PETRO Stroke Prevention in Patients With AF by Treatment With Dabigatran, With and Without Aspirin, Compared to Warfarin

Exclusion Criteria

• •1. Valvular heart disease.
• •2. Planned cardioversion.
• •3. Recent (=\< 1 month) myocardial infarction, stroke or transient ischemic attack (TIA), or patients who have received a coronary stent within the last 6 months.
• •4. Intolerance or contraindications to acetylsalicylic acid (ASA).
• •5. Any contraindication to anticoagulant therapy.
• •6. Major bleeding within the last 6 months (other than gastrointestinal (GI) hemorrhage).
• •7. Severe renal impairment (estimated glomerular filtration rate (GFR) =\< 30 mL/min).
• •8. Uncontrolled hypertension (SBP \> 180 mmHg and/or DBP \> 100 mmHg).
• •9. Abnormal liver function as defined by aspartat-aminotransferase (AST), alanin-aminotransferase (ALT), serum bilirubin or alkaline phosphatase (AP) above the reference range, or history of liver disease.
• •10. Women who are pregnant or of childbearing potential who refuses to use a medically acceptable form of contraception throughout the study.
• •11. Patients who have received an investigational drug within the last 30 days.
• •12. Patients scheduled for major surgery or invasive procedures which may cause bleeding, or those who have had major surgery or percutaneous coronary intervention (PCI) within 6 weeks.
• •13. Patients considered unreliable by the investigator.
• •14. Another indication for anticoagulant treatment.
• •15. Patients suffering from anemia.
• •16. Patients suffering from thrombocytopenia.
• •17. Any other condition which, in the discretion of the investigator, would not allow safe participation in the study.
• •18. Concomitant treatment with antiplatelet agents other than ASA.
• •19. Recent malignancy or radiation therapy (=\< 6 month).