Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048

• Yearly Event Rate for Composite Endpoint of Stroke, Transient Ischaemic Attacks, System Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and Mortality. [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  Time to first occurrence of stroke, transient ischaemic attacks, system thromboembolism, myocardial infarction, other major adverse cardiac events and mortality. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
• Yearly Event Rate for Major Bleeding [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]

  Time to first occurrence of fatal or life-threatening, retroperitoneal, intracranial, intraocular, or intraspinal bleeding, which required surgical treatment, led to a transfusion of a minimum of 2 units of packed cells or whole blood, or led to a fall in hemoglobin of 20g/L or less.

  Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

• Yearly Event Rate for Major + Minor/Relevant Bleeding [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
  Time to first occurrence of either major or minor/relevant bleeding. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
• Yearly Event Rate for Any Bleeding [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
  Time to first occurrence of any bleeding event. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

• A composite clinical endpoint including the incidence of stroke (fatal + non-fatal), TIAs, systemic thromboembolism, myocardial infarction (fatal + non-fatal), other major adverse cardiac events, and all-cause mortality.
• Primary efficacy endpoint:

• Yearly Event Rate for Stroke [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  Time to first occurrence of any fatal or non-fatal stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
• Yearly Event Rate of Ischaemic Stroke [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  Time to first occurrence of any ischaemic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
• Yearly Event Rate of Haemorrhagic Stroke [ Time Frame: 7 years ] [ Designated as safety issue: Yes ]
  Time to first occurrence of any haemorrhagic stroke. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
• Yearly Event Rate for Transient Ischaemic Attacks [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  Time to first occurrence of any transient ischaemic attacks. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
• Yearly Event Rate for Systemic Thromboembolism [ Time Frame: 7 years ] [ Designated as safety issue: No ]

  Time to first occurrence of any non-central nervous system systemic thromboembolism.

  Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

• Yearly Event Rate of Myocardial Infarction [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  Time to first occurrence of any myocardial infarction. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
• Yearly Event Rate of Other Major Adverse Cardiac Events [ Time Frame: 7 years ] [ Designated as safety issue: No ]
  Time to first occurrence of any other major adverse cardiac events. Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25
• Yearly Event Rate for Composite Secondary Endpoint of Ischaemic Stroke, Transient Ischaemic Attacks, Non-central Nervous System Systemic Thromboembolism, Myocardial Infarction, Other Major Adverse Cardiac Events and All-cause Mortality [ Time Frame: 7 years ] [ Designated as safety issue: No ]

  Time to first occurrence of ischaemic stroke, transient ischaemic attacks, non-central nervous system systemic thromboembolism, myocardial infarction, other major adverse cardiac events and all-cause mortality.

  Yearly event rate (%) = number of subjects with event / subject-years * 100. Subject years = sum (date of end of treatment - date of start of treatment) of all entered subjects / 365.25

• Net clinical cost as measured by the composite clinical endpoint of stroke/TIA/systemic thromboembolism/MI/death plus major bleeds
• The occurrence rates of stroke (fatal and non-fatal), transient ischemic attacks (TIAs), systemic thromboembolism

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).

• Atrial Fibrillation
• Stroke

• Experimental: dabigatran etexilate, 150 mg once daily
  dosage used at study start
  Intervention: Drug: dabigatran etexilate
• Experimental: dabigatran etexilate, 150 mg twice daily
  dosage used at study start
  Intervention: Drug: dabigatran etexilate
• Experimental: dabigatran etexilate, 300 mg once daily
  dosage used at study start
  Intervention: Drug: dabigatran etexilate
• Experimental: dabigatran etexilate, 300 mg twice daily
  dosage used at study start
  Intervention: Drug: dabigatran etexilate

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] <= 30 mL/min). uncontrolled hypertension (systolic blood pressure [SBP] > 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).