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More precise dosing of acenocoumarol in patients aged 80 and above, a pilot study

More precise dosing of acenocoumarol in patients aged 80 and above, a pilot study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON25342
Enrollment
80
Registered
2016-09-22
Start date
2017-10-30
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial fibrillation, venous thrombo-embolism, heart valve repair Boezemfibrilleren, trombose, longembolie, hartklepvervanging

Interventions

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

Sponsors

University Medical Center Groningen
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
The main study parameter is quality of anticoagulation (individual time in therapeutic range and INR variability).

Secondary

MeasureTime frame
The secondary study parameters are treatment satisfaction, medication errors and number of INR measurements.

Contacts

Public ContactJasper (J.H.A.) van Miert

UMCG

j.h.a.van.miert@umcg.nl+31503610225

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)