Health Condition 1: null- Atrial Fibrillation Health Condition 2: I489- Unspecified atrial fibrillation and atrial flutter
Conditions
Interventions
Intervention1: Dabigatran etexilate: 110mg or 150mg b.i.d. for up to 28 months
Control Intervention1: Nil: Nil
Sponsors
Boehringer Ingelheim Korea Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Patients are eligible for this study if they meet the following criteria: 1. Randomization to dabigatran in RE-LY and not permanently discontinued from dabigatran at the time of RE-LY termination visit 2. Patient must require long-term treatment with oral anticoagulation and investigator determines it is clinically appropriate for patient to continue receiving oral anticoagulation. 3. Written, informed consent
Exclusion criteria
Exclusion criteria: 1. Need for anticoagulant treatment for disorders other than atrial fibrillation 2. Plan to perform a pulmonary vein ablation or surgery for cure of AF 3. Patients with prosthetic heart valves requiring anticoagulation differing from an INR of 2.0?3.0 4. Symptomatic or endoscopically documented gastroduodenal ulcer disease in the 30 days prior to the start of this trial 5. Severe renal impairment (estimated creatinine clearance &#8804;30 mL/min) based upon last results available from RE-LY 1160.26 (should be from within the past year) 6. Anaemia (haemoglobin <100g/L) or thrombocytopenia (platelet count <100 x 109/L) based upon last results available from RE-LY 1160.26 (should be from within the past year). 7. Uncontrolled hypertension (SBP >180 mmHg and/or DBP >100 mmHg) 8. Active liver disease, including known hepatitis A, B or C 9. Active infective endocarditis 10. Women who are pregnant, lactating or of childbearing potential who refuse to use a medically acceptable form of contraception throughout the study 11. Patients who have received an investigational drug other than dabigatran in the past 30 days or are participating in another drug study. 12. Patients considered unreliable by the investigator concerning the requirements for follow-up during the study and/or compliance with study drug administration (i.e., demonstrated study drug compliance of less than 80% in RE-LY or was noncompliant with study visits in RE-LY), 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). 13. Current use of quinidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Knowledge translation: Primary endpoints: Vascular death, stroke, myocardial infarction, non- non-CNS systemic embolism, major bleeding and hospitalization for heart failure. Timepoint: Maximum 28 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints: Stroke (including hemorrhagic), non-CNS systemic embolism, pulmonary embolism, acute MI, DVT, and all deaths (includes deaths from bleeding) Timepoint: Maximum 28 months | — |
Countries
Canada, India, Republic of Korea
Contacts
Public ContactSuchela Srivatsa
IQVIA RDS (India) Private Limited
Outcome results
None listed