Assessment of an Education and Guidance programme for Eliquis Adherence in Non-Valvular Atrial Fibrillation. - AEGEA

Bristol-Myers Squibb0 个研究点目标入组 40 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

暂无简介。

•-Signed written informed consent
•-Patients (from18 years old) with diagnosed non-valvular AF and eligible for OAC therapy
•-Presence of at least one of the following risk factors for stroke: prior stroke or TIA, Age >74, hypertension, diabetes mellitus, symptomatic heart failure
•-must be able to self-administer treatment
•-Either VKA treated or VKA naive. VKA-treated patients must have received the VKA treatment for more than 3 months. VKA-naive patients must 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
•-Patients with screening Mini-mental state examination score (MMSE) more than 24 (out of 30).
•-Acceptable method of contraception/negative pregnancy test

•-Atrial fibrillation or flutter due to reversible causes
•-Clinically significant mitral stenosis
•-Cardiac valvular disease requiring surgery
•-Conditions other than AF that require chronic anticoalgulation (see also section 3.4. of the Protocol)
•-Patients with serious bleeding in the last 6 months or with lesion or high risk of bleeding
•-Persistent, uncontrolled hypertension
•-Active infective endocarditis
•-Hepatic disease associated with coagulopathy and clinically relevant bleeding risk
•-Active alcohol or drug abuse or psychological reason that makes the study participation impractical
•-Severe co-morbid condition with life expectancy < 1 year
•-Severe renal insuffiency calculated by Cockrof-Gault or undergoing dialysis
•-Allergy or adverse reaction to Apixaban
•-Women who are pregnant or breast feeding
•- Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling / unable to use acceptable method to avoid pregnancy (as per section 3.3.3. of the Protocol)
•as per section 3.3.2. 6) and 7)
•Prohibited and/or restricted treatments as per section 3.4.1. of the protocol

发起方

Bristol-Myers Squibb