Newly diagnosed patients with venous tromboembolism (VTE) or atrial fibrillation (AF) requiring oral anticoagulation with phenprocoumon. MedDRA version: 12.1 Level: LLT Classification code 10003658 Term: Atrial fibrillation MedDRA version: 12.1 Level: LLT Classification code 10012107 Term: Deep venous thrombosis NOS MedDRA version: 12.1 Level: LLT Classification code 10037377 Term: Pulmonary embolism
Conditions
Interventions
Trade Name: acenocoumarol (various trade names)
Pharmaceutical Form: Tablet
INN or Proposed INN: ACENOCOUMAROL
CAS Number: 152-72-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concen
Sponsors
Democritus Universityof Thrace Medical School
University Utrecht
Fundacion Marques de Valdecilla
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with either venous thromboembolism (VTE) or atrial fibrillation (AF) requiring coumarin therapy for at least 12 weeks and a target INR in the low intensity range (INR range 2-3 in the United Kingdom, Sweden, Germany, Austria, Greece and Spain and INR 2.5-3.5 in the Netherlands) 2. Age = 18 years 3. Ability to attend scheduled visits 4. Signed 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. Abnormal clotting function at baseline (at least one of): a. INR >1.5 b. platelet count 1.3 times the upper reference value that is not explained by presence of lupus anticoagulants 2. Presence of a mechanical heart valve 3. Severe cognitive impairment 4. Known genotype CYP2C9 or VKORC1 at start of the study 5. Previous or current treatment with any coumarin 6. Pregnancy or lactation 7. Non-eligible subject, e.g. fysical or mental health problems.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint is the percent time within therapeutic INR range 2-3 during 12 weeks following the initiation of coumarin therapy. Our hypothesis is that pharmacogenetic guided dosing will increse the time within INR range if compared to non-pharmacogenetic guided dosing.;Primary end point(s): The percent time within therapeutic INR range 2-3 during 12 weeks following the initiation of coumarin therapy.;Secondary Objective: 1. Time to and number of patients with INR more than 4.0 2. % time spent above INR 4.0. 3. % time spent below INR 1.5, which indicates under-anticoagulation. 4. Time to reach therapeutic INR 5. Time to reach stable dose 6. Time to and number of bleeding events 7. Time to and number of thromboembolic events 8. The incidence of coumarin sensitivity 9. The incidence of coumarin resistance 10. Number of coumarin dose adjustments. 11. The clinical utility of the rapid genotyping test developed by LGC. 12. Quality of life (EQ-5D) 13. The cost-effectiveness of genotype-guided dosing for each coumarin compared with non-genotype-guided dosing. | — |
Countries
Netherlands
Outcome results
None listed