Randomized Evaluation of Long Term Anticoagulant Therapy, Comparing the Efficacy and Safety of Two Blinded Doses of Dabigatran Etexilate With Open Label Warfarin for the Prevention of Stroke and Systemic Embolism in Patients With Non-valvular Atrial Fibrillation: Prospective, Multi-centre, Parallel-group, Non-inferiority Trial (RE-LY Study)

BOEHRINGER INGELHEIM PHARMA,0 个研究点目标入组 0 人开始时间: 2006年12月4日最近更新: 2023年9月4日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方: BOEHRINGER INGELHEIM PHARMA,

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional

入排标准

年龄范围: 0 至 0（—）

入选标准

•1) Documented Atrial fibrillation (AF).
•2) In addition to documented AF, patients must present one of the following additional risk factors for stroke: a) History of stroke, transient ischemic attack or systemic embolism. b) Left ventricular ejection fraction <40%. c) Symptomatic heart failure, documented as NYHA Class 2 or higher. d) Age ≥ 75 years. e) Age ≥ 65 years and one of the following additional risk factors: Diabetes mellitus in treatment. OR, Coronary disease documented. OR, Hypertension that requires medical treatment.
•3) Age ≥ 18 years at admission.
•4) Written informed consent.

排除标准

•1) History of cardiac valvular disorders.
•2) Severe, disabling stroke in the last 6 months or any stroke in the last 14 days.
•3) Conditions associated with increased risk of bleeding: a) Major surgery in the last month. b) Surgery or intervention planned in the next 3 months. c) History of intracranial, intraocular, spinal, retroperitoneal or non-traumatic intra-articular bleeding. d) Gastrointestinal bleeding in the last year. e) Gastroduodenal ulcerative disease symptomatically or endoscopically documented in the last 30 days. f) Haemorrhagic disorder or hemorrhagic diathesis. g) Need for anticoagulant treatment for other disorders other than atrial fibrillation. h) Fibrinolytic agents in the 48 hours before entering the study. i) Uncontrolled hypertension. j) Recent malignancy or radiotherapy and with expectation of
•survival less than 3 years.
•4) Contraindication for treatment with warfarin.
•5) Reversible causes of atrial fibrillation.
•6) Plan to perform pulmonary vein ablation or surgery for the healing of AF.
•7) Severe renal dysfunction.
•8) Active infectious endocarditis
•9) Active liver disease.
•10) Pregnant or fertile women who refuse to use a medically acceptable method of contraception during the entire study.
•11) Anemia or thrombocytopenia.
•12) Patients who presented elevations of transaminases when exposed to ximelagatran.
•13) Patients who received an experimental medication in the last 30 days.
•14) Patients that the researcher considers unreliable in terms of follow-up during the study and / or compliance with the administration of the study medication, with a life expectancy shorter than the estimated duration of the study due to concomitant or presenting diseases. Any condition will not allow safe participation in the study.

研究者

发起方

BOEHRINGER INGELHEIM PHARMA,

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Randomized Evaluation of Long term anticoagulant therapy (RE-LY) comparing the efficacy and safety of two blinded doses of dabigatran etexilate with open label warfarin for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation: prospective, multi-centre, parallel-group, non-inferiority trial (RE-LY STUDY) - RE-LYPrevention of Stroke and Systemic Embolism in patients with Atrial Fibrillation

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