anticoagulation Vitamin K antagonists Point-of-care Time in therapeutic range
Conditions
Interventions
We will perform a single-center, prospective, open-label, randomized clinical trial, to determine if switching from acenocoumarol to phenprocoumon can improve time in therapeutic range during POC INR
Sponsors
Erasmus University Medical Center
Eligibility
Inclusion criteria
Inclusion criteria: 1.Provision of informed consent prior to any study specific procedures. 2.Patients with an indication for anticoagulant treatment with vitamin K antagonists who are treated with acenocoumarol. 3. Patients aged 18 years or above. 4. The patient has a target INR of 3.0 (therapeutic range 2.0-3.5) or 3.5 (therapeutic range 2.5-4.0) 5. The patient has an expected treatment duration of 6 months or longer from the moment of study entry 6. The patient is expected to have at least 3 months of treatment with VKA’s before study entry
Exclusion criteria
Exclusion criteria: 1. Patients who self-monitor their INR. 2. Patients who are treated with VKA other than acenocoumarol. 3. The patients’ life expectancy is less than 6 months. 4. Pregnant women, women who are breast feeding, and women of childbearing potential who are not intending to practice an adequate method of contraception during their participation in the study. 5. Patients with a scheduled chirurgical procedure during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of time in therapeutic range at study end | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. INR testing frequency 2. Percentage of measurements in therapeutic range 3. Percentage of INR followed by a significant dose adjustments, defined as any dose adjustment of 10% or more 4. Percentage INR variation 5. Difference in treatment satisfaction score (0-100), based on the visual analogue scale at study end | — |
Contacts
Public ContactJ.S. Biederman
Erasmus MC - kamer NC-816 - Wytemaweg 80
Outcome results
None listed