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

Primary Purpose

Non-valvular Atrial Fibrillation

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Apixaban
Sponsored by
Bristol-Myers Squibb
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-valvular Atrial Fibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1: Apixaban (Primary SOC information)

Arm 2: Apixaban (Additional Educational Program)

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
June 13, 2013
Last Updated
July 10, 2019
Sponsor
Bristol-Myers Squibb
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1. Study Identification

Unique Protocol Identification Number
NCT01884350
Brief Title
Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
Acronym
AEGEAN
Official Title
Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
October 15, 2013 (Actual)
Primary Completion Date
January 20, 2016 (Actual)
Study Completion Date
January 20, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-valvular Atrial Fibrillation

7. Study Design

Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1217 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1: Apixaban (Primary SOC information)
Arm Type
Experimental
Arm Description
Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Primary Standard of Care (SOC) information
Arm Title
Arm 2: Apixaban (Additional Educational Program)
Arm Type
Experimental
Arm Description
Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Additional Educational Program
Intervention Type
Drug
Intervention Name(s)
Apixaban
Other Intervention Name(s)
Eliquis, BMS-562247
Primary Outcome Measure Information:
Title
Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen
Description
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.
Time Frame
Day 1 up to week 24
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Day 1 to Week 12, Week 12 to Week 24
Title
Percentage of Days With a Correct Execution of the Apixaban Dosing Regimen During the 24 to 48 Weeks Period
Description
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.
Time Frame
Week 24 to Week 48
Title
Non-adherence Predictors of 20% or More (vs. at Least 80% Adherence) at 24 Weeks
Description
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.
Time Frame
Week 24
Title
Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death
Description
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.
Time Frame
Day 1 up to week 24
Title
Number of Participants With Serious Adverse Events (SAEs), Drug Related Adverse Events (AE), AE Leading to Discontinuation, and Death
Description
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.
Time Frame
Week 24 up to Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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: 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 Vascular aneurysms Major intraspinal or intracerebral vascular abnormalities Documented hemorrhagic tendencies or blood dyscrasias Presence of malignant neoplasms at high risk of bleeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bristol-Myers Squibb
Organizational Affiliation
Bristol-Myers Squibb
Official's Role
Study Director
Facility Information:
Facility Name
Local Institution
City
Antwerpen
ZIP/Postal Code
2060
Country
Belgium
Facility Name
Local Institution
City
Arlon
ZIP/Postal Code
6700
Country
Belgium
Facility Name
Local Institution
City
Bonheiden
ZIP/Postal Code
2820
Country
Belgium
Facility Name
Local Institution
City
Braine-l'alleud
ZIP/Postal Code
1420
Country
Belgium
Facility Name
Local Institution
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Local Institution
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Local Institution
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Local Institution
City
Gilly
ZIP/Postal Code
6060
Country
Belgium
Facility Name
Local Institution
City
Hasselt
ZIP/Postal Code
3500
Country
Belgium
Facility Name
Local Institution
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Local Institution
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Local Institution
City
Ronse
ZIP/Postal Code
9600
Country
Belgium
Facility Name
Local Institution
City
Woluwe- Saint Lambert
ZIP/Postal Code
1200
Country
Belgium
Facility Name
Local Institution
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Local Institution
City
Yvoir
ZIP/Postal Code
B-5530
Country
Belgium
Facility Name
Local Institution
City
Saint Etienne
State/Province
Cedex 2
ZIP/Postal Code
42055
Country
France
Facility Name
Local Institution
City
Abbeville
ZIP/Postal Code
80142
Country
France
Facility Name
Local Institution
City
Aix En Provence
ZIP/Postal Code
13616
Country
France
Facility Name
Local Institution
City
Avignon Cedex 9
ZIP/Postal Code
84902
Country
France
Facility Name
Local Institution
City
Avignon
ZIP/Postal Code
84000
Country
France
Facility Name
Local Institution
City
Bayonne Cedex
ZIP/Postal Code
64109
Country
France
Facility Name
Local Institution
City
Bayonne
ZIP/Postal Code
64100
Country
France
Facility Name
Local Institution
City
Beziers Cedex
ZIP/Postal Code
34525
Country
France
Facility Name
Local Institution
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Local Institution
City
Bordeaux
ZIP/Postal Code
33075
Country
France
Facility Name
Local Institution
City
Boulogne-billancourt
ZIP/Postal Code
92100
Country
France
Facility Name
Local Institution
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Local Institution
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Local Institution
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
Local Institution
City
Cambrai
ZIP/Postal Code
59407
Country
France
Facility Name
Local Institution
City
Cannes
ZIP/Postal Code
06400
Country
France
Facility Name
Local Institution
City
Chambray-les- Tours
ZIP/Postal Code
37044
Country
France
Facility Name
Local Institution
City
Chartes
ZIP/Postal Code
28108
Country
France
Facility Name
Local Institution
City
Chatellerault
ZIP/Postal Code
86106
Country
France
Facility Name
Local Institution
City
Cholet
ZIP/Postal Code
49309
Country
France
Facility Name
Local Institution
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Local Institution
City
Colombes
ZIP/Postal Code
92701
Country
France
Facility Name
Local Institution
City
Corbeil Essonnes
ZIP/Postal Code
91106
Country
France
Facility Name
Local Institution
City
Creteil Cedex
ZIP/Postal Code
94010
Country
France
Facility Name
Local Institution
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
Local Institution
City
Grenoble Cedex 09
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Grenoble Cedex 9
ZIP/Postal Code
38043
Country
France
Facility Name
Local Institution
City
Haguenau Cedex
ZIP/Postal Code
67502
Country
France
Facility Name
Local Institution
City
La Rochelle Cedex
ZIP/Postal Code
17019
Country
France
Facility Name
Local Institution
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Facility Name
Local Institution
City
Lille Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Local Institution
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Local Institution
City
Longjumeau
ZIP/Postal Code
91164
Country
France
Facility Name
Local Institution
City
Marseille Cedex 20
ZIP/Postal Code
13915
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13003
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Local Institution
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Local Institution
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Local Institution
City
Montpellier
ZIP/Postal Code
34000
Country
France
Facility Name
Local Institution
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Local Institution
City
Nantes Cedex 2
ZIP/Postal Code
44277
Country
France
Facility Name
Local Institution
City
Neuilly Sur Seine
ZIP/Postal Code
92523
Country
France
Facility Name
Local Institution
City
Nice
ZIP/Postal Code
06105
Country
France
Facility Name
Local Institution
City
Nimes Cedex 9
ZIP/Postal Code
30029
Country
France
Facility Name
Local Institution
City
Orleans Cedex 2
ZIP/Postal Code
45067
Country
France
Facility Name
Local Institution
City
Paris Cedex 14
ZIP/Postal Code
75674
Country
France
Facility Name
Local Institution
City
Paris Cedex
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75013
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75015
Country
France
Facility Name
Local Institution
City
Paris
ZIP/Postal Code
75908
Country
France
Facility Name
Local Institution
City
Pau Universite Cedex
ZIP/Postal Code
64046
Country
France
Facility Name
Local Institution
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Local Institution
City
Plan de Cuques
ZIP/Postal Code
13380
Country
France
Facility Name
Local Institution
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
Local Institution
City
Saint Denis
ZIP/Postal Code
93207
Country
France
Facility Name
Local Institution
City
Salouel
ZIP/Postal Code
80480
Country
France
Facility Name
Local Institution
City
Sete
ZIP/Postal Code
34200
Country
France
Facility Name
Local Institution
City
St. Benoit
ZIP/Postal Code
86280
Country
France
Facility Name
Local Institution
City
Strasbourg
ZIP/Postal Code
67000
Country
France
Facility Name
Local Institution
City
Strasbourg
ZIP/Postal Code
67090
Country
France
Facility Name
Local Institution
City
Thionville
ZIP/Postal Code
57100
Country
France
Facility Name
Local Institution
City
Thonon Les Bains
ZIP/Postal Code
74203
Country
France
Facility Name
Local Institution
City
Toulouse Cedex 3
ZIP/Postal Code
31076
Country
France
Facility Name
Local Institution
City
Toulouse
ZIP/Postal Code
31054
Country
France
Facility Name
Local Institution
City
Tourcoing
ZIP/Postal Code
59208
Country
France
Facility Name
Local Institution
City
Valence
ZIP/Postal Code
26000
Country
France
Facility Name
Local Institution
City
Valenciennes Cedex
ZIP/Postal Code
59322
Country
France
Facility Name
Local Institution
City
Vesoul
ZIP/Postal Code
70014
Country
France
Facility Name
Local Institution
City
Wardenburg
ZIP/Postal Code
26203
Country
France
Facility Name
Local Institution
City
Spaichingen
State/Province
Baden-wurttembe
ZIP/Postal Code
78549
Country
Germany
Facility Name
Local Institution
City
Krombach
State/Province
Bayern
ZIP/Postal Code
63829
Country
Germany
Facility Name
Local Institution
City
Augsburg
ZIP/Postal Code
86159
Country
Germany
Facility Name
Local Institution
City
Aurich
ZIP/Postal Code
26603
Country
Germany
Facility Name
Local Institution
City
Bad Homburg
ZIP/Postal Code
61348
Country
Germany
Facility Name
Local Institution
City
Balingen
ZIP/Postal Code
72336
Country
Germany
Facility Name
Local Institution
City
Bamberg
Country
Germany
Facility Name
Local Institution
City
Berin
ZIP/Postal Code
10559
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10367
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
12351
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
12524
Country
Germany
Facility Name
Local Institution
City
Berlin
ZIP/Postal Code
13405
Country
Germany
Facility Name
Local Institution
City
Chemnitz
ZIP/Postal Code
09122
Country
Germany
Facility Name
Local Institution
City
Deggingen
ZIP/Postal Code
73326
Country
Germany
Facility Name
Local Institution
City
Dillingen
ZIP/Postal Code
66763
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01099
Country
Germany
Facility Name
Local Institution
City
Dresden
ZIP/Postal Code
01277
Country
Germany
Facility Name
Local Institution
City
Erfurt
ZIP/Postal Code
99084
Country
Germany
Facility Name
Local Institution
City
Essen
ZIP/Postal Code
45138
Country
Germany
Facility Name
Local Institution
City
Floersheim
ZIP/Postal Code
65439
Country
Germany
Facility Name
Local Institution
City
Friedberg
Country
Germany
Facility Name
Local Institution
City
Gars/Inn
ZIP/Postal Code
83536
Country
Germany
Facility Name
Local Institution
City
Gottingen
ZIP/Postal Code
37073
Country
Germany
Facility Name
Local Institution
City
Grossheirath Rossbach
ZIP/Postal Code
96269
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
22299
Country
Germany
Facility Name
Local Institution
City
Hamburg
ZIP/Postal Code
22459
Country
Germany
Facility Name
Local Institution
City
Hassloch
ZIP/Postal Code
67454
Country
Germany
Facility Name
Local Institution
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Local Institution
City
Heidenau
ZIP/Postal Code
01809
Country
Germany
Facility Name
Local Institution
City
Kassel
ZIP/Postal Code
34117
Country
Germany
Facility Name
Local Institution
City
Kelkheim
ZIP/Postal Code
65779
Country
Germany
Facility Name
Local Institution
City
Kuenzing
ZIP/Postal Code
94550
Country
Germany
Facility Name
Local Institution
City
Langestrasse
ZIP/Postal Code
04910
Country
Germany
Facility Name
Local Institution
City
Leipzig
ZIP/Postal Code
04104
Country
Germany
Facility Name
Local Institution
City
Lollar
ZIP/Postal Code
35457
Country
Germany
Facility Name
Local Institution
City
Ludwigsburg
ZIP/Postal Code
71634
Country
Germany
Facility Name
Local Institution
City
Ludwigsburg
ZIP/Postal Code
71640
Country
Germany
Facility Name
Local Institution
City
Mammendorf
ZIP/Postal Code
82291
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Local Institution
City
Mannheim
ZIP/Postal Code
68163
Country
Germany
Facility Name
Local Institution
City
Markkleeberg
ZIP/Postal Code
04416
Country
Germany
Facility Name
Local Institution
City
Munster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Local Institution
City
Myen
ZIP/Postal Code
56727
Country
Germany
Facility Name
Local Institution
City
Neukirchen
ZIP/Postal Code
66539
Country
Germany
Facility Name
Local Institution
City
Neunirchen
ZIP/Postal Code
66540
Country
Germany
Facility Name
Local Institution
City
Northeim
ZIP/Postal Code
37154
Country
Germany
Facility Name
Local Institution
City
Obermichelbach
Country
Germany
Facility Name
Local Institution
City
Papenburg
ZIP/Postal Code
D-26871
Country
Germany
Facility Name
Local Institution
City
Pirna
ZIP/Postal Code
01796
Country
Germany
Facility Name
Local Institution
City
Riesa
ZIP/Postal Code
D-01587
Country
Germany
Facility Name
Local Institution
City
Rodgau
ZIP/Postal Code
63110
Country
Germany
Facility Name
Local Institution
City
Rotenburg /fulda
ZIP/Postal Code
36199
Country
Germany
Facility Name
Local Institution
City
Sinzheim
ZIP/Postal Code
76547
Country
Germany
Facility Name
Local Institution
City
Stockach
ZIP/Postal Code
78333
Country
Germany
Facility Name
Local Institution
City
Unterschneidheim
ZIP/Postal Code
73485
Country
Germany
Facility Name
Local Institution
City
Wallerfing
ZIP/Postal Code
94574
Country
Germany
Facility Name
Local Institution
City
Wangen
ZIP/Postal Code
88239
Country
Germany
Facility Name
Local Institution
City
Weissenhorn
ZIP/Postal Code
89264
Country
Germany
Facility Name
Local Institution
City
Wermsdorf
ZIP/Postal Code
04779
Country
Germany
Facility Name
Local Institution
City
Wetzlar
ZIP/Postal Code
35584
Country
Germany
Facility Name
Local Institution
City
Weyhe
ZIP/Postal Code
28844
Country
Germany
Facility Name
Local Institution
City
Winsen
ZIP/Postal Code
21423
Country
Germany
Facility Name
Local Institution
City
Milano
State/Province
MI
ZIP/Postal Code
20122
Country
Italy
Facility Name
Local Institution
City
Arezzo
ZIP/Postal Code
52100
Country
Italy
Facility Name
Local Institution
City
Bologna
ZIP/Postal Code
40133
Country
Italy
Facility Name
Local Institution
City
Castelfranco Veneto (tv)
ZIP/Postal Code
31033
Country
Italy
Facility Name
Local Institution
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Local Institution
City
Cremona
ZIP/Postal Code
26100
Country
Italy
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50122
Country
Italy
Facility Name
Local Institution
City
Firenze
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution
City
Florence
ZIP/Postal Code
50134
Country
Italy
Facility Name
Local Institution
City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
Local Institution
City
L'Aquila
ZIP/Postal Code
67100
Country
Italy
Facility Name
Local Institution
City
Mestre
ZIP/Postal Code
30174
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Local Institution
City
Milano
ZIP/Postal Code
20142
Country
Italy
Facility Name
Local Institution
City
Naples
ZIP/Postal Code
80123
Country
Italy
Facility Name
Local Institution
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Local Institution
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Local Institution
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Facility Name
Local Institution
City
Perugia
ZIP/Postal Code
06132
Country
Italy
Facility Name
Local Institution
City
Piacenza
ZIP/Postal Code
29100
Country
Italy
Facility Name
Local Institution
City
Reggio Emilia
ZIP/Postal Code
42100
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00135
Country
Italy
Facility Name
Local Institution
City
Roma
ZIP/Postal Code
00161
Country
Italy
Facility Name
Local Institution
City
San Daniele Del Friuli(udine)
ZIP/Postal Code
33038
Country
Italy
Facility Name
Local Institution
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Local Institution
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Local Institution
City
Treviso
ZIP/Postal Code
31100
Country
Italy
Facility Name
Local Institution
City
Varese
ZIP/Postal Code
21100
Country
Italy
Facility Name
Local Institution
City
Vicenza
ZIP/Postal Code
36100
Country
Italy
Facility Name
Local Institution
City
Vimercate
ZIP/Postal Code
20059
Country
Italy
Facility Name
Local Institution
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Facility Name
Local Institution
City
San Sebastian De Los Reyes
State/Province
Madrid
ZIP/Postal Code
28702
Country
Spain
Facility Name
Local Institution
City
Aldaya
ZIP/Postal Code
46960
Country
Spain
Facility Name
Local Institution
City
Alicante
ZIP/Postal Code
03015
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08013
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Local Institution
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Local Institution
City
Galdacano
ZIP/Postal Code
48960
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28033
Country
Spain
Facility Name
Local Institution
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Local Institution
City
Murcia
ZIP/Postal Code
30120 El Palmar
Country
Spain
Facility Name
Local Institution
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Local Institution
City
Santiago De Compostela
ZIP/Postal Code
15706
Country
Spain
Facility Name
Local Institution
City
Tarragona
ZIP/Postal Code
43007
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Local Institution
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Local Institution
City
Viladecans
ZIP/Postal Code
08840
Country
Spain
Facility Name
Local Institution
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Local Institution
City
Fribourg
State/Province
Canton
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Local Institution
City
Lugano
State/Province
Ticino
ZIP/Postal Code
6900
Country
Switzerland
Facility Name
Local Institution
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Local Institution
City
Bern 4
ZIP/Postal Code
3004
Country
Switzerland
Facility Name
Local Institution
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Local Institution
City
Zurich
ZIP/Postal Code
8032
Country
Switzerland
Facility Name
Local Institution
City
Zurich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Local Institution
City
Craigavon
State/Province
Armagh
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Facility Name
Local Institution
City
Darlington
State/Province
County Durham
ZIP/Postal Code
DL3 8SQ
Country
United Kingdom
Facility Name
Local Institution
City
Exeter
State/Province
Devon
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Local Institution
City
Bournemouth
State/Province
Dorset
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Local Institution
City
Poole
State/Province
Dorset
ZIP/Postal Code
BH15 2JB
Country
United Kingdom
Facility Name
Local Institution
City
Westcliff-on-sea
State/Province
Essex
ZIP/Postal Code
SS0 0RT
Country
United Kingdom
Facility Name
Local Institution
City
Ashford
State/Province
Kent
ZIP/Postal Code
TN24 0LZ
Country
United Kingdom
Facility Name
Local Institution
City
Glasgow
State/Province
Lanarkshire
ZIP/Postal Code
G75 8RG
Country
United Kingdom
Facility Name
Local Institution
City
Airdrie
State/Province
Lancashire
ZIP/Postal Code
ML6 OJS
Country
United Kingdom
Facility Name
Local Institution
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Local Institution
City
Stoke-on-trent
State/Province
Staffordshire
ZIP/Postal Code
ST4 6QG
Country
United Kingdom
Facility Name
Local Institution
City
Birmingham
State/Province
WEST Midlands
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Local Institution
City
Dudley
State/Province
WEST Midlands
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Local Institution
City
Hereford
ZIP/Postal Code
HR12ER
Country
United Kingdom
Facility Name
Local Institution
City
Oldham
ZIP/Postal Code
OL12JH
Country
United Kingdom
Facility Name
Local Institution
City
Somerset
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Facility Name
Local Institution
City
Tauton
ZIP/Postal Code
TA1 5DA
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
31243691
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.
Results Reference
derived
Links:
URL
https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
Description
BMS Clinical Trial Information
URL
https://www.bmsstudyconnect.com/s/US/English/USenHome
Description
BMS Clinical Trial Patient Recruiting
URL
https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls

Learn more about this trial

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

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