Primary:-To assess the impact of educational programme on implementation phase adherence in patients taking apixaban for Stroke Prevention in Non-Valvular Atrial Fibrillation (SPAF) at 24 weeks.Secondary:-To identify predictive risk factors linked…
ID
Source
Brief title
Condition
- Cardiac arrhythmias
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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)
Background summary
Adherence to OAC therapy can be challenging because of several reasons specific
to management of SPAF. Importance of rigorous patient education have been
recognized. , Specifically for FXa inhibitors such as apixaban, since these
treatments do not require routine efficacy monitoring, a key advantage over
warfarin, there is a perception amongst some HCPs that long term adherence for
apixaban may not be as good as warfarin, the current standard of care. Although
FXa inhibitors are superior in efficacy and safety to warfarin, some HCPs may
prefer warfarin over an FXa inhibitor because warfarin requires routine
monitoring and supervision, thus potentially ensuring greater adherence. The
key aim of this clinical study is to investigate the medium term implementation
phase adherence (adherence during the implementation phase) of apixaban with
education programme on initiation, and whether these additional educational and
reminder tools will enhance adherence through innovative technology.
This Phase 4 post marketing authorisation study aims for following:
1. Ensure appropriate usage of apixaban
2. Evaluate value of educational programme
3. Provide information regarding how to improve apixaban adherence for the
benefit of patients
4.Support HCP objective of improving patient education
Research Hypothesis:
1. Patients treated with apixaban have a good implementation phase adherence to
treatment with standard of care (SOC) patient information on disease and
treatment.
2. Implementation phase adherence can be enhanced by additional educational
tools, such as educational package, dosing reminders, and virtual clinics.
3. Given the chronic nature of apixaban treatment for stroke prevention in
atrial fibrillation (SPAF), persistence of implementation phase adherence to
the treatment will improve with adherence tools.
4.Additional educational programme for 24 additional weeks beyond the initial
24 weeks will enhance adherence.
Study objective
Primary:
-To assess the impact of educational programme on implementation phase
adherence in patients taking apixaban for Stroke Prevention in Non-Valvular
Atrial Fibrillation (SPAF) at 24 weeks.
Secondary:
-To identify predictive risk factors linked to non-adherence in patients
treated with apixaban.
-To compare implementation phase adherence to apixaban treatment with secondary
SOC versus primary SOC and continued additional educational program.
-To compare implementation phase adherence to apixaban treatment at 12 weeks
versus 24 weeks within groups.
-To evaluate impact of educational programme on safety profile of apixaban.
Study design
Multinational, multicentre, randomized, open label clinical trial. Eligible
subjects will be randomized 1:1 to receive either SOC information or additional
education tools. After the initial 24-weeks primary endpoint period subjects in
the group receiving additional education programme will be randomized 1:1 to
continue receiving additional education programme or stop and revert to SOC.
Patient adherence will be measured using an electronic monitoring device.
Intervention
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 group 2 will stop with the additional education programme and will
receive standard information (SOC)
-the other 50% will continue with the additional education programme
Study burden and risks
The subjects are indicated for the treatment with apixaban. Apixaban is
registered in the EU for the use of Prevention of Stroke in Non-Valvular Atrial
Fibrillation, of which the side effects are described in the SmPC. The most
important side effect is bleeding. The intervention of this study is or
standard information or additional education programme without any expected
risks. It may enhance adherence in patients using apixaban, important for the
efficacy and safety of the medication as it is for longterm use.
Chaussée de la Hulpe 185
Bruxelles B-1170
BE
Chaussée de la Hulpe 185
Bruxelles B-1170
BE
Listed location countries
Age
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
Design
Recruitment
Medical products/devices used
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 |
|---|---|
| EudraCT | EUCTR2013-000055-41-NL |
| CCMO | NL45162.068.13 |