Patients hospitalized with community-acquired pneumonia
Conditions
Interventions
Trade Name: Cardioaspirin
Product Name: aspirin
Pharmaceutical Form:
INN or Proposed INN: aspirin
Other descriptive name: ACETYLSALICYLIC ACID
Trade Name: Torvast
Product Name: atorvastatin
Pharmace
Sponsors
Dipartimento di Medicina Interna e Specialità Mediche - Policlinico Umberto I - Sapienza Università di Roma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients hospitalized of community-acquired pneumonia Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: • Patients already treated with statins • Health Care—Associated Pneumonia • pneumonia due to immunodeficiency syndromes (congenital or acquired) • presence of neoplasms • chronic inflammatory diseases • patients considered at high risk of bleeding (liver disease, chronic renal failure with glomerular filtration rate <30 mg / dl) • age less than 18 years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Aim of the study is to optimize antithrombotic therapy in the acute phase of community-acquired pneumonia, a condition associated to high cardiovascular risk. We will evaluate the effectiveness of atorvastatin 40 mg plus aspirin 100 mg vs. aspirin 100 mg daily in preventing cardiovascular events and myocardial injury in patients hospitalized for community-acquired pneumonia.;Secondary Objective: Not applicable;Primary end point(s): Primary endopoint will be the first occurence of one of the following cardiovascular events: acute myocardial infarction, stroke, cardiovascular death, new or worsening heart failure, new or worsening arrhythmias.;Timepoint(s) of evaluation of this end point: 1, 6, 12, 18, 24 mesi. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) Intra-hospital myocardila injury assessed by high-sensitivity cardiac T Troponin within the first 72 hours from hospital admission. 2) Intra-hospital worsening of the ejection fraction assessed by 2D-echocardiogram. 3) Intra-hospital worsening of the endothelial function assessed by brachial artery ultrasound (flow-mediated dilatation) 4) Intra-hospital increase of biomarkers of platelet activation (urinary and serum thromboxane), inflammation (hs-CRP) and oxidative stress (sNOX2-dp, urinary and serum isoprostanes);Timepoint(s) of evaluation of this end point: Echocardiogram and brachial artery index (FMD assessed by ultrasound) will be assessed at hospital admission and hospital discharge. High-sensitivity Troponin T will be measured at baseline and after 12, 24, 36 and 72 hours from hospital admission. The other biomarkers will be measured at hospital admission and hospital discharge. | — |
Countries
Italy
Contacts
Public ContactI Clinica Medica
Dipartimento di Medicina Interna e Specialità Mediche - Policlinico Umberto I - Sapienza Università di Roma
Outcome results
None listed