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AzTrials

Non-valvular Atrial FibrillationPhase 4AEGEANNCT01884350

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

A Phase 4 study testing Apixaban in people with Non-valvular Atrial Fibrillation, run by Bristol-Myers Squibb at 220 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non-valvular Atrial Fibrillation
What is being tested?
Apixaban
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,217 participants
Where
220 sitesin 7 countries
Study dates
15 Oct 2013to 20 Jan 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 18Show fewer
  • 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
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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
  • Vascular aneurysms
  • Major intraspinal or intracerebral vascular abnormalities
  • Documented hemorrhagic tendencies or blood dyscrasias
  • Presence of malignant neoplasms at high risk of bleeding

Trial locations and contacts

220 sites in 7 countries.

220 sites in 7 countries

France69 sites

  • Local Institution

    Abbeville, 80142

  • Local Institution

    Aix-en-Provence, 13616

  • Local Institution

    Avignon, 84000

  • Local Institution

    Avignon, 84902

  • Local Institution

    Bayonne, 64100

  • Local Institution

    Bayonne, 64109

  • Local Institution

    Béziers, 34525

  • Local Institution

    Bobigny, 93009

  • Local Institution

    Bordeaux, 33000

  • Local Institution

    Bordeaux, 33075

  • Local Institution

    Boulogne-Billancourt, 92100

  • Local Institution

    Brest, 29609

  • Local Institution

    Bron, 69677

  • Local Institution

    Caen, 14000

  • Local Institution

    Cambrai, 59407

  • Local Institution

    Cannes, 06400

  • Local Institution

    Chambray-lès-Tours, 37044

  • Local Institution

    Chartes, 28108

  • Local Institution

    Châtellerault, 86106

  • Local Institution

    Cholet, 49309

  • Local Institution

    Clermont-Ferrand, 63003

  • Local Institution

    Colombes, 92701

  • Local Institution

    Corbeil-Essonnes, 91106

  • Local Institution

    Créteil, 94010

  • Local Institution

    Dijon, 21079

  • Local Institution

    Grenoble, 38043

  • Local Institution

    Haguenau, 67502

  • Local Institution

    La Rochelle, 17019

  • Local Institution

    Le Chesnay, 78150

  • Local Institution

    Lille, 59000

  • Local Institution

    Lille, 59037

  • Local Institution

    Longjumeau, 91164

  • Local Institution

    Marseille, 13003

  • Local Institution

    Marseille, 13008

  • Local Institution

    Marseille, 13385

  • Local Institution

    Marseille, 13915

  • Local Institution

    Montfermeil, 93370

  • Local Institution

    Montpellier, 34000

  • Local Institution

    Montpellier, 34295

  • Local Institution

    Nantes, 44277

  • Local Institution

    Neuilly-sur-Seine, 92523

  • Local Institution

    Nice, 06105

  • Local Institution

    Nîmes, 30029

  • Local Institution

    Orléans, 45067

  • Local Institution

    Paris, 75010

  • Local Institution

    Paris, 75013

  • Local Institution

    Paris, 75015

  • Local Institution

    Paris, 75674

  • Local Institution

    Paris, 75908

  • Local Institution

    Pau Universite Cedex, 64046

  • Local Institution

    Pessac, 33604

  • Local Institution

    Plan-de-Cuques, 13380

  • Local Institution

    Rennes, 35033

  • Local Institution

    Saint-Benoît, 86280

  • Local Institution

    Saint-Denis, 93207

  • Local Institution

    Saint-Etienne, Cedex 2, 42055

  • Local Institution

    Salouël, 80480

  • Local Institution

    Sète, 34200

  • Local Institution

    Strasbourg, 67000

  • Local Institution

    Strasbourg, 67090

  • Local Institution

    Thionville, 57100

  • Local Institution

    Thonon-les-Bains, 74203

  • Local Institution

    Toulouse, 31054

  • Local Institution

    Toulouse, 31076

  • Local Institution

    Tourcoing, 59208

  • Local Institution

    Valence, 26000

  • Local Institution

    Valenciennes, 59322

  • Local Institution

    Vesoul, 70014

  • Local Institution

    Wardenburg, 26203

Other trials in France

Germany63 sites

  • Local Institution

    Augsburg, 86159

  • Local Institution

    Aurich, 26603

  • Local Institution

    Bad Homburg, 61348

  • Local Institution

    Balingen, 72336

  • Local Institution

    Bamberg

  • Local Institution

    Berin, 10559

  • Local Institution

    Berlin, 10367

  • Local Institution

    Berlin, 10789

  • Local Institution

    Berlin, 12351

  • Local Institution

    Berlin, 12524

  • Local Institution

    Berlin, 13405

  • Local Institution

    Chemnitz, 09122

  • Local Institution

    Deggingen, 73326

  • Local Institution

    Dillingen, 66763

  • Local Institution

    Dresden, 01099

  • Local Institution

    Dresden, 01277

  • Local Institution

    Erfurt, 99084

  • Local Institution

    Essen, 45138

  • Local Institution

    Flörsheim, 65439

  • Local Institution

    Friedberg

  • Local Institution

    Gars/Inn, 83536

  • Local Institution

    Göttingen, 37073

  • Local Institution

    Grossheirath Rossbach, 96269

  • Local Institution

    Hamburg, 22299

  • Local Institution

    Hamburg, 22459

  • Local Institution

    Haßloch, 67454

  • Local Institution

    Heidelberg, 69115

  • Local Institution

    Heidenau, 01809

  • Local Institution

    Kassel, 34117

  • Local Institution

    Kelkheim, 65779

  • Local Institution

    Krombach, Bavaria, 63829

  • Local Institution

    Künzing, 94550

  • Local Institution

    Langestrasse, 04910

  • Local Institution

    Leipzig, 04104

  • Local Institution

    Lollar, 35457

  • Local Institution

    Ludwigsburg, 71634

  • Local Institution

    Ludwigsburg, 71640

  • Local Institution

    Mammendorf, 82291

  • Local Institution

    Mannheim, 68161

  • Local Institution

    Mannheim, 68163

  • Local Institution

    Markkleeberg, 04416

  • Local Institution

    Münster, 48149

  • Local Institution

    Myen, 56727

  • Local Institution

    Neukirchen, 66539

  • Local Institution

    Neunirchen, 66540

  • Local Institution

    Northeim, 37154

  • Local Institution

    Obermichelbach

  • Local Institution

    Papenburg, D-26871

  • Local Institution

    Pirna, 01796

  • Local Institution

    Riesa, D-01587

  • Local Institution

    Rodgau, 63110

  • Local Institution

    Rotenburg /fulda, 36199

  • Local Institution

    Sinzheim, 76547

  • Local Institution

    Spaichingen, Baden-wurttembe, 78549

  • Local Institution

    Stockach, 78333

  • Local Institution

    Unterschneidheim, 73485

  • Local Institution

    Wallerfing, 94574

  • Local Institution

    Wangen, 88239

  • Local Institution

    Weißenhorn, 89264

  • Local Institution

    Wermsdorf, 04779

  • Local Institution

    Wetzlar, 35584

  • Local Institution

    Weyhe, 28844

  • Local Institution

    Winsen, 21423

Other trials in Germany

Italy31 sites

  • Local Institution

    Arezzo, 52100

  • Local Institution

    Bologna, 40133

  • Local Institution

    Castelfranco Veneto (tv), 31033

  • Local Institution

    Catanzaro, 88100

  • Local Institution

    Cremona, 26100

  • Local Institution

    Florence, 50122

  • Local Institution

    Florence, 50134

  • Local Institution

    Foggia, 71100

  • Local Institution

    L’Aquila, 67100

  • Local Institution

    Mestre, 30174

  • Local Institution

    Milan, MI, 20122

  • Local Institution

    Milan, 20132

  • Local Institution

    Milan, 20142

  • Local Institution

    Naples, 80123

  • Local Institution

    Naples, 80131

  • Local Institution

    Palermo, 90127

  • Local Institution

    Pavia, 27100

  • Local Institution

    Perugia, 06132

  • Local Institution

    Piacenza, 29100

  • Local Institution

    Reggio Emilia, 42100

  • Local Institution

    Roma, 00128

  • Local Institution

    Roma, 00135

  • Local Institution

    Roma, 00161

  • Local Institution

    San Daniele Del Friuli(udine), 33038

  • Local Institution

    Siena, 53100

  • Local Institution

    Torino, 10126

  • Local Institution

    Treviso, 31100

  • Local Institution

    Varese, 21100

  • Local Institution

    Vicenza, 36100

  • Local Institution

    Vimercate, 20059

  • Local Institution

    Viterbo, 01100

Other trials in Italy

Spain18 sites

  • Local Institution

    Aldaia, 46960

  • Local Institution

    Alicante, 03015

  • Local Institution

    Barcelona, 08013

  • Local Institution

    Barcelona, 08025

  • Local Institution

    Barcelona, 08036

  • Local Institution

    Galdakao, 48960

  • Local Institution

    Madrid, 28009

  • Local Institution

    Madrid, 28033

  • Local Institution

    Madrid, 28046

  • Local Institution

    Murcia, 30120 El Palmar

  • Local Institution

    Oviedo, 33006

  • Local Institution

    San Sebastián de los Reyes, Madrid, 28702

  • Local Institution

    Santiago de Compostela, 15706

  • Local Institution

    Tarragona, 43007

  • Local Institution

    Valencia, 46010

  • Local Institution

    Valencia, 46026

  • Local Institution

    Viladecans, 08840

  • Local Institution

    Zaragoza, 50009

Other trials in Spain

United Kingdom17 sites

  • Local Institution

    Airdrie, Lancashire, ML6 OJS

  • Local Institution

    Ashford, KENT, TN24 0LZ

  • Local Institution

    Birmingham, WEST Midlands, B18 7QH

  • Local Institution

    Bournemouth, Dorset, BH7 7DW

  • Local Institution

    Craigavon, Armagh, BT63 5QQ

  • Local Institution

    Darlington, County Durham, DL3 8SQ

  • Local Institution

    Dudley, WEST Midlands, DY1 2HQ

  • Local Institution

    Exeter, Devon, EX2 5DW

  • Local Institution

    Glasgow, Lanarkshire, G75 8RG

  • Local Institution

    Hereford, HR12ER

  • Local Institution

    Liverpool, Merseyside, L7 8XP

  • Local Institution

    Oldham, OL12JH

  • Local Institution

    Poole, Dorset, BH15 2JB

  • Local Institution

    Somerset, BA21 4AT

  • Local Institution

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • Local Institution

    Tauton, TA1 5DA

  • Local Institution

    Westcliff-on-Sea, Essex, SS0 0RT

Other trials in United Kingdom

Belgium15 sites

  • Local Institution

    Antwerp, 2060

  • Local Institution

    Arlon, 6700

  • Local Institution

    Bonheiden, 2820

  • Local Institution

    Braine-l'Alleud, 1420

  • Local Institution

    Brussels, 1020

  • Local Institution

    Brussels, 1090

  • Local Institution

    Ghent, 9000

  • Local Institution

    Gilly, 6060

  • Local Institution

    Hasselt, 3500

  • Local Institution

    Leuven, 3000

  • Local Institution

    Liège, 4000

  • Local Institution

    Ronse, 9600

  • Local Institution

    Woluwe-Saint-Lambert, 1200

  • Local Institution

    Yvoir, 5530

  • Local Institution

    Yvoir, B-5530

Other trials in Belgium

Switzerland7 sites

  • Local Institution

    Baden, 5404

  • Local Institution

    Bern, 3004

  • Local Institution

    Fribourg, Canton, 1708

  • Local Institution

    Lugano, Canton Ticino, 6900

  • Local Institution

    Winterthur, 8401

  • Local Institution

    Zurich, 8032

  • Local Institution

    Zurich, 8063

Other trials in Switzerland

About this study

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

Read the 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

Being tested
Apixaban

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ApixabanDrug

    Also called Eliquis, BMS-562247

Study groups in NCT01884350
Study groupRoleWhat they receive
Arm 1: Apixaban (Primary SOC information)ExperimentalApixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Primary Standard of Care (SOC) information
Receives: Drug: Apixaban
Arm 2: Apixaban (Additional Educational Program)ExperimentalApixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Additional Educational Program
Receives: Drug: Apixaban

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Day 1 up to week 24

Secondary outcomes (5)

  1. 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

    The mean adherence to apixaban treatment during the first 24 weeks was measured between the standard of care (SOC) information and Additional Education Program (AEP) arms and expressed as a percentage. Adherence to Apixaban = number of units of adherence *100 / total number of eligible days for the time period.

    Measured: Day 1 to Week 12, Week 12 to Week 24

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

    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 over 24 weeks was calculated as the percentage of adherence units within that period. If a participant discontinued from the study before 48 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.

    Measured: Week 24 to Week 48

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

    Logit analyses were conducted on the Primary Efficacy Set to identify non-adherence predictors of 20% or more (vs. at least 80% adherence) at 24 weeks. In the Primary SOC group, alcohol use, Mini-Mental State Evaluation (MMSE) score, UK standard occupational classification, and type of atrial fibrillation were retained in the model (p-value <= 0.2). In the Additional Educational Program group, alcohol use, type of atrial fibrillation, age and Vitamin K Antagonists (VKA) status were retained in the model (p-value <= 0.2). Odds ratios are presented for predictors of non-adherence.

    Measured: Week 24

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

    AEs with onset date from day 1 through week 24 are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.

    Measured: Day 1 up to week 24

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

    Adverse events with onset date after 24 weeks are included in this summary. AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible, or missing relationship to study drug.

    Measured: Week 24 up to Week 48

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2013 (estimated)
  2. Study start15 Oct 2013
  3. Primary completion20 Jan 2016
  4. Study completion20 Jan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
1,217 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01884350
Sponsor's protocol ID
CV185-220
Other IDs
2013-000055-41
Acronym
AEGEAN
Status last verified
Jul 2019
First submitted
13 Jun 2013
Last updated
19 Aug 2019
Data monitoring committee
No

Publications

  • 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.

    PubMed 31243691

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Apixaban in people with Non-valvular Atrial Fibrillation, run by Bristol-Myers Squibb at 220 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 220 sites in France, Germany, Italy, Spain, United Kingdom and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen (time frame: Day 1 up to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01884350, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.

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