Multicenter, randomized, double-blind, Phase III study of intravenous TAD® 600 mg/4 ml solution for injection to evaluate efficacy and safety in preventing myocardial injury in patients with pneumonia

Conditions

Myocardial injury in patients affected by pneumonia

Brief summary

Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups

Detailed description

Assessment at V0 versus of V2 of hs-cTn, Assessment at V0 versus V1 and V2 of the following parameters: • Creatine Phosphokinase-MB (CPK-MB)* • C-Reactive Protein (CRP). *CPK-MB will be evaluated only if enough patients have performed the assessment, Electrocardiographic assessment of heart rate and rhythm, atrio-ventricular and intraventricular conduction, ST segment/T-wave, atrial and/or ventricular hyper/hypokinetic arrhythmias, at V0 versus V1 and V2, Echocardiographic assessment of left ventricular Ejection Fraction (EF), left ventricular diastolic and systolic volume values, Pulmonary Artery Systolic Pressure (PASP) at V0 versus V1 and V2, Assessment of Brain Natriuretic Peptide (BNP) or N-Terminal pro B-type Natriuretic Peptide (NT-proBNP) at V0 versus V2, Qualitative and Quantitative Evaluation of all adverse drug reactions and adverse events and their frequency

Related papers

No related papers found yet.

Interventions

DRUGTAD 600 mg/4 ml polvere e solvente per soluzione iniettabile.

DRUGSodio cloruro B. Braun 0

DRUG9% soluzione per infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups	—

Secondary

Measure	Time frame
Assessment at V0 versus of V2 of hs-cTn, Assessment at V0 versus V1 and V2 of the following parameters: • Creatine Phosphokinase-MB (CPK-MB)* • C-Reactive Protein (CRP). *CPK-MB will be evaluated only if enough patients have performed the assessment, Electrocardiographic assessment of heart rate and rhythm, atrio-ventricular and intraventricular conduction, ST segment/T-wave, atrial and/or ventricular hyper/hypokinetic arrhythmias, at V0 versus V1 and V2, Echocardiographic assessment of left ventricular Ejection Fraction (EF), left ventricular diastolic and systolic volume values, Pulmonary Artery Systolic Pressure (PASP) at V0 versus V1 and V2, Assessment of Brain Natriuretic Peptide (BNP) or N-Terminal pro B-type Natriuretic Peptide (NT-proBNP) at V0 versus V2, Qualitative and Quantitative Evaluation of all adverse drug reactions and adverse events and their frequency	—

Measure

Time frame

Assessment at V0 versus of V2 of hs-cTn, Assessment at V0 versus V1 and V2 of the following parameters: • Creatine Phosphokinase-MB (CPK-MB)* • C-Reactive Protein (CRP). *CPK-MB will be evaluated only if enough patients have performed the assessment, Electrocardiographic assessment of heart rate and rhythm, atrio-ventricular and intraventricular conduction, ST segment/T-wave, atrial and/or ventricular hyper/hypokinetic arrhythmias, at V0 versus V1 and V2, Echocardiographic assessment of left ventricular Ejection Fraction (EF), left ventricular diastolic and systolic volume values, Pulmonary Artery Systolic Pressure (PASP) at V0 versus V1 and V2, Assessment of Brain Natriuretic Peptide (BNP) or N-Terminal pro B-type Natriuretic Peptide (NT-proBNP) at V0 versus V2, Qualitative and Quantitative Evaluation of all adverse drug reactions and adverse events and their frequency

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Countries

Italy

Outcome results

None listed