Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation.

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 40

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

-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 < 1 year
-Severe renal insuffiency calculated by Cockrof-Gault or undergoing dialysis
-Allergy or adverse reaction to Apixaban
-Women who are pregnant or breast feeding
- Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling / unable to use acceptable method to avoid pregnancy (as per section 3.3.3. of the Protocol)
-Other:
as per section 3.3.2. 6) and 7)
Prohibited and/or restricted treatments as per section 3.4.1. of the protocol

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint:<br /><br>The percentage of days with a correct execution of the apixaban dosing regimen<br /><br>during 24 weeks. This endpoint will be compared between the two study groups:<br /><br>SOC information or additional education.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary endpoints:<br /><br>-Within each study group, percentage of days with a correct execution of the<br /><br>apixaban dosing regimen during the 12 to 24 weeks period compared with during<br /><br>the first 12 weeks.<br /><br>-Adherence to apixaban dosing regimen during the 24 to 48 weeks in continued<br /><br>additional education group, secondary SOC group and primary SOC group.<br /><br>-Risk factors indicative of non-adherence at 24 and 48 weeks<br /><br>-Serious Adverse Events and other AE's, including major bleeding (ISTH)</p><br>