Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)
Condition: Non-valvular Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Intervention: Apixaban
Intervention MeSH terms: Apixaban
Phase: Phase 4
Study type: Interventional
Primary purpose: Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 1217.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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
    

Eligibility criteria:

        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