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 sites0 target enrollmentDecember 4, 2006

Overview

No summary available.

Registry

who.int

Start Date

December 4, 2006

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional

Sponsor

•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.

•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.

Not specified