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

Phase 1

• Conditions: Patients with Non-Valvular Atrial Fibrillation with at least one risk factor for stroke and indicated for oral anticoagulant.; MedDRA version: 16.0Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000055-41-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-06-26
• Study Completion: 2016-01-20
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1217

Inclusion Criteria

- Signed Written Informed Consent.

- Patients with diagnosed non-valvular AF (documented by 12-lead ECG or Holter recording) and eligible for OAC therapy.

- Presence of at least one of the following risk factors for stroke:
prior stroke or transient ischaemic attack (TIA)
age ?75 years
hypertension
diabetes mellitus
symptomatic heart failure (NYHA Class ? II)

- Must be able to self-administer treatment.

- Either VKA treated or VKA naive. Patients treated with VKA should have received the VKA treatment for ? 6 months. VKA naïve patients should 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 (and will switch to Apixaban).

- Subject Re-enrollment: This study does not permit the re-enrollment of a subject that has discontinued the study as a pre-treatment failure.

- Men and women ? 18 years of age.

- Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in Appendix 4.

- WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication.

- Women must not be breastfeeding.

- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year.

- Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile; see Section 3.3.3 for the definition of WOCBP) and azoospermic men do not require contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 333
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 779

Exclusion Criteria

1) Target Disease Exceptions
a) Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
b) Clinically significant (moderate or severe) mitral stenosis
c) Cardiac valvular disease requiring surgery
d) Planned atrial fibrillation ablation procedure to be performed during study period.
2) Medical History and Concurrent Diseases
a) Conditions other than atrial fibrillation that require chronic anticoagulation (e.g., prosthetic mechanical heart valve, venous thromboembolism; also see Section 3.4, Concomitant Treatments).
b) Patient with serious bleeding in the last 6 months or with a lesion or condition at high risk
of bleeding such as:
? Active peptic ulcer disease, current or recent gastrointestinal ulceration
?Known or suspected oesophageal varices
?Recent ischemic stroke (within 7 days)
?Recent brain or spinal injury or intracranial haemorrhage
?Recent brain, spinal or ophthalmic surgery
?Arteriovenous malformations,
?Vascular aneurysms
?Major intraspinal or intracerebral vascular abnormalities
?Documented hemorrhagic tendencies or blood dyscrasias
?Presence of malignant neoplasms at high risk of bleeding
c) Persistent, uncontrolled hypertension (systolic BP > 180 mm Hg, and/or diastolic BP > 100 mm Hg)
d) Active infective endocarditis
e) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
f) Active alcohol or drug abuse, or psychosocial reasons that make study participation impractical.
g) Severe co-morbid condition with life expectancy ?1 year
3) Physical and Laboratory Test Findings
a) Severe renal insufficiency (creatinine clearance must be calculated in all patients; any patient with a calculated creatinine clearance <15 ml/min is excluded) or patients undergoing dialysis.
b) ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 2 times upper limit of normal or a total bilirubin > 1.5 times upper limit of normal (unless an alternative causative factor [e.g., Gilbert?s syndrome] is identified)
c) Haemoglobin < 9 g/dL
d) Platelet count < 100,000/mm3
4) Allergies and Adverse Drug Reaction
a) Allergy or adverse reaction to apixaban or any of the excipients
5) Sex and Reproductive Status
a) Women who are pregnant or breast feeding
b) Women of child bearing potential (WOCBP, see Section 3.3.3 for definition) who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy.
c) Sexually active fertile men not willing to use effective birth control if their partners are WOCBP
6) Prohibited Treatments and/or Therapies
a) See Section 3.4.1 (Prohibited and/or Restricted Treatments) for therapies which are
prohibited at study entry
b) Required treatment with ASA > 165 mg/day
c) Simultaneous treatment with a thienopyridine (e.g., clopidogrel, ticlopidine; see Section 3.4.2.1, Acetylsalicylic acid [ASA] and Thienopyridines) or prasugrel or ticagrelor
d) Planned major surgery or/and invasive procedure
e) Planned atrial fibrillation or flutter ablation procedure
7) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
c) Use of an unapproved, investigational drug or device within the past 30 days or prior participation into an apixaban clinical study
d) Inability to comply with protocol visit and activity requirements
e) Subjects unable

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the impact of educational programme on implementation phase adherence in patients taking apixaban for SPAF at 24 weeks.;Secondary Objective: - To identify predictive risk factors linked to non-adherence in patients treated with apixaban.<br>- To compare implementation phase adherence to apixaban treatment with secondary standard of care (SOC) versus (1) primary standard of care (SOC) and (2) continued additional educational program.<br>- To compare implementation phase adherence to apixaban treatment at 12 weeks vs 24 weeks within groups.<br>- To evaluate impact of educational programme on safety profile of apixaban.;Primary end point(s): The primary endpoint for this study is 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: Standard Of Care (SOC) information or additional education.;Timepoint(s) of evaluation of this end point: At 24 weeks

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: At 12, 24 and 48 weeks;Secondary end point(s): - 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.<br>- Adherence to apixaban dosing regimen during the 24 to 48 weeks in continued additional education group, secondary SOC group, and primary SOC group.<br>- Risk factors indicative of non-adherence at 24 and 48 weeks.<br>- Serious adverse events and other AEs, including major bleeding (ISTH)