Randomized Evaluation of Long Term Anticoagulant Therapy (RE-LY) With Dabigatran Etexilate
Atrial Fibrillation, Stroke
About this trial
This is an interventional prevention trial for Atrial Fibrillation
Eligibility Criteria
Inclusion criteria Patients with non-valvular atrial fibrillation (AF), at moderate to high risk of stroke, or systemic embolism with at least one additional risk factor (i.e. previous ischemic stroke, TIA, or systemic embolism, left ventricular dysfunction, age >=75 years, age >=65 with either diabetes mellitus, history of coronary artery disease or hypertension) Exclusion criteria Prosthetic heart valves requiring anticoagulation per se, or hemodynamically relevant valve disease that is expected to require surgical intervention during the course of the study Severe, disabling stroke within the previous 6 months, or any stroke within the previous 14 days Conditions associated with an increased risk of bleeding Contraindication to warfarin treatment Reversible causes of atrial fibrillation (e.g., cardiac surgery, pulmonary embolism, untreated hyperthyroidism). Plan to perform a pulmonary vein ablation or surgery for cure of the AF Severe renal impairment (estimated creatinine clearance <=30 mL/min) Active infective endocarditis Active liver disease Women who are pregnant, lactating, or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L) Patients who have developed transaminase elevations upon exposure to ximelagatran Patients who have received an investigational drug in the past 30 days or are participating in another drug study Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration, has a life expectancy less than the expected duration of the trial due to concomitant disease, or has any condition which in the opinion of the investigator, would not allow safe participation in the study (e.g., drug addiction, alcohol abuse) Any known hypersensitivity to galactose if the warfarin used contains galactose.
Sites / Locations
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- 1160.26.0671 Clinical Research & Diagnostic Solutions Inc.
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- 1160.26.0966 Boehringer Ingelheim Investigational Site
- 1160.26.0908 University Hospital of Alexandroupolis
- 1160.26.0901 General Hospital "Alexandra", Therapeutic Clinic UOA
- 1160.26.0906 General Hospital ";Evangelismos"
- 1160.26.0907 "Pammakaristos" Hospital of Athens
- 1160.26.0915 "Hippokratio" Hospital of Athens
- 1160.26.0914 2nd IKA Hospital, Thessaloniki
- 1160.26.0904 General Hospital of Larissa
- 1160.26.0913 University Hospital of Larissa
- 1160.26.0912 General Hospital of Leivadia
- 1160.26.0902 General Hospital " Papageorgiou"
- 1160.26.0910 General Hospital of Thiva
- 1160.26.0903 General Hospital of Trikala
- 1160.26.0905 Boehringer Ingelheim Investigational Site
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- 1160.26.1293 Boehringer Ingelheim Investigational Site
- 1160.26.1295 Boehringer Ingelheim Investigational Site
- 1160.26.1296 Boehringer Ingelheim Investigational Site
- 1160.26.1318 Hospital General "Dr. Santiago Ramón y Cajal
- 1160.26.1311 Hospital Mexico-Americano
- 1160.26.1317 hOSPITAL bERNARDETTE
- 1160.26.1312 Hospital de Jesus
- 1160.26.1319 Instituto Nacional de Cardiologia
- 1160.26.1314 Hospital 1o. de Octubre
- 1160.26.1313 Hosp. Angeles Centro Medico del Potosi
- 1160.26.1322 Hospital Central "Dr. Ignacio Morones Prieto"
- 1160.26.1344 Boehringer Ingelheim Investigational Site
- 1160.26.1331 Boehringer Ingelheim Investigational Site
- 1160.26.1336 Boehringer Ingelheim Investigational Site
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- 1160.26.1397 Boehringer Ingelheim Investigational Site
- 1160.26.1394 Boehringer Ingelheim Investigational Site
- 1160.26.1415 Hospital Alberto Sabogal
- 1160.26.1411 Clinica San Felipe
- 1160.26.1412 Clínica Anglo Americana
- 1160.26.1413 Hospital Cayetano Heredia
- 1160.26.1414 Clínica Vesalio
- 1160.26.1421 Philippine General Hospital
- 1160.26.1422 Manila Doctors Hospital
- 1160.26.1424 The Medical City
- 1160.26.1423 Philippine Heart Center
- 1160.26.1425 St Lukes Medical Center
- 1160.26.1437 Boehringer Ingelheim Investigational Site
- 1160.26.1436 Boehringer Ingelheim Investigational Site
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- 1160.26.1512 Boehringer Ingelheim Investigational Site
- 1160.26.1513 Boehringer Ingelheim Investigational Site
- 1160.26.1514 Boehringer Ingelheim Investigational Site
- 1160.26.1515 Boehringer Ingelheim Investigational Site
- 1160.26.1531 Boehringer Ingelheim Investigational Site
- 1160.26.1532 Boehringer Ingelheim Investigational Site
- 1160.26.1548 Boehringer Ingelheim Investigational Site
- 1160.26.1541 Boehringer Ingelheim Investigational Site
- 1160.26.1542 Boehringer Ingelheim Investigational Site
- 1160.26.1543 Boehringer Ingelheim Investigational Site
- 1160.26.1544 Boehringer Ingelheim Investigational Site
- 1160.26.1545 Boehringer Ingelheim Investigational Site
- 1160.26.1546 Boehringer Ingelheim Investigational Site
- 1160.26.1549 Boehringer Ingelheim Investigational Site
- 1160.26.1550 Boehringer Ingelheim Investigational Site
- 1160.26.1547 Boehringer Ingelheim Investigational Site
- 1160.26.1562 Boehringer Ingelheim Investigational Site
- 1160.26.1569 Boehringer Ingelheim Investigational Site
- 1160.26.1561 Boehringer Ingelheim Investigational Site
- 1160.26.1564 Boehringer Ingelheim Investigational Site
- 1160.26.1567 Boehringer Ingelheim Investigational Site
- 1160.26.1568 Boehringer Ingelheim Investigational Site
- 1160.26.1566 Boehringer Ingelheim Investigational Site
- 1160.26.1563 Boehringer Ingelheim Investigational Site
- 1160.26.1565 Boehringer Ingelheim Investigational Site
- 1160.26.1601 Boehringer Ingelheim Investigational Site
- 1160.26.1606 Boehringer Ingelheim Investigational Site
- 1160.26.1607 Boehringer Ingelheim Investigational Site
- 1160.26.1604 Boehringer Ingelheim Investigational Site
- 1160.26.1609 Boehringer Ingelheim Investigational Site
- 1160.26.1603 Boehringer Ingelheim Investigational Site
- 1160.26.1608 Boehringer Ingelheim Investigational Site
- 1160.26.1605 Boehringer Ingelheim Investigational Site
- 1160.26.1602 Boehringer Ingelheim Investigational Site
- 1160.26.1633 Sahlgrenska Sjukhuset
- 1160.26.1629 AVK-mott, Spec.M1, Länssjukhuset Ryhov
- 1160.26.1631 Universitetssjukhuset i Linköping
- 1160.26.1627 Hjärtmott. ING 35, Malmö Universitetssjukhus MAS
- 1160.26.1625 Hjärtmott./Medicinkliniken, Vrinnevisjukhuset
- 1160.26.1628 Rådhusg. 29, Lars Mörlids Läkarmottagning
- 1160.26.1626 Hjärtkärllaboratoriet, Danderyds Sjukhus AB
- 1160.26.1632 Capio S:t Görans Sjukhus
- 1160.26.1634 Södersjukhuset
- 1160.26.1624 Klin. forskningscentrum, Norrlands Universitetssjukhus
- 1160.26.1621 Kardiologiska kliniken, Akademiska Sjukhuset
- 1160.26.1635 UCR/Uppsala
- 1160.26.1622 Hjärtmottagningen, Centrallasarettet
- 1160.26.1623 Kardiologiska kliniken, Universitetssjukhuset
- 1160.26.1652 Boehringer Ingelheim Investigational Site
- 1160.26.1655 Boehringer Ingelheim Investigational Site
- 1160.26.1651 Boehringer Ingelheim Investigational Site
- 1160.26.1654 Boehringer Ingelheim Investigational Site
- 1160.26.1680 Boehringer Ingelheim Investigational Site
- 1160.26.1683 Boehringer Ingelheim Investigational Site
- 1160.26.1682 Boehringer Ingelheim Investigational Site
- 1160.26.1679 China Medical University Hospital
- 1160.26.1681 Boehringer Ingelheim Investigational Site
- 1160.26.1671 Boehringer Ingelheim Investigational Site
- 1160.26.1672 Boehringer Ingelheim Investigational Site
- 1160.26.1673 Boehringer Ingelheim Investigational Site
- 1160.26.1674 Boehringer Ingelheim Investigational Site
- 1160.26.1675 Boehringer Ingelheim Investigational Site
- 1160.26.1676 Boehringer Ingelheim Investigational Site
- 1160.26.1677 Boehringer Ingelheim Investigational Site
- 1160.26.1678 Boehringer Ingelheim Investigational Site
- 1160.26.1701 Boehringer Ingelheim Investigational Site
- 1160.26.1702 Boehringer Ingelheim Investigational Site
- 1160.26.1703 Boehringer Ingelheim Investigational Site
- 1160.26.1704 Boehringer Ingelheim Investigational Site
- 1160.26.1705 Boehringer Ingelheim Investigational Site
- 1160.26.1715 Boehringer Ingelheim Investigational Site
- 1160.26.1711 Boehringer Ingelheim Investigational Site
- 1160.26.1713 Gazi Universitesi Tip Fakultesi Kardiyoloji Abd
- 1160.26.1714 Dokuz Eylul Universitesi Tip Fakultesi
- 1160.26.1727 Boehringer Ingelheim Investigational Site
- 1160.26.1726 Boehringer Ingelheim Investigational Site
- 1160.26.1724 Boehringer Ingelheim Investigational Site
- 1160.26.1725 Boehringer Ingelheim Investigational Site
- 1160.26.1721 Boehringer Ingelheim Investigational Site
- 1160.26.1722 Boehringer Ingelheim Investigational Site
- 1160.26.1723 Boehringer Ingelheim Investigational Site
- 1160.26.1728 Boehringer Ingelheim Investigational Site
- 1160.26.1730 Boehringer Ingelheim Investigational Site
- 1160.26.1731 Boehringer Ingelheim Investigational Site
- 1160.26.1729 Boehringer Ingelheim Investigational Site
- 1160.26.1744 Boehringer Ingelheim Investigational Site
- 1160.26.1746 Boehringer Ingelheim Investigational Site
- 1160.26.1747 Boehringer Ingelheim Investigational Site
- 1160.26.1750 Boehringer Ingelheim Investigational Site
- 1160.26.1753 Boehringer Ingelheim Investigational Site
- 1160.26.1755 Boehringer Ingelheim Investigational Site
- 1160.26.1749 Boehringer Ingelheim Investigational Site
- 1160.26.1741 Boehringer Ingelheim Investigational Site
- 1160.26.1756 Boehringer Ingelheim Investigational Site
- 1160.26.1742 Boehringer Ingelheim Investigational Site
- 1160.26.1751 Boehringer Ingelheim Investigational Site
- 1160.26.1752 Boehringer Ingelheim Investigational Site
- 1160.26.1745 Boehringer Ingelheim Investigational Site
- 1160.26.1743 Boehringer Ingelheim Investigational Site
- 1160.26.1754 Boehringer Ingelheim Investigational Site
- 1160.26.1748 Boehringer Ingelheim Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Active Comparator
Active Comparator
Dabigatran dose 2
Warfarin
Dabigatran dose 1
twice a day
once a day
twice a day