Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048
Condition: Atrial Fibrillation; Stroke
MeSH terms: Atrial Fibrillation
Intervention: dabigatran etexilate; dabigatran etexilate; dabigatran etexilate; dabigatran etexilate
Intervention description: dosage used at study start; dosage used at study start; dosage used at study start; dosage used at study start
Intervention MeSH terms: Dabigatran
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Masking: None (Open Label)
Enrollment: 361.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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] <= 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).