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

Non-valvular Atrial Fibrillation Clinical Trial

— AEGEAN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01884350
• Other study ID #: CV185-220
• Secondary ID: 2013-000055-41
• Status: Completed
• Phase: Phase 4
• Start date: October 15, 2013
• Est. completion date: January 20, 2016

Study information

• Verified date: July 2019
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1217
• Est. completion date: January 20, 2016
• Est. primary completion date: January 20, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Non-valvular Atrial Fibrillation

Intervention

Drug:
• Apixaban

Locations

Country	Name	City	State
Belgium	Local Institution	Antwerpen
Belgium	Local Institution	Arlon
Belgium	Local Institution	Bonheiden
Belgium	Local Institution	Braine-l'alleud
Belgium	Local Institution	Brussels
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	Gent
Belgium	Local Institution	Gilly
Belgium	Local Institution	Hasselt
Belgium	Local Institution	Leuven
Belgium	Local Institution	Liege
Belgium	Local Institution	Ronse
Belgium	Local Institution	Woluwe- Saint Lambert
Belgium	Local Institution	Yvoir
Belgium	Local Institution	Yvoir
France	Local Institution	Abbeville
France	Local Institution	Aix En Provence
France	Local Institution	Avignon
France	Local Institution	Avignon Cedex 9
France	Local Institution	Bayonne
France	Local Institution	Bayonne Cedex
France	Local Institution	Beziers Cedex
France	Local Institution	Bobigny
France	Local Institution	Bordeaux
France	Local Institution	Bordeaux
France	Local Institution	Boulogne-billancourt
France	Local Institution	Brest
France	Local Institution	Bron
France	Local Institution	Caen
France	Local Institution	Cambrai
France	Local Institution	Cannes
France	Local Institution	Chambray-les- Tours
France	Local Institution	Chartes
France	Local Institution	Chatellerault
France	Local Institution	Cholet
France	Local Institution	Clermont Ferrand
France	Local Institution	Colombes
France	Local Institution	Corbeil Essonnes
France	Local Institution	Creteil Cedex
France	Local Institution	Dijon Cedex
France	Local Institution	Grenoble Cedex 09
France	Local Institution	Grenoble Cedex 9
France	Local Institution	Haguenau Cedex
France	Local Institution	La Rochelle Cedex
France	Local Institution	Le Chesnay
France	Local Institution	Lille
France	Local Institution	Lille Cedex
France	Local Institution	Longjumeau
France	Local Institution	Marseille
France	Local Institution	Marseille
France	Local Institution	Marseille
France	Local Institution	Marseille Cedex 20
France	Local Institution	Montfermeil
France	Local Institution	Montpellier
France	Local Institution	Montpellier
France	Local Institution	Nantes Cedex 2
France	Local Institution	Neuilly Sur Seine
France	Local Institution	Nice
France	Local Institution	Nimes Cedex 9
France	Local Institution	Orleans Cedex 2
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Paris
France	Local Institution	Paris Cedex
France	Local Institution	Paris Cedex 14
France	Local Institution	Pau Universite Cedex
France	Local Institution	Pessac
France	Local Institution	Plan de Cuques
France	Local Institution	Rennes Cedex 9
France	Local Institution	Saint Denis
France	Local Institution	Saint Etienne	Cedex 2
France	Local Institution	Salouel
France	Local Institution	Sete
France	Local Institution	St. Benoit
France	Local Institution	Strasbourg
France	Local Institution	Strasbourg
France	Local Institution	Thionville
France	Local Institution	Thonon Les Bains
France	Local Institution	Toulouse
France	Local Institution	Toulouse Cedex 3
France	Local Institution	Tourcoing
France	Local Institution	Valence
France	Local Institution	Valenciennes Cedex
France	Local Institution	Vesoul
France	Local Institution	Wardenburg
Germany	Local Institution	Augsburg
Germany	Local Institution	Aurich
Germany	Local Institution	Bad Homburg
Germany	Local Institution	Balingen
Germany	Local Institution	Bamberg
Germany	Local Institution	Berin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Chemnitz
Germany	Local Institution	Deggingen
Germany	Local Institution	Dillingen
Germany	Local Institution	Dresden
Germany	Local Institution	Dresden
Germany	Local Institution	Erfurt
Germany	Local Institution	Essen
Germany	Local Institution	Floersheim
Germany	Local Institution	Friedberg
Germany	Local Institution	Gars/Inn
Germany	Local Institution	Gottingen
Germany	Local Institution	Grossheirath Rossbach
Germany	Local Institution	Hamburg
Germany	Local Institution	Hamburg
Germany	Local Institution	Hassloch
Germany	Local Institution	Heidelberg
Germany	Local Institution	Heidenau
Germany	Local Institution	Kassel
Germany	Local Institution	Kelkheim
Germany	Local Institution	Krombach	Bayern
Germany	Local Institution	Kuenzing
Germany	Local Institution	Langestrasse
Germany	Local Institution	Leipzig
Germany	Local Institution	Lollar
Germany	Local Institution	Ludwigsburg
Germany	Local Institution	Ludwigsburg
Germany	Local Institution	Mammendorf
Germany	Local Institution	Mannheim
Germany	Local Institution	Mannheim
Germany	Local Institution	Markkleeberg
Germany	Local Institution	Munster
Germany	Local Institution	Myen
Germany	Local Institution	Neukirchen
Germany	Local Institution	Neunirchen
Germany	Local Institution	Northeim
Germany	Local Institution	Obermichelbach
Germany	Local Institution	Papenburg
Germany	Local Institution	Pirna
Germany	Local Institution	Riesa
Germany	Local Institution	Rodgau
Germany	Local Institution	Rotenburg /fulda
Germany	Local Institution	Sinzheim
Germany	Local Institution	Spaichingen	Baden-wurttembe
Germany	Local Institution	Stockach
Germany	Local Institution	Unterschneidheim
Germany	Local Institution	Wallerfing
Germany	Local Institution	Wangen
Germany	Local Institution	Weissenhorn
Germany	Local Institution	Wermsdorf
Germany	Local Institution	Wetzlar
Germany	Local Institution	Weyhe
Germany	Local Institution	Winsen
Italy	Local Institution	Arezzo
Italy	Local Institution	Bologna
Italy	Local Institution	Castelfranco Veneto (tv)
Italy	Local Institution	Catanzaro
Italy	Local Institution	Cremona
Italy	Local Institution	Firenze
Italy	Local Institution	Firenze
Italy	Local Institution	Florence
Italy	Local Institution	Foggia
Italy	Local Institution	L'Aquila
Italy	Local Institution	Mestre
Italy	Local Institution	Milano
Italy	Local Institution	Milano
Italy	Local Institution	Milano	MI
Italy	Local Institution	Naples
Italy	Local Institution	Napoli
Italy	Local Institution	Palermo
Italy	Local Institution	Pavia
Italy	Local Institution	Perugia
Italy	Local Institution	Piacenza
Italy	Local Institution	Reggio Emilia
Italy	Local Institution	Roma
Italy	Local Institution	Roma
Italy	Local Institution	Roma
Italy	Local Institution	San Daniele Del Friuli(udine)
Italy	Local Institution	Siena
Italy	Local Institution	Torino
Italy	Local Institution	Treviso
Italy	Local Institution	Varese
Italy	Local Institution	Vicenza
Italy	Local Institution	Vimercate
Italy	Local Institution	Viterbo
Spain	Local Institution	Aldaya
Spain	Local Institution	Alicante
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Galdacano
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Murcia
Spain	Local Institution	Oviedo
Spain	Local Institution	San Sebastian De Los Reyes	Madrid
Spain	Local Institution	Santiago De Compostela
Spain	Local Institution	Tarragona
Spain	Local Institution	Valencia
Spain	Local Institution	Valencia
Spain	Local Institution	Viladecans
Spain	Local Institution	Zaragoza
Switzerland	Local Institution	Baden
Switzerland	Local Institution	Bern 4
Switzerland	Local Institution	Fribourg	Canton
Switzerland	Local Institution	Lugano	Ticino
Switzerland	Local Institution	Winterthur
Switzerland	Local Institution	Zurich
Switzerland	Local Institution	Zurich
United Kingdom	Local Institution	Airdrie	Lancashire
United Kingdom	Local Institution	Ashford	Kent
United Kingdom	Local Institution	Birmingham	WEST Midlands
United Kingdom	Local Institution	Bournemouth	Dorset
United Kingdom	Local Institution	Craigavon	Armagh
United Kingdom	Local Institution	Darlington	County Durham
United Kingdom	Local Institution	Dudley	WEST Midlands
United Kingdom	Local Institution	Exeter	Devon
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	Hereford
United Kingdom	Local Institution	Liverpool	Merseyside
United Kingdom	Local Institution	Oldham
United Kingdom	Local Institution	Poole	Dorset
United Kingdom	Local Institution	Somerset
United Kingdom	Local Institution	Stoke-on-trent	Staffordshire
United Kingdom	Local Institution	Tauton
United Kingdom	Local Institution	Westcliff-on-sea	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

Belgium,  France,  Germany,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 1 to Week 12, Week 12 to Week 24
Secondary	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.	Week 24 to Week 48
Secondary	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.	Week 24
Secondary	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.	Day 1 up to week 24
Secondary	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.	Week 24 up to Week 48

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