long-term, open-label follow-up treatment of patients with a-fib who have been previously treated with bibr 1048

Conditions: Atrial Fibrillation; Stroke

Summary: to determine the long term safety and efficacy of bibr 1048 in patients with chronic atrial fibrilla tion, with or without concomitant chronic treatment with acetylsalicylic acid (asa).


Eligibility criteria:
inclusion criteria diagnosis and main criteria for inclusion: paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation with a history of coronary artery disease (cad) inclusion criteria: * previous treatment with bibr 1048 in petro (trial 1160.20- nct01227629) and no premature discontinuation of therapy * paroxysmal, persistent, or permanent (chronic) non-rheumatic atrial fibrillation, documented by electrocardiogram (ecg) at least twice prior to enrollment in petro * concomitant coronary artery disease -an additional risk factor for stroke (one or more of the following conditions/events): hypertension, diabetes mellitus (dm), congestive heart failure (chf) or left ventricular dysfunction (lvd), previous ischemic stroke or transient ischemic attack) tia, or age greater than 75 years. -age \>= 18 years * written, informed consent exclusion criteria exclusion criteria: * valvular heart disease conferring significantly increased risk of thromboembolic events (e.g. clinically significant mitral stenosis or prosthetic valves). planned cardioversion while patients are in the study. * contraindication to anticoagulant therapy (previous intracranial hemorrhage, gastro-intestinal (gi) hemorrhage within previous 3 months, previous severe hemorrhage with warfarin at therapeutic international normalized ratio (inr), regular use of non-steroidal anti-inflammatory drugs, hemorrhagic diathesis) major bleeding within the last 6 months (other than gi hemorrhage). * severe renal impairment (estimated glomerular filtration rate \[gfr\] \ 180 mm hg and/or diastolic blood pressure \[dbp\] \> 100 mmhg). * 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). * patients who have received an investigational drug other than bibr 1048 within the last 30 days. * patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration. another indication for anticoagulant treatment (eg, deep vein thrombosis or pulmonary embolus). clinically significant anemia (note: patients with mild-moderate anemia should only be enrolled after the possibility of a gi bleeding source has been evaluated, the etiology of the anemia identified, and appropriate action taken). patients suffering from thrombocytopenia (platelets \< 100,000/ul). any other condition which, in the discretion of the investigator, would not allow safe participation in the study. * continuing or planned concomitant treatment with antiplatelet agents other than acetylsalicylic acid (asa). * recent malignancy or radiation therapy (\<= 6 months).