New-Onset Post-Operative Atrial Fibrillation after CABG
Conditions
Brief summary
Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE)), Primary safety endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5
Detailed description
Composite of death, ischemic stroke, TIA, MI, or systemic arterial thromboembolism, Net clinical benefit (NCB), Incidence of the primary effectiveness and safety endpoints at 180 days after randomization, Individual components of the primary effectiveness and safety endpoints at 90 d and 180 days after randomization, Cardiovascular and non-cardiovascular mortality at 90 and180 days after randomization, Incidence of BARC 2 bleeding at 90 and 180 days after randomization, Cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention at 90 and 180 days after randomization, Length of stay of index hospitalization, Number and reasons for readmissions at 90 and 180 days after rendomization, Hospital resource utilization at 180 days after surgey, Patients' convenience and satisfaction survey utilizing the Perception of Anticoagulation Treatment Questionnaire (PACT-Q2) at 90 days after randomization
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary effectiveness endpoint: composite of death, ischemic stroke, transient ischemic attack (TIA), myocardial infarction (MI), systemic arterial thromboembolism or venous thromboembolism (VTE) (deep venous thrombosis (DVT) and/or pulmonary embolism (PE)), Primary safety endpoint: Bleeding Academic Research Consortium (BARC) type 3 or 5 | — |
Secondary
| Measure | Time frame |
|---|---|
| Composite of death, ischemic stroke, TIA, MI, or systemic arterial thromboembolism, Net clinical benefit (NCB), Incidence of the primary effectiveness and safety endpoints at 180 days after randomization, Individual components of the primary effectiveness and safety endpoints at 90 d and 180 days after randomization, Cardiovascular and non-cardiovascular mortality at 90 and180 days after randomization, Incidence of BARC 2 bleeding at 90 and 180 days after randomization, Cardiac arrhythmias including recurrent symptomatic or asymptomatic AF requiring medical attention at 90 and 180 days after randomization, Length of stay of index hospitalization, Number and reasons for readmissions at 90 and 180 days after rendomization, Hospital resource utilization at 180 days after surgey, Patients' convenience and satisfaction survey utilizing the Perception of Anticoagulation Treatment Questionnaire (PACT-Q2) at 90 days after randomization | — |
Countries
Germany