The main objective is to collect data on effect size for, and determine the feasibility of, a full scale RCT to assess the effect of dosing per 0.5 mg acenocoumarol on quality of anticoagulation, treatment satisfaction, and medication errors.
ID
Source
Brief title
Condition
- Coagulopathies and bleeding diatheses (excl thrombocytopenic)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is quality of anticoagulation (individual time in
therapeutic range and INR variability).
Secondary outcome
Treatment satisfaction and number of medication errors.
Background summary
40% of patients using anticoagulants is eighty years or older. In this
vulnerable age group there is a delicate balance between haemorrhages and
thrombosis. Good quality of anticoagulation is of paramount importance, but
this is less frequently achieved with higher age. Decreasing acenocoumarol
dosage may cause a higher variability.
We hypothesise that dosing using tablets of half a milligram acenocoumarol
increases anticoagulation control.
Study objective
The main objective is to collect data on effect size for, and determine the
feasibility of, a full scale RCT to assess the effect of dosing per 0.5 mg
acenocoumarol on quality of anticoagulation, treatment satisfaction, and
medication errors.
Study design
Randomised controlled trial, with 2 treatment groups (see below) with 40
patients each.
Intervention
One group is dosed using tablets of 0.5 milligrams of acenocoumarol, while the
other group uses the regular 1.0 milligram tablets. Both will be dose-adjusted
to their previously determined INR target range.
Study burden and risks
Patients already use dose-adjusted acenocoumarol, so we do not expect an added
risk caused by the drug. All patients will be visited and administered a short
questionnaire twice for the study. The intervention group will on average have
to take twice as many tablets of acenocoumarol as before. This research will
yield data relevant for the participating patients and other, similar patients.
Hanzeplein 1
Groningen 9713GZ
NL
Hanzeplein 1
Groningen 9713GZ
NL
Listed location countries
Age
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:;- Men or women who use acenocoumarol for any indication, who are managed by Certe Trombosedienst
- 80 years of age or older at time of inclusion
- Using acenocoumarol with an average daily dose of less than 2 milligrams in the previous three months
- Subject provided informed consent
Exclusion criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:;- Initiated therapy with acenocoumarol in the last three months
- Expected termination of VKA within six months
- Dosing step lower than or equal to "step 7", i.e. usage of less than 7 milligrams acenocoumarol per 2 weeks
- Patients who determine the acenocoumarol dose themselves
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2016-003086-25-NL |
| CCMO | NL58727.042.16 |