No registrations found.
ID
Source
Brief title
Health condition
Atrial fibrillation, venous thrombo-embolism, heart valve repair
Boezemfibrilleren, trombose, longembolie, hartklepvervanging
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
The secondary study parameters are treatment satisfaction, medication errors and number of INR measurements.
Background summary
More precise dosing of acenocoumarol in patients aged 80
and above, a pilot study
Study objective
We hypothesise that dosing using tablets of half a milligram acenocoumarol increases anticoagulation control
Study design
Start of study, six months later
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.
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
- Using acenocoumarol for any indication, and being 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 nine months
- Expected termination of VKA within six months
- Dosing step lower than or equal to "step 7", i.e. usage of less than 3.5 milligrams acenocoumarol per week. Patients who use such a low dose generally have an unfavourable prognosis.
- Patients who determine the acenocoumarol dose themselves
Design
Recruitment
IPD sharing statement
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 | NL5905 |
| NTR-old | NTR6093 |
| Other | UMCG Research Registry : 2016 006 20 |