Aspirin to prevent cardiovascular events in patients with pneumonia

Phase 1

Recruiting

Conditions: Pneumonia, Myocardial infarction
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: CTIS2023-504553-12-01

Lead Sponsor: Amsterdam UMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 760

Inclusion Criteria

40 years or older, Community-acquired pneumonia, defined as clinical signs of pneumonia, and radiological evidence of a new infiltrate consistent with pneumonia, Moderate to severe CAP: CURB-65 score 2 or higher, or PSI score 3 or higher, Admitted to hospital

Exclusion Criteria

Conditions which require antiplatelet therapy, Use of vitamin K antagonists, direct oral anticoagulants or therapeutic LMWH, Contraindications for aspirin: recent (<1 month) hemorrhagic CVA, recent major gastro-intestinal bleeding or other hemorrhage, active bleeding, thrombocytopenia < 100, known hemorrhagic diathesis, allergy for salicylates., Uncontrolled hypertension (systolic BP>180 mm Hg or diastolic BP>110 mm Hg), Life expectancy less than one month, Pregnancy or breastfeeding

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether adding aspirin to antibiotic therapy in patients with moderate to severe community-acquired pneumonia will reduce the incidence of<br>acute coronary syndrome in hospitalized patients.;Secondary Objective: To investigate the effects of adding aspirin to antibiotic therapy, with regard to other cardiovascular events, length of hospital stay, mortality, adverse events, and cost-effectiveness., In the subgroup of patients who agree with additional blood-sampling and storage: To allow for future studies identifying the mechanisms of cardiovascular events in patients with pneumonia, and to investigate the effect of aspirin on these mechanisms.;Primary end point(s): Incidence of an acute coronary syndrome (ACS) up to day 180

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s):Length of hospital stay;Secondary end point(s):Mortality at day 90 and day 180;Secondary end point(s):Societal costs up to day 180 measured with IMCQ and IPCQ;Secondary end point(s):Health-related quality of life measured with the EQ-5D-5L;Secondary end point(s):Incidence of 4-point MACE (nonfatal stroke, nonfatal myocardial infarction, cardiovascular death and coronary revascularization) up to day 180;Secondary end point(s):Incidence of major bleeding complication and clinically relevant non-major bleeding up to day 90