Long-term, Open-label Follow-up Treatment of Patients With A-fib Who Have Been Previously Treated With BIBR 1048
Atrial Fibrillation, Stroke
About this trial
This is an interventional prevention trial for Atrial Fibrillation
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).
Sites / Locations
- 1160.42.10003 Boehringer Ingelheim Investigational Site
- 1160.42.10006 Boehringer Ingelheim Investigational Site
- 1160.42.10004 Boehringer Ingelheim Investigational Site
- 1160.42.10002 Boehringer Ingelheim Investigational Site
- 1160.42.10015 Boehringer Ingelheim Investigational Site
- 1160.42.10008 Boehringer Ingelheim Investigational Site
- 1160.42.10012 Boehringer Ingelheim Investigational Site
- 1160.42.10007 Boehringer Ingelheim Investigational Site
- 1160.42.10014 Boehringer Ingelheim Investigational Site
- 1160.42.10013 Boehringer Ingelheim Investigational Site
- 1160.42.10009 Boehringer Ingelheim Investigational Site
- 1160.42.10001 Boehringer Ingelheim Investigational Site
- 1160.42.45010 Boehringer Ingelheim Investigational Site
- 1160.42.45005 Boehringer Ingelheim Investigational Site
- 1160.42.45007 Boehringer Ingelheim Investigational Site
- 1160.42.45011 Boehringer Ingelheim Investigational Site
- 1160.42.45012 Boehringer Ingelheim Investigational Site
- 1160.42.45003 Boehringer Ingelheim Investigational Site
- 1160.42.45004 Boehringer Ingelheim Investigational Site
- 1160.42.45009 Boehringer Ingelheim Investigational Site
- 1160.42.45002 Boehringer Ingelheim Investigational Site
- 1160.42.45014 Boehringer Ingelheim Investigational Site
- 1160.42.45001 Boehringer Ingelheim Investigational Site
- 1160.42.45013 Roskilde Sygehus
- 1160.42.45006 Boehringer Ingelheim Investigational Site
- 1160.42.31003 Ziekenhuis Amstelveen
- 1160.42.31001 Academisch Medisch Centrum
- 1160.42.31013 Onze Lieve Vrouwe Gasthuis
- 1160.42.31008 Gelre Ziekenhuis, locatie Juliana
- 1160.42.31006 Wilhelmina Ziekenhuis
- 1160.42.31007 Gemini Ziekenhuis
- 1160.42.31002 Ziekenhuis Gelderse Vallei
- 1160.42.31014 Ziekenhuisgroep Twente
- 1160.42.31012 Vasculair onderzoekscentrum (VOC)
- 1160.42.31009 Havenziekenhuis
- 1160.42.31004 Maasland Ziekenhuis
- 1160.42.31005 Tweesteden Ziekenhuis
- 1160.42.31011 Maxima Medisch Centrum
- 1160.42.46013 Boehringer Ingelheim Investigational Site
- 1160.42.46007 Boehringer Ingelheim Investigational Site
- 1160.42.46005 Boehringer Ingelheim Investigational Site
- 1160.42.46010 Boehringer Ingelheim Investigational Site
- 1160.42.46009 Boehringer Ingelheim Investigational Site
- 1160.42.46008 Boehringer Ingelheim Investigational Site
- 1160.42.46002 Boehringer Ingelheim Investigational Site
- 1160.42.46011 Boehringer Ingelheim Investigational Site
- 1160.42.46006 Boehringer Ingelheim Investigational Site
- 1160.42.46001 Boehringer Ingelheim Investigational Site
- 1160.42.46003 Boehringer Ingelheim Investigational Site
- 1160.42.46004 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Experimental
dabigatran etexilate, 150 mg once daily
dabigatran etexilate, 150 mg twice daily
dabigatran etexilate, 300 mg once daily
dabigatran etexilate, 300 mg twice daily
dosage used at study start
dosage used at study start
dosage used at study start
dosage used at study start