acute pneumonia
Conditions
Brief summary
All-cause mortality at D90 after randomization
Detailed description
EFFICACY: All-cause mortality at D30 and D120, EFFICACY: CV mortality at D30, D90 and D120 (i.e. mortality related to major CV events*), EFFICACY: Occurrence of major CV events (composite endpoint including at least one of the following: *myocardial infarction, stroke, heart failure, new atrial fibrillation, pulmonary embolism, CV death, sudden death) within 30 days, 90 days and 120 days of randomization, EFFICACY: Number of days in intensive care or resuscitation unit within 30 days and 90 days of randomization, EFFICACY: Occurrence of re-hospitalization (unscheduled hospitalization) within 30 and 90 days of randomization, EFFICACY: Duration in days of first hospitalization (excluding follow-up care, rehabilitation and long-term care units), EFFICACY: Proportion of newly institutionalized patients (i.e. entering a nursing home) at D90 and proportion of patients with a decrease ≥ 1 point on the activity of daily living (ADL) scale between their pre-randomization status and D90, EFFICACY: Time (in days) to death from any cause, end of study (D120) or date of last follow-up, whichever comes first, EFFICACY: Time (in days) to major CV event, death, end of study (D120) or date of last follow-up, whichever comes first, TOLERANCE: Frequency of major bleeding events (BARC classification >2) within 30 days, 90 days and 120 days of randomization, TOLERANCE: Frequency of bleeding events (any severity) within 30 days, 90 days and 120 days of randomization
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| All-cause mortality at D90 after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| EFFICACY: All-cause mortality at D30 and D120, EFFICACY: CV mortality at D30, D90 and D120 (i.e. mortality related to major CV events*), EFFICACY: Occurrence of major CV events (composite endpoint including at least one of the following: *myocardial infarction, stroke, heart failure, new atrial fibrillation, pulmonary embolism, CV death, sudden death) within 30 days, 90 days and 120 days of randomization, EFFICACY: Number of days in intensive care or resuscitation unit within 30 days and 90 days of randomization, EFFICACY: Occurrence of re-hospitalization (unscheduled hospitalization) within 30 and 90 days of randomization, EFFICACY: Duration in days of first hospitalization (excluding follow-up care, rehabilitation and long-term care units), EFFICACY: Proportion of newly institutionalized patients (i.e. entering a nursing home) at D90 and proportion of patients with a decrease ≥ 1 point on the activity of daily living (ADL) scale between their pre-randomization status and D90, EFFICAC | — |
Countries
France