Patients with Non-Valvular Atrial Fibrillation with at least one risk factor for stroke and indicated for oral anticoagulant. MedDRA version: 16.0 Level: PT Classification code 10003658 Term: Atrial fibrillation System Organ Class: 10007541 - Cardiac disorders
Conditions
Sponsors
Bristol-Myers Squibb International Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Signed Written Informed Consent. - Patients with diagnosed non-valvular AF (documented by 12-lead ECG or 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. Patients treated with VKA should have received the VKA treatment for = 6 months. VKA naïve patients should not have received VKA treatment for more than 30 days within the last 12 months. - Patients previously treated with ASA for stroke prevention are allowed (and will switch to Apixaban). - Subject Re-enrollment: This study does not permit the re-enrollment of a subject 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 4. - 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. - 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
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 d) Planned atrial fibrillation ablation procedure to be performed during study period. 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 or spinal injury or intracranial haemorrhage •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 in all patients; any patient with a calculated creatinine clearance 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 165 mg/day c) Simultaneous treatment with a thienopyridine (e.g., clopidogrel, ticlopidine; see Section 3.4.2.1, Acetylsalicylic acid [ASA] and Thienopyridines) or prasugrel or ticagrelor d) Planned major surgery or/and invasive procedure e) Planned atrial fibrillation or flutter ablation procedure 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 participation into an apixaban clinical study d) Inability to comply with protocol visi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the impact of educational programme on implementation phase adherence in patients taking apixaban for SPAF at 24 weeks.;Secondary Objective: - To identify predictive risk factors linked to non-adherence in patients treated with apixaban. - To compare implementation phase adherence to apixaban treatment with secondary SOC versus (1) primary SOC and (2) continued additional educational program. - To compare implementation phase adherence to apixaban treatment at 12 weeks vs 24 weeks within groups. - To evaluate impact of educational programme on safety profile of apixaban. ;Primary end point(s): The primary endpoint for this study is the percentage of days with a correct execution of the apixaban dosing regimen during 24 weeks. This endpoint will be compared between the two study groups: Standard Of Care (SOC) information or additional education.;Timepoint(s) of evaluation of this end point: At 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - 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. - Adherence to apixaban dosing regimen during the 24 to 48 weeks in continued additional education group, secondary SOC group, and primary SOC group. - Risk factors indicative of non-adherence at 24 and 48 weeks. - Serious adverse events and other AEs, including major bleeding (ISTH);Timepoint(s) of evaluation of this end point: At 24 and 48 weeks | — |
Countries
Belgium, Germany, Italy, Spain, United Kingdom
Contacts
Public ContactEu Study Start-Up Unit
Bristol-Myers Squibb International Corporation
Outcome results
None listed