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

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

Overview[ - collapse ][ - ]

Purpose	The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks
Condition	Non-valvular Atrial Fibrillation
Intervention	Drug: Apixaban
Phase	Phase 4
Sponsor	Bristol-Myers Squibb
Responsible Party	Bristol-Myers Squibb
ClinicalTrials.gov Identifier	NCT01884350
First Received	June 13, 2013
Last Updated	December 16, 2013
Last verified	December 2013

Tracking Information[ + expand ][ + ]

First Received Date	June 13, 2013
Last Updated Date	December 16, 2013
Start Date	November 2013
Estimated Primary Completion Date	September 2015
Current Primary Outcome Measures	Percentage of days with a correct execution of the Apixaban dosing regimen during 24 weeks [Time Frame: Up to week 24] [Designated as safety issue: No]This endpoint will be compared between the two study groups: Standard of care (SOC) information or additional education
Current Secondary Outcome Measures	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 [Time Frame: Up to week 24] [Designated as safety issue: No] Adherence to Apixaban dosing regimen during the 24 to 48 weeks in continued additional education group, secondary SOC group, and primary SOC group [Time Frame: Up to week 48] [Designated as safety issue: No] Risk factors indicative of non-adherence at 24 and 48 weeks [Time Frame: Up to Week 48] [Designated as safety issue: No]Within each group, a linear regression approach will be used to identify predictors of non-adherence within baseline characteristics. Possible predictors include Mini-Mental State Examination (MMSE) scores, age, number of concomitant medications, ethnicity, United Kingdom (UK) standard occupational classification, and previous experience with vitamin K antagonists [VKA] (Yes versus No) Incidence of serious adverse events (AEs) and other AEs, including major bleeding (ISTH) [Time Frame: Up to week 48] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	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)
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
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Condition	Non-valvular Atrial Fibrillation
Intervention	Drug: Apixaban Other Names: Eliquis BMS-562247
Study Arm (s)	Experimental: Arm 1: Apixaban (Primary SOC information) Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Primary SOC information Experimental: Arm 2: Apixaban (Additional Educational Program) Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Additional Educational Program

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	1112
Estimated Completion Date	September 2015
Estimated Primary Completion Date	July 2014
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
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Contact: For Site information please email: Clinical.Trials@bms.com
Location Countries	France

Administrative Information[ + expand ][ + ]

NCT Number	NCT01884350
Other Study ID Numbers	CV185-220
Has Data Monitoring Committee	No
Information Provided By	Bristol-Myers Squibb
Study Sponsor	Bristol-Myers Squibb
Collaborators	Not Provided
Investigators	Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Verification Date	December 2013

Locations[ + expand ][ + ]

Local Institution	Saint Etienne, Cedex 2, France, 42055 Contact: Site 0019 Recruiting
Local Institution	Abbeville, France, 80142 Contact: Site 0013 Recruiting
Local Institution	Avignon, France, 84000 Contact: Site 0016 Recruiting
Local Institution	Bayonne Cedex, France, 64109 Contact: Site 0014 Recruiting
Local Institution	Boulogne-billancourt, France, 92100 Contact: Site 0023 Recruiting
Local Institution	Cannes, France, 06400 Contact: Site 0011 Recruiting
Local Institution	Clermont Ferrand, France, 63003 Contact: Site 0021 Recruiting
Local Institution	Dijon Cedex, France, 21079 Contact: Site 0015 Recruiting
Local Institution	La Rochelle Cedex, France, 17019 Contact: Site 0009 Recruiting
Local Institution	Orleans Cedex 2, France, 45067 Contact: Site 0010 Recruiting
Local Institution	Paris, France, 75908 Contact: Site 0020 Recruiting
Local Institution	Paris, France, 75015 Contact: Site 0022 Recruiting
Local Institution	Paris Cedex 14, France, 75674 Contact: Site 0012 Recruiting
Local Institution	Pau Universite Cedex, France, 64046 Contact: Site 0017 Recruiting
Local Institution	Salouel, France, 80480 Contact: Site 0018 Recruiting