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…
ID
Bron
Verkorte titel
Aandoening
anticoagulation
Vitamin K antagonists
Point-of-care
Time in therapeutic range
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Percentage of time in therapeutic range at study end
Doel van het onderzoek
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
Onderzoeksopzet
baseline and study end (7 months after study start)
Onderzoeksproduct en/of interventie
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
Publiek
J.S. Biederman
Postbus 5201, 3008 AE Rotterdam
Rotterdam 3015 CN
The Netherlands
030 733 73 45
j.biedermann@erasmusmc.nl
Wetenschappelijk
J.S. Biederman
Postbus 5201, 3008 AE Rotterdam
Rotterdam 3015 CN
The Netherlands
030 733 73 45
j.biedermann@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL5023 |
| NTR-old | NTR5169 |
| Ander register | EUDRACT : 2015-001757-33 |