atrial fibrillation venous thrombo-embolism heart valve repair other diseases with an indication for anticoagulation with vitamin K antagonists
Conditions
Interventions
Product Name: acenocoumarol
Pharmaceutical Form: Tablet
INN or Proposed INN: ACENOCOUMAROL
CAS Number: 152-72-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 1-
Sponsors
University Medical Center Groningen
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 80
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 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 outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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.;Secondary Objective: Not applicable.;Primary end point(s): The main study endpoint is quality of anticoagulation, assessed using the following parameters: - Individual time in therapeutic range (iTTR) Calculated using the Rosendaal method - INR variability Calculated using the Variance Growth Rate and the SDTinr;Timepoint(s) of evaluation of this end point: Six months after start of allocated therapy, over the previous six months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary study parameters are treatment satisfaction, medication errors and number of INR measurements. Treatment satisfaction will be assessed using the PACT-Q2 questionnaire. Medication errors are routinely collected by the Thrombosis Service. These will be analysed on number and category of error. All dates of INR measurements are routinely collected by the Thrombosis Service, so we can easily calculate the number of INR measurements.;Timepoint(s) of evaluation of this end point: At baseline and six months later | — |
Countries
Netherlands
Contacts
Public ContactCerte Thrombosis Service
Certe Thrombosis Service
Outcome results
None listed