None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Rivaroxaban, in 15 mg and 20 mg tablets, at a dose of 20 mg, PO, QD + Warfarin Placebo, in 1 mg, 2.5 mg and 5 mg tablets, PO, QD, entitled to achieve a simulated INR of 2.5. This scheme will continue until 405 primary efficacy events are reached.
Group name:GROUP 2 Type of group
This group will be treated with Rivaroxaban Placebo, in 15 mg and 20 mg tablets, 1 tab, PO, QD + Warfarin, in 1 mg, 2.5 mg and 5 mg tablets, PO, QD, entitled to achieve a simulated INR 2.5. This scheme will continue until 405 primary efficacy events are reached.
Sponsors
BAYER S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men or women ≥18 years of age. 2. Non-valvular atrial fibrillation documented on at least 2 occasions, the first must be 1 to 6 months before the screening visit and the second within 14 days prior to randomization 3. History of ischemic stroke, TIA or systemic embolism outside the CNS considered of cardioembolic origin or with 2 or more risk factors. 3. Women should be postmenopausal, sterile by surgical procedures, abstinent or, if sexually active, use an effective contraceptive method before entering the study and throughout it. 4. Patients must have signed an informed consent stating that they understand the purpose of the study and the procedures it requires, and that they are willing to participate in the study. 5. To participate in the optional pharmacogenetic component, patients must have signed the informed consent document.
Exclusion criteria
Exclusion criteria: 1. Hemodynamically significant mitral valve stenosis. 2. Heart valve prosthesis. 3. Planned cardioversion. 4. Transient atrial fibrillation caused by a reversible disorder. 5. Knowledge of the presence of atrial myxoma or left ventricular thrombus. 6. Active endocarditis. 7. Active internal bleeding. 8. History of or condition associated with an increased risk of bleeding. 9. Planned invasive procedure with the possibility of uncontrolled bleeding. 10. Platelet count 3 x ULN.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of any cerebrovascular and / or embolic event that does not affect the CNS and its appropriate confirmation with images. Measure:Combined variable of stroke and systemic embolism outside the CNS. Timepoints:When the event occurs. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation of any cerebrovascular event, embolic that does not affect the CNS or death of vascular cause and its appropriate confirmation with images and laboratory tests. Measure:Secondary efficacy: 1) Combined variable of stroke, systemic embolism outside the CNS and vascular death. 2) Combined variable of stroke, systemic embolism outside the CNS, myocardial infarction and vascular death. Timepoints:When the event occurs. ; Outcome name:Criterion 1: Clinical evaluation of any cerebrovascular event, embolic that does not affect the CNS or death of vascular cause and its appropriate confirmation with images and laboratory tests. Criterion 2: Clinical evaluation of any disabling cerebrovascular event, defined as a modified Rankin scale score and its appropriate confirmation with images. Criterion 3: time from the start of treatment to death for any reason. Measure:Other efficacy criteria: 1) Individual components of the primary and secondary main combined variables. 2) Disabling stroke. 3) Mortality from all causes. Timepoints:When the event occurs. ; Outcome name:1) Health economics: Hospitalization data will be evaluated (total length of stay in days, days in the ICU / CCU), visits to the emergency room, unscheduled outpatient visits or visits related to bleeding, surgeries, other procedures selected (with hospitalization and outpatient) and post stroke care (level of care at 3 months of follow-up, at home or in a rehabilitation center or long-term care). 2) Satisfaction: Scale of anticoagulant treatment (ACTS), which is a questionnaire of 17 questions, each of which will be rated from 1 to 5. Measure:Health economics and patient satisfaction. Timepoints:Weeks 4, 8, 12 and 24. ; Outcome name:Genotyping of: 1) Genes involved in absorption, distribution, metabolism and excretion. 2) Genes involved in coagulation, thrombotic diseases and therapeutic responses. 3) Genes involved | — |
Countries
Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Korea South, Lithuania, Malasya, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kindgdom, United States, Venezuela
Outcome results
None listed