ACETYLSALICYLIC ACID for Acute pneumonia

Inclusion criteria

• {"criterion_text":"- Informed consent obtained from the patient or a relative/trusted person if the patient is unable to consent\n- Age ≥75 years\n- Clinical diagnosis of AP, presumed to be of bacterial or viral origin, with at least two of the following signs or symptoms: - cough, - purulent expectoration, - thoracic pain, - dyspnea/tachypnea, - temperature > 37.8°C or < 36°C, - unilateral crackles\n- Patient hospitalized for at least 48 hours\n- Onset of clinical signs < 7 days\n- New radiological infiltrate documented by X-ray, ultrasound or CT scan"}

Exclusion criteria

• {"criterion_text":"- Mechanically ventilated pneumonia\n- Antiplatelet therapy\n- Steroidal or non-steroidal anti-inflammatory treatment or oral corticosteroids without a proton pump inhibitor (PPI)\n- Dyspepsia or gastroesophageal reflux disease (GERD) without PPIs\n- Treatment with methotrexate (>20 mg per week), anagrelide, probenecid, nicorandil, defibrotide\n- Contraindications to aspirin (preventive doses) or its placebo: •Hypersensitivity to acetylsalicylic acid or to any of the excipients of the investigational drug or placebo; •\tHistory of asthma induced by the administration of salicylates or non-steroidal anti-inflammatory drugs; •\tActive peptic ulcer disease or history of recurrent peptic ulcer disease; •History of cerebrovascular hemorrhage; •Previous gastrointestinal hemorrhage; •History of hemorrhage with Hemoglobin > 3g /dl requiring transfusion, vasoactive treatment or surgery; •Known hereditary or acquired coagulation disorder; •Thrombocytopenia (platelets < 50 giga/L); •Acute kidney injury (clairance < 15 ml/min selon MDRD - Modification of Diet in Renal Disease); •Liver cirrhosis or acute liver failure (PTT<50%); •Severe uncontrolled heart failure; •Persistent severe hypertension (systolic blood pressure > 180mmHg); •Patient with mastocytosis\n- Person not affiliated to a national health insurance\n- Patient under court protection\n- Documented SARS CoV2 pneumonia\n- Patient with at least 3 episodes of inhalation pneumonitis in the 12 months prior to inclusion\n- Pre-acute swallowing disorders impairing oral medication intake\n- Physician-assessed life expectancy < 90 days\n- Anticoagulant treatment (curative doses)"}

Primary endpoints

• {"endpoint_text":"- All-cause mortality at D90 after randomization","definition_or_measurement_approach":"All-cause mortality assessed at 90 days (D90) after randomization; endpoint is death from any cause by day 90 post-randomization."}

Secondary endpoints

• {"endpoint_text":"- EFFICACY: All-cause mortality at D30 and D120","definition_or_measurement_approach":"All-cause mortality assessed at day 30 and day 120 after randomization."}
• {"endpoint_text":"- EFFICACY: CV mortality at D30, D90 and D120 (i.e. mortality related to major CV events*)","definition_or_measurement_approach":"Cardiovascular-related mortality assessed at days 30, 90 and 120 post-randomization (deaths adjudicated as due to major CV events)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Composite incidence of specified major cardiovascular events within 30, 90 and 120 days of randomization."}
• {"endpoint_text":"- EFFICACY: Number of days in intensive care or resuscitation unit within 30 days and 90 days of randomization","definition_or_measurement_approach":"Count of days spent in ICU/resuscitation unit within 30 and 90 days after randomization."}
• {"endpoint_text":"- EFFICACY: Occurrence of re-hospitalization (unscheduled hospitalization) within 30 and 90 days of randomization","definition_or_measurement_approach":"Occurrence of unscheduled rehospitalizations within 30 and 90 days post-randomization (excluding follow-up/rehabilitation and long-term care units)."}
• {"endpoint_text":"- EFFICACY: Duration in days of first hospitalization (excluding follow-up care, rehabilitation and long-term care units)","definition_or_measurement_approach":"Length in days of first hospital stay following randomization, excluding specified unit types."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of patients newly entering long-term institutional care by day 90 and proportion with ≥1 point decline in ADL score from baseline to day 90."}
• {"endpoint_text":"- EFFICACY: Time (in days) to death from any cause, end of study (D120) or date of last follow-up, whichever comes first","definition_or_measurement_approach":"Time-to-event analysis: days from randomization to death, censored at day 120 or last follow-up."}
• {"endpoint_text":"- EFFICACY: Time (in days) to major CV event, death, end of study (D120) or date of last follow-up, whichever comes first","definition_or_measurement_approach":"Time-to-event analysis for first major CV event or death, censored at day 120 or last follow-up."}
• {"endpoint_text":"- TOLERANCE: Frequency of major bleeding events (BARC classification >2) within 30 days, 90 days and 120 days of randomization","definition_or_measurement_approach":"Incidence of major bleeding events defined as BARC >2 within 30, 90 and 120 days post-randomization."}
• {"endpoint_text":"- TOLERANCE: Frequency of bleeding events (any severity) within 30 days, 90 days and 120 days of randomization","definition_or_measurement_approach":"Incidence of any bleeding events (all severities) within 30, 90 and 120 days post-randomization."}

France

Earliest CTIS Part Ii Submission Date

05-11-2024

Latest Decision Or Authorization Date

10-09-2025

Processing Time Days

309

Number Of Sites

15

Number Of Participants

600

Primary sponsor

Full Name

Centre Hospitalier Universitaire De Dijon

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

France