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-LY

Boehringer Ingelheim Ltd.0 sites18,000 target enrollmentFebruary 28, 2006

Overview

No summary available.

Registry

who.int

Start Date

February 28, 2006

End Date

March 15, 2009

Last Updated

6 years ago

Study Type

Interventional clinical trial of medicinal product

Sponsor

•Patients are eligible for this study if they meet the following criteria:
•1\.)AF documented by one of the following:
•a.There is ECG documented AF within one week of screening or randomization
•b.The patient has had a symptomatic episode of paroxysmal or persistent AF documented by 12 lead ECG within six months prior to randomization
•c.There is documentation of symptomatic or asymptomatic paroxysmal or persistent AF on two separate occasions, at least one day apart, one of which is within six months prior to randomization. In this case, AF may be documented by 12 lead ECG, rhythm strip, pacemaker/ICD electrogram, or Holter ECG. The duration of AF should be at least 30 seconds (documented in the medical record). Electrograms (not marker channels or mode switch episodes) from pacemakers and defibrillators can be used to document only one episode of paroxysmal or persistent AF
•2\.)In addition to documented AF, patients must have one of the following additional risk factors for stroke:
•a.History of previous stroke, transient ischemic attack, or systemic embolism
•b.Left ventricular ejection fraction \<40% documented by echocardiogram, radionuclide or contrast angiogram in the last 6 months
•c.Symptomatic heart failure, documented to be NYHA Class 2 or greater in the last 6 months
•d.Age \= 75 years

•1\.)PAtients with prosthetic heart valves requiring anticoagulation per se, or with haemodynamically relevant valve disease that is expected to require surgical intervention during the coarse of the study
•2\.)Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days
•3\.)Conditions associated with an increased risk of bleeding:
•4\.)Contraindication to warfarin treatment
•5\.)Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism).
•6\.)Plan to perform a pulmonary vein ablation or surgery for cure of the AF
•7\.)Severe renal impairment (estimated creatinine clearance \=30 mL/min)
•8\.)Active infective endocarditis
•9\.)Active liver disease, including but not limited to
•a.Persistent ALT, AST, Alk. Phos. \>2 x ULN