Prevention of cardiovascular events in in patients with pneumonia

Conditions: Patients hospitalized with community-acquired pneumonia
Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

Registration Number: EUCTR2013-002799-42-IT

Lead Sponsor: Dipartimento di Medicina Interna e Specialità Mediche - Policlinico Umberto I - Sapienza Università di Roma

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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

• 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.<br>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 Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Intra-hospital myocardila injury assessed by high-sensitivity cardiac T Troponin within the first 72 hours from hospital admission.<br>2) Intra-hospital worsening of the ejection fraction assessed by 2D-echocardiogram.<br>3) Intra-hospital worsening of the endothelial function assessed by brachial artery ultrasound (flow-mediated dilatation)<br>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. <br>High-sensitivity Troponin T will be measured at baseline and after 12, 24, 36 and 72 hours from hospital admission.<br>The other biomarkers will be measured at hospital admission and hospital discharge.