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

Conditions: Prevention of Stroke and Systemic Embolism in patients with Atrial Fibrillation

Registration Number: EUCTR2005-003894-26-AT

Lead Sponsor: Boehringer Ingelheim Austria GmbH

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 15000

Inclusion Criteria

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
e.Age = 65 years and one of the following additional risk factors:
i)diabetes mellitus on treatment
ii)documented coronary artery disease (any of: prior MI, positive stress exercise test, positive nuclear perfusion study, prior CABG surgery or PCI, angiogram showing =75% stenosis in a major coronary artery
iii)hypertension requiring medical treatment
3.)Age =18 years at entry
4.)Written, informed consent.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

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
b.Known active hepatitis C (as evidenced by positive HCV RNA by sensitive PCR based assay, such as Roche Monitor or Bayer TMA assay)
c.Active hepatitis B (HBs antigen +, anti HBc IgM+)
d.Active hepatitis A
10.)Women who are pregnant or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study (NOTE: A negative pregnancy test must be obtained for any woman of childbearing potential prior to entry into the study)
11.)Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 10^9/L)
12.)Patients who have developed transaminase elevations upon exposure to ximelagatran.
13.)Patients who have received an investigational drug in the past 30 days
14.)Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse).