2024-510811-32-00招募中3 期
ASPAPY - Aspirin in acute pneumonia in the elderly: a multicenter, double-blind, randomized, placebo-controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 15
- 主要终点
- All-cause mortality at D90 after randomization
研究概览
简要总结
To evaluate the efficacy of aspirin on all-cause mortality after AP at 90 days (D90) after randomization.
入排标准
- 年龄范围
- 65 years 至 65+ years（65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Informed consent obtained from the patient or a relative/trusted person if the patient is unable to consent
- •Age ≥75 years
- •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
- •Patient hospitalized for at least 48 hours
- •Onset of clinical signs < 7 days
- •New radiological infiltrate documented by X-ray, ultrasound or CT scan
排除标准
- •Mechanically ventilated pneumonia
- •Antiplatelet therapy
- •Steroidal or non-steroidal anti-inflammatory treatment or oral corticosteroids without a proton pump inhibitor (PPI)
- •Dyspepsia or gastroesophageal reflux disease (GERD) without PPIs
- •Treatment with methotrexate (>20 mg per week), anagrelide, probenecid, nicorandil, defibrotide
- •Contraindications to aspirin (preventive doses) or its placebo: •Hypersensitivity to acetylsalicylic acid or to any of the excipients of the investigational drug or placebo; • History of asthma induced by the administration of salicylates or non-steroidal anti-inflammatory drugs; • Active 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
- •Person not affiliated to a national health insurance
- •Patient under court protection
- •Documented SARS CoV2 pneumonia
- •Patient with at least 3 episodes of inhalation pneumonitis in the 12 months prior to inclusion
- •Pre-acute swallowing disorders impairing oral medication intake
- •Physician-assessed life expectancy < 90 days
- •Anticoagulant treatment (curative doses)
结局指标
主要结局
All-cause mortality at D90 after randomization
All-cause mortality at D90 after randomization
次要结局
- 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
研究者
Chef de projets
Scientific
Centre Hospitalier Universitaire De Dijon
研究点 (15)
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