EUCTR2014-001231-36-BE进行中（未招募）1 期
A phase IV trial to assess the effectiveness of Apixaban compared with usual care anticoagulation in subjects with non-valvular Atrial Fibrillation undergoing cardioversion - EMANATE
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Subjects with non-valvular atrial fibrillation (as documented by electrocardiogram (ECG at Visit 1) indicated for cardioversion and initiation of anticoagulation in accordance with the approved local label.
- •subjects presenting wiht atrial flutter with no evidence of atrial fibrillation are not eligible for enrolment.
- •2.Age =18 years (Age = 19 years for Korea only and Age = 20 years for Japan only).
- •3.Evidence of a personally signed and dated informed consent document indicating that the subject (or their legally-recognized representative) has been informed of all pertinent aspects of the study.
- •4.The subject is willing to provide contact details for at least one alternate person for study staff to contact regarding their whereabouts, should the subject be lost-to-follow-up over the course of the study.
- •5.Female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 28 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
- •6.Subjects who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
- •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 450
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1050
排除标准
- •1.Subjects having taken more than 48 hours of an anticoagulant (oral and/ or parenteral) immediatly prior to randomization.
- •2.Contraindications to apixaban or usual care (eg, VKA) in accordance with the approved local label.
- •3.Severe haemodynamically compromised subjects requiring emergent cardioversion.
- •4.Patients with hemodynamically significant mitral stenosis, mechanical or biological prosthetic valve or valve repair.
- •5.Conditions other than atrial fibrillation that require chronic anticoagulation (eg, a prosthetic mechanical heart valve).
- •6. Simultaneous treatment with both aspririn and thienopyridine (e.g., clopidogrel, ticlopidine, prasugrel or simultaneous treatment with both aspirin and ticagrelor).
- •7.Pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for at least 28 days after last dose of investigational product.
- •8.Participation in other studies involving investigational drug(s) (Phases 1-4) within 30 days before the current study begins and/or during study participation. Note: Subjects cannot be randomized into this study more than once.
- •9.Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.
- •10.Subjects who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or subjects who are BMS/Pfizer employees directly involved in the conduct of the trial.
研究者
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