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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Bristol-Myers Squibb
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01884350
First received: June 13, 2013
Last updated: July 23, 2014
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Non-valvular Atrial Fibrillation
Drug: Apixaban
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Assessment of an Education and Guidance Programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation (AEGEAN)

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Percentage of days with a correct execution of the Apixaban dosing regimen during 24 weeks [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
    This endpoint will be compared between the two study groups: Standard of care (SOC) information or additional education


Secondary Outcome Measures:
  • Within each study group, 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 [ Time Frame: Up to week 24 ] [ Designated as safety issue: No ]
  • Adherence to Apixaban dosing regimen during the 24 to 48 weeks in continued additional education group, secondary SOC group, and primary SOC group [ Time Frame: Up to week 48 ] [ Designated as safety issue: No ]
  • Risk factors indicative of non-adherence at 24 and 48 weeks [ Time Frame: Up to Week 48 ] [ Designated as safety issue: No ]
    Within each group, a linear regression approach will be used to identify predictors of non-adherence within baseline characteristics. Possible predictors include Mini-Mental State Examination (MMSE) scores, age, number of concomitant medications, ethnicity, United Kingdom (UK) standard occupational classification, and previous experience with vitamin K antagonists [VKA] (Yes versus No)

  • Incidence of serious adverse events (AEs) and other AEs, including major bleeding (ISTH) [ Time Frame: Up to week 48 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1112
Study Start Date: October 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1: Apixaban (Primary SOC information)
Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Primary SOC information
Drug: Apixaban
Other Names:
  • Eliquis
  • BMS-562247
Experimental: Arm 2: Apixaban (Additional Educational Program)
Apixaban 2.5 mg or 5 mg by mouth twice daily for 48 weeks and Additional Educational Program
Drug: Apixaban
Other Names:
  • Eliquis
  • BMS-562247

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01884350

Contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information, please email: Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT# and Site #.

  Show 142 Study Locations
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01884350     History of Changes
Other Study ID Numbers: CV185-220, 2013-000055-41
Study First Received: June 13, 2013
Last Updated: July 23, 2014
Health Authority: European Union: European Medicines Agency

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014