"stroke prevention in Atrial Fibrillation " "stroke prevention in cardiac arrhythmia"
Conditions
Interventions
First 24 weeks:
-group 1 will receive standard information (SOC)
-group 2 will receive additional education programme
Second 24 weeks:
-group 1 will receive standard information (SOC) again
-50% of g
Sponsors
Bristol-Myers Squibb
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: -Signed written informed consent -Patients (from18 years old) with diagnosed non-valvular AF and eligible for OAC therapy -Presence of at least one of the following risk factors for stroke: prior stroke or TIA, Age >74, hypertension, diabetes mellitus, symptomatic heart failure -must be able to self-administer treatment -Either VKA treated or VKA naive. VKA-treated patients must have received the VKA treatment for more than 3 months. VKA-naive patients must not have received VKA treatment for more than 30 days within the last 12 months. -Patients previously treated with ASA for stroke prevention are allowed -Patients with screening Mini-mental state examination score (MMSE) more than 24 (out of 30). -Acceptable method of contraception/negative pregnancy test
Exclusion criteria
Exclusion criteria: -Atrial fibrillation or flutter due to reversible causes -Clinically significant mitral stenosis -Cardiac valvular disease requiring surgery -Conditions other than AF that require chronic anticoalgulation (see also section 3.4. of the Protocol) -Patients with serious bleeding in the last 6 months or with lesion or high risk of bleeding -Persistent, uncontrolled hypertension -Active infective endocarditis -Hepatic disease associated with coagulopathy and clinically relevant bleeding risk -Active alcohol or drug abuse or psychological reason that makes the study participation impractical -Severe co-morbid condition with life expectancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: The percentage of days with a correct execution of the apixaban dosing regimen during 24 weeks. This endpoint will be compared between the two study groups: SOC information or additional education. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: -Within each study group, percentage of days with a correct execution of the apixaban dosing regimen during the 12 to 24 weeks period compared with during the first 12 weeks. -Adherence to apixaban dosing regimen during the 24 to 48 weeks in continued additional education group, secondary SOC group and primary SOC group. -Risk factors indicative of non-adherence at 24 and 48 weeks -Serious Adverse Events and other AE's, including major bleeding (ISTH) | — |
Countries
Netherlands
Outcome results
None listed