lower than 2.0 when comparing vitamin K1 tablets with vitamin K1 solution in oil after 24 and 48 hours. Step 3: The difference in the decrease of the INR-values 24 hours after taking either vitamin K1 tablets or vitamin K1 solution in oil. The difference in the number of INR-values lower than 2.0 when comparing vitamin K1 tablets with vitamin K1 solution in oil after 24 and 48 hours. The difference in increase of the vitamin K levels in the blood 24 hours after taking either vitamin K1 tablets or vitamin K1 solution in oil. | — |
Countries
Netherlands
Outcome results
None listed