This is a study of the long term safety of dabigatran (intended indication: stroke prevention in patients with atrial fibrillation).Eligible patients received dabigatran during the RE-LY trial 1160.26.At the time of entry into RE-LY, patients had at least one risk factor for stroke (1) congestive heart failure, 2) left ventricular dysfunction, 3) age >75, 4) age >65 years with hypertension, diabetes or coronary artery disease or 5) previous stroke, systemic embolism or transient ischemic attack)
Conditions
Sponsors
Boehringer Ingelheim AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Need for anticoagulant treatment for disorders other than atrial fibrillation 2. Plan to cure of AF 3. Patients with prosthetic heart valves 4. gastroduodenal ulcer disease 5. Severe renal impairment 6. Anaemia or thrombocytopenia 7. Uncontrolled hypertension 8. Active liver disease 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. Other reasons for which Investigator determines patient icannot safely participate 13. Current use of quinidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: This trial has two main objectives: 1. To evaluate the long-term safety of two doses of dabigatran. 2. To evaluate the efficacy of patient customized audit and feedback compared to general information on best practice to reduce cardiovascular outcomes. ;Secondary Objective: ;Primary end point(s): 1. Since the objective of this trial is safety, there are no primary efficacy endpoints related to the evaluation of dabigatran. Safety will primarily be determined by the occurrence of major bleeding. 2. The primary endpoint for knowledge translation component is the composite endpoint of vascular death, stroke, myocardial infarction (MI), non-CNS systemic embolism, major bleeding and hospitalization for heart failure. | — |
Countries
Austria, Belgium, Bulgaria, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Italy, Netherlands, Poland, Portugal, Slovakia, Sweden, United Kingdom
Outcome results
None listed