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

NCT01884350 | Completed Phase 4 Results

• 2 other identifiers: CV185-2202013-000055-41
• Study Type: interventional
• Target: 1,217
• Locations: 7 countries
• Sites: 220

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

Conditions

Non-valvular Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen

  The mean percentage of days which participants maintained adherence to apixaban treatment was measured for each arm. Adherence to apixaban = number of units of adherence \*100 / total number of eligible days for the time period from first dose date, up to 169 days. Unit of adherence: A 24-hour window where the treatment is taken as prescribed, ie, 1 tablet (5 mg or 2.5 mg, as appropriate) 2 times a day. If only one dose is missed in 24-hours, it is still considered as a unit of adherence. Adherence up to 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 24 weeks, the denominator time period was censored at the earlier of last dose date or discontinuation date for discontinuation due to reasons unrelated to participant adherence, such as withdrawn consent, or AE; otherwise, the period was censored at the minimum of 169 days and last dose date + 30 days.

  Day 1 up to week 24

Secondary Outcomes (5)

• 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

  Day 1 to Week 12, Week 12 to Week 24

• Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period

  Week 24 to Week 48

• Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks

  Week 24

• Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death

  Day 1 up to week 24

• Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death

  Week 24 up to Week 48

Study Arms (2)

Arm 1: Apixaban (Primary SOC information)

EXPERIMENTAL

Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Primary Standard of Care (SOC) information

Drug: Apixaban

Arm 2: Apixaban (Additional Educational Program)

EXPERIMENTAL

Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Additional Educational Program

Drug: Apixaban

Interventions

Apixaban DRUG

Also known as: Eliquis, BMS-562247

Arm 1: Apixaban (Primary SOC information); Arm 2: Apixaban (Additional Educational Program)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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 \[New York Heart Association (NYHA) Class ≥II\]
• Must be able to self-administer treatment
• 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
• Patients previously treated with acetylsalicylic acid (ASA) for stroke prevention are allowed (and will switch to Apixaban)
• Patients with screening mini-mental state examination (MMSE) more than 24
• 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

You may not qualify if:

• Target Disease Exceptions:
• Atrial fibrillation or flutter due to reversible causes (e.g. thyrotoxicosis, pericarditis)
• Clinically significant (moderate or severe) mitral stenosis
• Cardiac valvular disease requiring surgery
• Planned major surgery or/and invasive procedure and/or atrial fibrillation or flutter, ablation procedure and/or cardioversion
• Patients receiving Rivaroxaban, Dabigatran or Apixaban
• Medical History and Concurrent Diseases:
• Conditions other than atrial fibrillation that require chronic anticoagulation (e.g., prosthetic mechanical heart valve, venous thromboembolism; also see Section 3.4, Concomitant Treatments)
• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (220)

Local Institution

Antwerp, 2060, Belgium

Location

Local Institution

Arlon, 6700, Belgium

Location

Local Institution

Bonheiden, 2820, Belgium

Location

Local Institution

Braine-l'Alleud, 1420, Belgium

Location

Local Institution

Brussels, 1020, Belgium

Location

Local Institution

Brussels, 1090, Belgium

Location

Local Institution

Ghent, 9000, Belgium

Location

Local Institution

Gilly, 6060, Belgium

Location

Local Institution

Hasselt, 3500, Belgium

Location

Local Institution

Leuven, 3000, Belgium

Location

Local Institution

Liège, 4000, Belgium

Location

Local Institution

Ronse, 9600, Belgium

Location

Local Institution

Woluwe-Saint-Lambert, 1200, Belgium

Location

Local Institution

Yvoir, 5530, Belgium

Location

Local Institution

Yvoir, B-5530, Belgium

Location

Local Institution

Saint-Etienne, Cedex 2, 42055, France

Location

Local Institution

Abbeville, 80142, France

Location

Local Institution

Aix-en-Provence, 13616, France

Location

Local Institution

Avignon, 84000, France

Location

Local Institution

Avignon, 84902, France

Location

Local Institution

Bayonne, 64100, France

Location

Local Institution

Bayonne, 64109, France

Location

Local Institution

Béziers, 34525, France

Location

Local Institution

Bobigny, 93009, France

Location

Local Institution

Bordeaux, 33000, France

Location

Local Institution

Bordeaux, 33075, France

Location

Local Institution

Boulogne-Billancourt, 92100, France

Location

Local Institution

Brest, 29609, France

Location

Local Institution

Bron, 69677, France

Location

Local Institution

Caen, 14000, France

Location

Local Institution

Cambrai, 59407, France

Location

Local Institution

Cannes, 06400, France

Location

Local Institution

Chambray-lès-Tours, 37044, France

Location

Local Institution

Chartes, 28108, France

Location

Local Institution

Châtellerault, 86106, France

Location

Local Institution

Cholet, 49309, France

Location

Local Institution

Clermont-Ferrand, 63003, France

Location

Local Institution

Colombes, 92701, France

Location

Local Institution

Corbeil-Essonnes, 91106, France

Location

Local Institution

Créteil, 94010, France

Location

Local Institution

Dijon, 21079, France

Location

Local Institution

Grenoble, 38043, France

Location

Local Institution

Haguenau, 67502, France

Location

Local Institution

La Rochelle, 17019, France

Location

Local Institution

Le Chesnay, 78150, France

Location

Local Institution

Lille, 59000, France

Location

Local Institution

Lille, 59037, France

Location

Local Institution

Longjumeau, 91164, France

Location

Local Institution

Marseille, 13003, France

Location

Local Institution

Marseille, 13008, France

Location

Local Institution

Marseille, 13385, France

Location

Local Institution

Marseille, 13915, France

Location

Local Institution

Montfermeil, 93370, France

Location

Local Institution

Montpellier, 34000, France

Location

Local Institution

Montpellier, 34295, France

Location

Local Institution

Nantes, 44277, France

Location

Local Institution

Neuilly-sur-Seine, 92523, France

Location

Local Institution

Nice, 06105, France

Location

Local Institution

Nîmes, 30029, France

Location

Local Institution

Orléans, 45067, France

Location

Local Institution

Paris, 75010, France

Location

Local Institution

Paris, 75013, France

Location

Local Institution

Paris, 75015, France

Location

Local Institution

Paris, 75674, France

Location

Local Institution

Paris, 75908, France

Location

Local Institution

Pau Universite Cedex, 64046, France

Location

Local Institution

Pessac, 33604, France

Location

Local Institution

Plan-de-Cuques, 13380, France

Location

Local Institution

Rennes, 35033, France

Location

Local Institution

Saint-Benoît, 86280, France

Location

Local Institution

Saint-Denis, 93207, France

Location

Local Institution

Salouël, 80480, France

Location

Local Institution

Sète, 34200, France

Location

Local Institution

Strasbourg, 67000, France

Location

Local Institution

Strasbourg, 67090, France

Location

Local Institution

Thionville, 57100, France

Location

Local Institution

Thonon-les-Bains, 74203, France

Location

Local Institution

Toulouse, 31054, France

Location

Local Institution

Toulouse, 31076, France

Location

Local Institution

Tourcoing, 59208, France

Location

Local Institution

Valence, 26000, France

Location

Local Institution

Valenciennes, 59322, France

Location

Local Institution

Vesoul, 70014, France

Location

Local Institution

Wardenburg, 26203, France

Location

Local Institution

Spaichingen, Baden-wurttembe, 78549, Germany

Location

Local Institution

Krombach, Bavaria, 63829, Germany

Location

Local Institution

Augsburg, 86159, Germany

Location

Local Institution

Aurich, 26603, Germany

Location

Local Institution

Bad Homburg, 61348, Germany

Location

Local Institution

Balingen, 72336, Germany

Location

Local Institution

Bamberg, Germany

Location

Local Institution

Berin, 10559, Germany

Location

Local Institution

Berlin, 10367, Germany

Location

Local Institution

Berlin, 10789, Germany

Location

Local Institution

Berlin, 12351, Germany

Location

Local Institution

Berlin, 12524, Germany

Location

Local Institution

Berlin, 13405, Germany

Location

Local Institution

Chemnitz, 09122, Germany

Location

Local Institution

Deggingen, 73326, Germany

Location

Local Institution

Dillingen, 66763, Germany

Location

Local Institution

Dresden, 01099, Germany

Location

Local Institution

Dresden, 01277, Germany

Location

Local Institution

Erfurt, 99084, Germany

Location

Local Institution

Essen, 45138, Germany

Location

Local Institution

Flörsheim, 65439, Germany

Location

Local Institution

Friedberg, Germany

Location

Local Institution

Gars/Inn, 83536, Germany

Location

Local Institution

Göttingen, 37073, Germany

Location

Local Institution

Grossheirath Rossbach, 96269, Germany

Location

Local Institution

Hamburg, 22299, Germany

Location

Local Institution

Hamburg, 22459, Germany

Location

Local Institution

Haßloch, 67454, Germany

Location

Local Institution

Heidelberg, 69115, Germany

Location

Local Institution

Heidenau, 01809, Germany

Location

Local Institution

Kassel, 34117, Germany

Location

Local Institution

Kelkheim, 65779, Germany

Location

Local Institution

Künzing, 94550, Germany

Location

Local Institution

Langestrasse, 04910, Germany

Location

Local Institution

Leipzig, 04104, Germany

Location

Local Institution

Lollar, 35457, Germany

Location

Local Institution

Ludwigsburg, 71634, Germany

Location

Local Institution

Ludwigsburg, 71640, Germany

Location

Local Institution

Mammendorf, 82291, Germany

Location

Local Institution

Mannheim, 68161, Germany

Location

Local Institution

Mannheim, 68163, Germany

Location

Local Institution

Markkleeberg, 04416, Germany

Location

Local Institution

Münster, 48149, Germany

Location

Local Institution

Myen, 56727, Germany

Location

Local Institution

Neukirchen, 66539, Germany

Location

Local Institution

Neunirchen, 66540, Germany

Location

Local Institution

Northeim, 37154, Germany

Location

Local Institution

Obermichelbach, Germany

Location

Local Institution

Papenburg, D-26871, Germany

Location

Local Institution

Pirna, 01796, Germany

Location

Local Institution

Riesa, D-01587, Germany

Location

Local Institution

Rodgau, 63110, Germany

Location

Local Institution

Rotenburg /fulda, 36199, Germany

Location

Local Institution

Sinzheim, 76547, Germany

Location

Local Institution

Stockach, 78333, Germany

Location

Local Institution

Unterschneidheim, 73485, Germany

Location

Local Institution

Wallerfing, 94574, Germany

Location

Local Institution

Wangen, 88239, Germany

Location

Local Institution

Weißenhorn, 89264, Germany

Location

Local Institution

Wermsdorf, 04779, Germany

Location

Local Institution

Wetzlar, 35584, Germany

Location

Local Institution

Weyhe, 28844, Germany

Location

Local Institution

Winsen, 21423, Germany

Location

Local Institution

Milan, MI, 20122, Italy

Location

Local Institution

Arezzo, 52100, Italy

Location

Local Institution

Bologna, 40133, Italy

Location

Local Institution

Castelfranco Veneto (tv), 31033, Italy

Location

Local Institution

Catanzaro, 88100, Italy

Location

Local Institution

Cremona, 26100, Italy

Location

Local Institution

Florence, 50122, Italy

Location

Local Institution

Florence, 50134, Italy

Location

Local Institution

Foggia, 71100, Italy

Location

Local Institution

L’Aquila, 67100, Italy

Location

Local Institution

Mestre, 30174, Italy

Location

Local Institution

Milan, 20132, Italy

Location

Local Institution

Milan, 20142, Italy

Location

Local Institution

Naples, 80123, Italy

Location

Local Institution

Napoli, 80131, Italy

Location

Local Institution

Palermo, 90127, Italy

Location

Local Institution

Pavia, 27100, Italy

Location

Local Institution

Perugia, 06132, Italy

Location

Local Institution

Piacenza, 29100, Italy

Location

Local Institution

Reggio Emilia, 42100, Italy

Location

Local Institution

Roma, 00128, Italy

Location

Local Institution

Roma, 00135, Italy

Location

Local Institution

Roma, 00161, Italy

Location

Local Institution

San Daniele Del Friuli(udine), 33038, Italy

Location

Local Institution

Siena, 53100, Italy

Location

Local Institution

Torino, 10126, Italy

Location

Local Institution

Treviso, 31100, Italy

Location

Local Institution

Varese, 21100, Italy

Location

Local Institution

Vicenza, 36100, Italy

Location

Local Institution

Vimercate, 20059, Italy

Location

Local Institution

Viterbo, 01100, Italy

Location

Local Institution

San Sebastián de los Reyes, Madrid, 28702, Spain

Location

Local Institution

Aldaia, 46960, Spain

Location

Local Institution

Alicante, 03015, Spain

Location

Local Institution

Barcelona, 08013, Spain

Location

Local Institution

Barcelona, 08025, Spain

Location

Local Institution

Barcelona, 08036, Spain

Location

Local Institution

Galdakao, 48960, Spain

Location

Local Institution

Madrid, 28009, Spain

Location

Local Institution

Madrid, 28033, Spain

Location

Local Institution

Madrid, 28046, Spain

Location

Local Institution

Murcia, 30120 El Palmar, Spain

Location

Local Institution

Oviedo, 33006, Spain

Location

Local Institution

Santiago de Compostela, 15706, Spain

Location

Local Institution

Tarragona, 43007, Spain

Location

Local Institution

Valencia, 46010, Spain

Location

Local Institution

Valencia, 46026, Spain

Location

Local Institution

Viladecans, 08840, Spain

Location

Local Institution

Zaragoza, 50009, Spain

Location

Local Institution

Lugano, Canton Ticino, 6900, Switzerland

Location

Local Institution

Fribourg, Canton, 1708, Switzerland

Location

Local Institution

Baden, 5404, Switzerland

Location

Local Institution

Bern, 3004, Switzerland

Location

Local Institution

Winterthur, 8401, Switzerland

Location

Local Institution

Zurich, 8032, Switzerland

Location

Local Institution

Zurich, 8063, Switzerland

Location

Local Institution

Craigavon, Armagh, BT63 5QQ, United Kingdom

Location

Local Institution

Darlington, County Durham, DL3 8SQ, United Kingdom

Location

Local Institution

Exeter, Devon, EX2 5DW, United Kingdom

Location

Local Institution

Bournemouth, Dorset, BH7 7DW, United Kingdom

Location

Local Institution

Poole, Dorset, BH15 2JB, United Kingdom

Location

Local Institution

Westcliff-on-Sea, Essex, SS0 0RT, United Kingdom

Location

Local Institution

Ashford, KENT, TN24 0LZ, United Kingdom

Location

Local Institution

Glasgow, Lanarkshire, G75 8RG, United Kingdom

Location

Local Institution

Airdrie, Lancashire, ML6 OJS, United Kingdom

Location

Local Institution

Liverpool, Merseyside, L7 8XP, United Kingdom

Location

Local Institution

Stoke-on-Trent, Staffordshire, ST4 6QG, United Kingdom

Location

Local Institution

Birmingham, WEST Midlands, B18 7QH, United Kingdom

Location

Local Institution

Dudley, WEST Midlands, DY1 2HQ, United Kingdom

Location

Local Institution

Hereford, HR12ER, United Kingdom

Location

Local Institution

Oldham, OL12JH, United Kingdom

Location

Local Institution

Somerset, BA21 4AT, United Kingdom

Location

Local Institution

Tauton, TA1 5DA, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 31243691 DERIVED

Related Links

• BMS Clinical Trial Information
• BMS Clinical Trial Patient Recruiting
• Investigator Inquiry Form
• FDA Safety Alerts and Recalls

MeSH Terms

Interventions

apixaban

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

Clinical.Trials@bms.com

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 24, 2013
• Study Start: October 15, 2013
• Primary Completion: January 20, 2016
• Study Completion: January 20, 2016
• Last Updated: August 19, 2019
• Results First Posted: August 19, 2019

Record last verified: 2019-07

Locations

IT (31); ES (18); CH (7); DE (63); GB (17); BE (15); FR (69)