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

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 4

Conditions: Non-valvular Atrial Fibrillation

Treatments: Drug: Apixaban

Study type: Interventional

Funder types: Industry

Identifiers

NCT01884350

2013-000055-41 (EudraCT Number)

CV185-220

Details and patient eligibility

About

The study purpose is to assess the impact of an educational program on patient adherence in patients taking Apixaban for SPAF at 24 weeks

Full 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

Enrollment: 1,217 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,217 participants in 2 patient groups

Arm 1: Apixaban (Primary SOC information)

Experimental group

Description:

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

Treatment:

Drug: Apixaban

Arm 2: Apixaban (Additional Educational Program)

Experimental group

Description:

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

Treatment:

Drug: Apixaban