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 Pharma GmbH & Co. KG0 sites15,000 target enrollmentMarch 16, 2006

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Prevention of Stroke and Systemic Embolism in patients with Atrial Fibrillation
Sponsor: Boehringer Ingelheim Pharma GmbH & Co. KG
Enrollment: 15000
Status: Active, not recruiting
Last Updated: 14 years ago

No summary available.

Registry

who.int

Start Date

March 16, 2006

End Date

TBD

Last Updated

14 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•Patients are eligible for this study if they meet the following criteria:
•1\.)AF documented as follows:
•a.There is ECG documented AF on the day 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. 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
•c.Symptomatic heart failure, documented to be NYHA Class 2 or greater
•d.Age \= 75 years

•1\.)History of heart valve disorders (i.e., prosthetic valve or hemodynamically relevant valve disease)
•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