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

• Conditions: Patients with Non-Valvular Atrial Fibrillation with at least one risk factor for stroke and indicated for oral anticoagulant.; MedDRA version: 16.1Level: PTClassification code 10003658Term: Atrial fibrillationSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2013-000055-41-BE
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10-28
• Last Update Posted: 11 April 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1112

Inclusion Criteria

- Signed Written Informed Consent.
- Patients with diagnosed non-valvular atrial fibrillation or atrial flutter (documented by 12-lead ECG or a Holter recording) and eligible for 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 (NYHA Class = II)
- Must be able to self-administer treatment.
- Either VKA treated or VKA naive.
VKA-treat patients must have received the VKA treatment for =3
months.
VKA-naïve patients must 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 (for
example, a patient treated with VKA for 40 days within the last 12 months) are not eligible for the study.
- Patients previously treated with ASA for stroke prevention are allowed (and will switch to apixaban).
- Patients with screening Mini-mental state examination score (MMSE) more than 24 (out of 30).
- Patient Re-enrollment: This study does not permit the re-enrollment of a patient that has discontinued the study as a pre-treatment failure.
- Men and women = 18 years of age.
- Women of childbearing potential (WOCBP) must use method(s) of contraception based on the tables in Appendix 43.
- WOCBP must have a negative urine pregnancy test (minimum
sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication.
- Women must not be breastfeeding.
- Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year.
- Women who are not of childbearing potential (ie, who are
postmenopausal or surgically sterile; see Section 3.3.3 for the definition of WOCBP) and azoospermic men do not require contraception.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 334
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 778

Exclusion Criteria

1) Target Disease Exceptions
a) Atrial fibrillation or flutter due to reversible causes (e.g.
thyrotoxicosis, pericarditis)
b) Clinically significant (moderate or severe) mitral stenosis
c) Cardiac valvular disease requiring surgery

2) Medical History and Concurrent Diseases
a) Conditions other than atrial fibrillation that require chronic
anticoagulation (e.g., prosthetic mechanical heart valve, venous
thromboembolism; also see Section 3.4, Concomitant Treatments).
b) 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 oesophageal varices
•Recent ischemic stroke (within 7 days)
•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
c) Persistent, uncontrolled hypertension (systolic BP > 180 mm Hg, and/or diastolic BP > 100 mm Hg)
d) Active infective endocarditis
e) Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
f) Active alcohol or drug abuse, or psychosocial reasons that make study participation impractical.
g) Severe co-morbid condition with life expectancy = 1 year

3) Physical and Laboratory Test Findings
a) Severe renal insufficiency (creatinine clearance must be calculated - Cockroft-Gault - in all patients; any patient with a calculated creatinine clearance <15 ml/min is excluded) or patients undergoing dialysis.
b) ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 2 times upper limit of normal or a total bilirubin > 1.5 times upper limit of normal (unless an alternative causative factor [e.g., Gilbert's syndrome] is identified)
c) Haemoglobin < 9 g/dL
d) Platelet count < 100,000/mm3

4) Allergies and Adverse Drug Reaction
a) Allergy or adverse reaction to apixaban or any of the excipients

5) Sex and Reproductive Status
a) Women who are pregnant or breast feeding
b) Women of child bearing potential (WOCBP, see Section 3.3.3 for
definition) who are unwilling to meet the study requirements for
pregnancy testing or are unwilling or unable to use an acceptable
method to avoid pregnancy.
c) Sexually active fertile men not willing to use effective birth control if their partners are WOCBP

6) Prohibited Treatments and/or Therapies
a) See Section 3.4.1 of the protocol (Prohibited and/or Restricted
Treatments) for therapies which are prohibited at study entry
b) Patients previously included or currently enrolled in clinical trials of apixaban
c) Required treatment with ASA > 165 mg/day
d) Simultaneous treatment with a thienopyridine (e.g., clopidogrel,
ticlopidine; see Section 3.4.2.1, Acetylsalicylic acid [ASA] and
Thienopyridines) or prasugrel or ticagrelor
e) Patients receiving rivaroxaban, dabigatran, or apixaban
f) Planned major surgery or/and invasive procedure
g) Planned atrial fibrillation or flutter ablation procedure
h) Planned cardioversion

7) Other Exclusion Criteria
a) Prisoners or subjects who are involuntarily incarcerated
b) Subjects who are compulsorily detained for treatment of either a psychiatric or physical (eg, infectious disease) illness
c) Use of an unapproved, investigational drug or device within the past 30 days or prior particip

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified