Clinical trial NCT01884350: Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
Official title: Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Non-valvular Atrial Fibrillation
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2013-06-24
Enrollment: 1217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks

Detailed description: SPAF=Stroke Prevention in Atrial Fibrillation

ISTH=International Society on Thrombosis and Hemostasis

Primary Purpose: Other: To measure adherence to the study medication using an electronic monitoring device over the first 24 weeks on study medication

Eligibility criteria: Inclusion Criteria:

1. Patients with diagnosed non-valvular Atrial Fibrillation (AF) or atrial flutter (documented by 12-lead electrocardiogram (ECG) or Holter recording) and eligible for oral anticoagulant (OAC) therapy
2. 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 \[New York Heart Association (NYHA) Class ≥II\]
3. Must be able to self-administer treatment
4. Either Vitamin K antagonists (VKA) treated or VKA naive. Patients treated with VKA should have received the VKA treatment for ≥3 months. VKA naïve patients should not have received VKA treatment for more than 30 days within the last 12 months. Patients who are not described by either of the above criteria are not eligible for the study
5. Patients previously treated with acetylsalicylic acid (ASA) for stroke prevention are allowed (and will switch to Apixaban)
6. Patients with screening mini-mental state examination (MMSE) more than 24
7. Subject Re-enrollment: This study does not permit the re-enrollment of a subject that has discontinued the study as a pre-treatment failure

Age and Reproductive Status:

* i) Men and women ≥18 years of age
* ii) Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in protocol. 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
* iv) Women must not be breastfeeding
* v) Men who are sexually active with women of childbearing potential (WOCBP) must use any contraceptive method with a failure rate of less than 1% per year
* vi) Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile); and azoospermic men do not require contraception

Exclusion Criteria:

1. Target Disease Exceptions:

   1. Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
   2. Clinically significant (moderate or severe) mitral stenosis
   3. Cardiac valvular disease requiring surgery
   4. Planned major surgery or/and invasive procedure and/or atrial fibrillation or flutter, ablation procedure and/or cardioversion
   5. Patients receiving Rivaroxaban, Dabigatran or Apixaban
2. Medical History and Concurrent Diseases:

   1. Conditions other than atrial fibrillation that require chronic anticoagulation (e.g., prosthetic mechanical heart valve, venous thromboembolism; also see Section 3.4, Concomitant Treatments)
   2. 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 esophageal varices
      * Recent ischemic stroke (within 7 days)
      * Recent brain or spinal injury or intracranial hemorrhage
      * 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

Primary outcomes:
measure: Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen
timeFrame: Day 1 up to week 24
Secondary outcomes:
measure: 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
timeFrame: Day 1 to Week 12, Week 12 to Week 24
measure: Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period
timeFrame: Week 24 to Week 48
measure: Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks
timeFrame: Week 24
measure: Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death
timeFrame: Day 1 up to week 24
measure: Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death
timeFrame: Week 24 up to Week 48
Other outcomes:
Locations:
city: Antwerpen
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facility: Local Institution
city: Arlon
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city: Bonheiden
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state: Baden-wurttembe
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state: Madrid
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city: Barcelona
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city: Madrid
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city: Madrid
country: Spain
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city: Madrid
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city: Oviedo
country: Spain
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city: Santiago De Compostela
country: Spain
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city: Tarragona
country: Spain
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city: Valencia
country: Spain
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city: Valencia
country: Spain
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city: Viladecans
country: Spain
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city: Zaragoza
country: Spain
facility: Local Institution
city: Fribourg
country: Switzerland
facility: Local Institution
state: Canton
city: Lugano
country: Switzerland
facility: Local Institution
state: Ticino
city: Baden
country: Switzerland
facility: Local Institution
city: Bern 4
country: Switzerland
facility: Local Institution
city: Winterthur
country: Switzerland
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
city: Zurich
country: Switzerland
facility: Local Institution
city: Craigavon
country: United Kingdom
facility: Local Institution
state: Armagh
city: Darlington
country: United Kingdom
facility: Local Institution
state: County Durham
city: Exeter
country: United Kingdom
facility: Local Institution
state: Devon
city: Bournemouth
country: United Kingdom
facility: Local Institution
state: Dorset
city: Poole
country: United Kingdom
facility: Local Institution
state: Dorset
city: Westcliff-on-sea
country: United Kingdom
facility: Local Institution
state: Essex
city: Ashford
country: United Kingdom
facility: Local Institution
state: Kent
city: Glasgow
country: United Kingdom
facility: Local Institution
state: Lanarkshire
city: Airdrie
country: United Kingdom
facility: Local Institution
state: Lancashire
city: Liverpool
country: United Kingdom
facility: Local Institution
state: Merseyside
city: Stoke-on-trent
country: United Kingdom
facility: Local Institution
state: Staffordshire
city: Birmingham
country: United Kingdom
facility: Local Institution
state: WEST Midlands
city: Dudley
country: United Kingdom
facility: Local Institution
state: WEST Midlands
city: Hereford
country: United Kingdom
facility: Local Institution
city: Oldham
country: United Kingdom
facility: Local Institution
city: Somerset
country: United Kingdom
facility: Local Institution
city: Tauton
country: United Kingdom
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Montalescot G, Brotons C, Cosyns B, Crijns HJ, D'Angelo A, Drouet L, Eberli F, Lane DA, Besse B, Chan A, Vicaut E, Darius H; AEGEAN Study Investigators. Educational Impact on Apixaban Adherence in Atrial Fibrillation (the AEGEAN STUDY): A Randomized Clinical Trial. Am J Cardiovasc Drugs. 2020 Feb;20(1):61-71. doi: 10.1007/s40256-019-00356-2.