The purposes of this study are: 1. To evaluate the long-term safety of dabigatran etexilate 2. To assess the effect of a knowledge translation intervention on patient outcomes
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
5,897
dabigatran high dose twice daily
dabigatran low dose twice daily
Major Bleeding, Annualized Rate of Subjects With Major Bleeds
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Major bleeding must have satisfied one or more of the following criteria: * Bleeding associated with a reduction in hemoglobin of at least 20 g/L * Required transfusion of at least 2 units of blood or packed cells * Symptomatic bleeding in a critical area or organ: intraocular, intraspinal, intramuscular with compartment syndrome, retroperitoneal, intra-articular, pericardial, gastrointestinal Major bleed were classified as life-threatening if they met one or more of the following criteria: * Reduction in hemoglobin of at least 50 g/L * Transfusion of at least 4 units of blood or packed cells * Symptomatic intracranial bleeding, either subdural or intracerebral * Associated with hypotension requiring use of intravenous inotropic agents * Required surgical intervention to stop bleeding * Resulted in death
Time frame: up to 43 months
Stroke, Annualized Rate of Subjects With Stroke
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Stroke was an acute onset of a focal neurological deficit of presumed vascular origin lasting for 24 hours or more or resulting in death. The stroke was categorized as ischemic or hemorrhagic or cause unknown based on computerized tomography (CT), magnetic resonance (MR) scanning or autopsy. Fatal stroke was defined as death from any cause within 30 days of stroke. Severity of stroke was assessed by modified Rankin score at discharge from hospital
Time frame: up to 43 months
Non CNS Systemic Embolism (SEE), Annualized Rate of Subjects With Non-CNS SEE
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Systemic embolism was an acute vascular occlusion of the extremities or any organ (kidneys, mesenteric arteries, spleen, retina or grafts), and was to be documented by angiography, surgery, scintigraphy, or autopsy.
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1160.71.0046 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1160.71.0057 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1160.71.0211 Boehringer Ingelheim Investigational Site
Birmingham, Alabama, United States
1160.71.0115 Boehringer Ingelheim Investigational Site
Mobile, Alabama, United States
1160.71.0104 Boehringer Ingelheim Investigational Site
Lake Havasu City, Arizona, United States
1160.71.0185 Boehringer Ingelheim Investigational Site
Tucson, Arizona, United States
1160.71.0038 Boehringer Ingelheim Investigational Site
Hot Springs, Arkansas, United States
1160.71.0302 Boehringer Ingelheim Investigational Site
Jonesboro, Arkansas, United States
1160.71.0191 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
1160.71.0213 Boehringer Ingelheim Investigational Site
Little Rock, Arkansas, United States
...and 557 more locations
Time frame: up to 43 months
Pulmonary Embolism (PE), Annualized Rate of Subjects With PE
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Pulmonary Embolism was generally documented by one of the following: 1. an intraluminal filling defect in segmental or more proximal branches on spiral CT scan 2. an intraluminal filling defect or an extension of an existing defect or a sudden cutoff of vessels more than 2.5 mm in diameter on the pulmonary angiogram 3. a perfusion defect of at least 75% of a segment with a local normal ventilation result (high-probability) on ventilation/perfusion lung scan (VPLS) 4. inconclusive spiral CT, pulmonary angiography or lung scintigraphy with demonstration of DVT in the lower extremities by compression ultrasound or venography.
Time frame: up to 43 months
Acute Myocardial Infarction (MI), Annualized Rate of Subjects With MI
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. a. In subjects not undergoing PCI or CABG a subject should have fulfilled at least 2 of the following: i. Typical prolonged severe chest pain or related symptoms or signs suggestive of MI. ii. Elevation of troponin or CK-MB to more than upper level of normal (ULN) or, if CK-MB was elevated at baseline, re-elevation to more than 50% increase above the previous level. iii. Development of significant Q-waves in at least 2 adjacent ECG leads. b. After percutaneous coronary intervention (within 24h). c. After coronary artery bypass grafting (within 72h). d. Silent myocardial infarction. e. Myocardial infarction could also have been demonstrated at autopsy.
Time frame: up to 43 months
Deep Vein Thrombosis, Annualized Rate of Subjects With DVT
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deep Vein Thrombosis (DVT) was generally documented by one of the following: 1. abnormal compression ultrasound (CUS), 2. an intraluminal filling defect on venography.
Time frame: up to 43 months
Death, Annualized Rate of Subject Death
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Deaths were classified as being vascular (sudden/arrhythmic, pump failure death, or other vascular, including bleeding) or non-vascular, due to other specified causes (e.g., malignancy), or of unknown etiology.
Time frame: up to 43 months
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE)
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE) and All Cause Death
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction, Vascular Death
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Composite Incidence of Stroke, Non CNS Systemic Embolism (SEE), Pulmonary Embolism (PE), Myocardial Infarction (MI), All Cause Death and Major Bleed
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Minor Bleeds
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25. Minor bleeds were clinical bleeds that did not fulfill the criteria for major bleeds. Minor bleeds were classified as associated with study medication discontinuation (temporary or permanent) or not.
Time frame: up to 43 months
Annualized Rate of Subjects With Any Bleeds (Major Plus Minor)
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months
Annualized Rate of Subjects With Intra-Cranial Hemorrhage (ICH)
Annualized event rate (%) = 100 \* No. subjects with event / subject-years. Subject-years = Sum (date of last visit - date of first dose + 1) of all subjects / 365.25.
Time frame: up to 43 months