No registrations found.
ID
Source
Brief title
Health condition
anticoagulation
Vitamin K antagonists
Point-of-care
Time in therapeutic range
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of time in therapeutic range at study end
Secondary outcome
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
Study objective
Prior studies have shown reagent dependent differences in sensitivity to circulating clotting factor VII (FVII). This reagent dependent sensitivity to FVII can explain the INR differences between laboratory methods and point-of care devices found in earlier studies. Since FVII fluctuation and consequent INR variation is significantly lower in patients treated with the long-acting phenprocoumon compared to the short-acting acenocoumarol, switching patients from acenocoumarol to phenprocoumon may improve anticoagulant control during point-of-care INR monitoring
Study design
baseline and study end (7 months after study start)
Intervention
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 monitoring by a specialized anticoagulation clinic.
After informed consent, patients will be allocated to either switch to phenprocoumon or to continue their treatment with acenocoumarol. After a transition period of 1 month, patients will be followed up for 6 months and TTR and secondary end points will be assesse
J.S. Biederman
Postbus 5201, 3008 AE Rotterdam
Rotterdam 3015 CN
The Netherlands
030 733 73 45
j.biedermann@erasmusmc.nl
J.S. Biederman
Postbus 5201, 3008 AE Rotterdam
Rotterdam 3015 CN
The Netherlands
030 733 73 45
j.biedermann@erasmusmc.nl
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
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
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 | NL5023 |
| NTR-old | NTR5169 |
| Other | EUDRACT : 2015-001757-33 |