Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
NCT ID: NCT01884350
Last Updated: 2019-08-19
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
1217 participants
INTERVENTIONAL
2013-10-15
2016-01-20
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Arm 1: Apixaban (Primary SOC information)
Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Primary Standard of Care (SOC) information
Apixaban
Arm 2: Apixaban (Additional Educational Program)
Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Additional Educational Program
Apixaban
Interventions
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Apixaban
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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. 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
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Antwerp, , Belgium
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Arlon, , Belgium
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Bonheiden, , Belgium
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Braine-l'Alleud, , Belgium
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Brussels, , Belgium
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Brussels, , Belgium
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Ghent, , Belgium
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Gilly, , Belgium
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Hasselt, , Belgium
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Leuven, , Belgium
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Liège, , Belgium
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Ronse, , Belgium
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Woluwe-Saint-Lambert, , Belgium
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Yvoir, , Belgium
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Yvoir, , Belgium
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Saint-Etienne, Cedex 2, France
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Abbeville, , France
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Aix-en-Provence, , France
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Avignon, , France
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Avignon, , France
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Bayonne, , France
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Bayonne, , France
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Béziers, , France
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Bobigny, , France
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Bordeaux, , France
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Bordeaux, , France
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Boulogne-Billancourt, , France
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Brest, , France
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Bron, , France
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Caen, , France
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Cambrai, , France
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Cannes, , France
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Chambray-lès-Tours, , France
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Chartes, , France
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Châtellerault, , France
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Cholet, , France
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Clermont-Ferrand, , France
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Colombes, , France
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Corbeil-Essonnes, , France
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Créteil, , France
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Dijon, , France
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Grenoble, , France
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Haguenau, , France
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La Rochelle, , France
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Le Chesnay, , France
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Lille, , France
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Lille, , France
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Longjumeau, , France
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Marseille, , France
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Marseille, , France
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Marseille, , France
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Marseille, , France
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Montfermeil, , France
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Montpellier, , France
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Montpellier, , France
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Nantes, , France
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Neuilly-sur-Seine, , France
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Nice, , France
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Nîmes, , France
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Orléans, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Paris, , France
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Pau Universite Cedex, , France
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Pessac, , France
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Plan-de-Cuques, , France
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Rennes, , France
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Saint-Benoît, , France
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Saint-Denis, , France
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Salouël, , France
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Sète, , France
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Strasbourg, , France
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Strasbourg, , France
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Thionville, , France
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Thonon-les-Bains, , France
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Toulouse, , France
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Toulouse, , France
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Tourcoing, , France
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Valence, , France
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Valenciennes, , France
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Vesoul, , France
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Wardenburg, , France
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Spaichingen, Baden-wurttembe, Germany
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Krombach, Bavaria, Germany
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Augsburg, , Germany
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Aurich, , Germany
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Bad Homburg, , Germany
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Balingen, , Germany
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Bamberg, , Germany
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Berin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Chemnitz, , Germany
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Deggingen, , Germany
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Dillingen, , Germany
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Dresden, , Germany
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Dresden, , Germany
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Erfurt, , Germany
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Essen, , Germany
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Flörsheim, , Germany
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Friedberg, , Germany
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Gars/Inn, , Germany
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Göttingen, , Germany
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Grossheirath Rossbach, , Germany
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Hamburg, , Germany
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Hamburg, , Germany
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Haßloch, , Germany
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Heidelberg, , Germany
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Heidenau, , Germany
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Kassel, , Germany
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Kelkheim, , Germany
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Künzing, , Germany
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Langestrasse, , Germany
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Leipzig, , Germany
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Lollar, , Germany
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Ludwigsburg, , Germany
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Ludwigsburg, , Germany
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Mammendorf, , Germany
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Mannheim, , Germany
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Mannheim, , Germany
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Markkleeberg, , Germany
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Münster, , Germany
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Myen, , Germany
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Neukirchen, , Germany
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Neunirchen, , Germany
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Northeim, , Germany
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Obermichelbach, , Germany
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Papenburg, , Germany
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Pirna, , Germany
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Riesa, , Germany
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Rodgau, , Germany
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Rotenburg /fulda, , Germany
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Sinzheim, , Germany
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Stockach, , Germany
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Unterschneidheim, , Germany
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Wallerfing, , Germany
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Wangen, , Germany
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Weißenhorn, , Germany
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Wermsdorf, , Germany
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Wetzlar, , Germany
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Weyhe, , Germany
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Winsen, , Germany
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Milan, MI, Italy
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Arezzo, , Italy
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Bologna, , Italy
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Castelfranco Veneto (tv), , Italy
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Catanzaro, , Italy
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Cremona, , Italy
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Florence, , Italy
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Florence, , Italy
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Foggia, , Italy
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L’Aquila, , Italy
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Mestre, , Italy
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Milan, , Italy
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Milan, , Italy
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Naples, , Italy
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Napoli, , Italy
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Palermo, , Italy
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Pavia, , Italy
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Perugia, , Italy
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Piacenza, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Roma, , Italy
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San Daniele Del Friuli(udine), , Italy
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Siena, , Italy
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Torino, , Italy
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Treviso, , Italy
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Varese, , Italy
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Vicenza, , Italy
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Vimercate, , Italy
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Viterbo, , Italy
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San Sebastián de los Reyes, Madrid, Spain
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Aldaia, , Spain
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Alicante, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Barcelona, , Spain
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Galdakao, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Murcia, , Spain
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Oviedo, , Spain
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Santiago de Compostela, , Spain
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Tarragona, , Spain
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Valencia, , Spain
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Valencia, , Spain
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Viladecans, , Spain
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Zaragoza, , Spain
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Lugano, Canton Ticino, Switzerland
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Fribourg, Canton, Switzerland
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Baden, , Switzerland
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Bern, , Switzerland
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Winterthur, , Switzerland
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Zurich, , Switzerland
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Zurich, , Switzerland
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Craigavon, Armagh, United Kingdom
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Darlington, County Durham, United Kingdom
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Exeter, Devon, United Kingdom
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Bournemouth, Dorset, United Kingdom
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Poole, Dorset, United Kingdom
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Westcliff-on-Sea, Essex, United Kingdom
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Ashford, KENT, United Kingdom
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Glasgow, Lanarkshire, United Kingdom
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Airdrie, Lancashire, United Kingdom
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Liverpool, Merseyside, United Kingdom
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Stoke-on-Trent, Staffordshire, United Kingdom
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Birmingham, WEST Midlands, United Kingdom
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Dudley, WEST Midlands, United Kingdom
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Hereford, , United Kingdom
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Oldham, , United Kingdom
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Somerset, , United Kingdom
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Tauton, , United Kingdom
Countries
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References
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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.
Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
Other Identifiers
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2013-000055-41
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CV185-220
Identifier Type: -
Identifier Source: org_study_id
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