2023-503950-11-00招募中3 期
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
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.7 个研究点 分布在 1 个国家目标入组 178 人开始时间: 2024年2月19日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 178
- 试验地点
- 7
- 主要终点
- Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups
研究概览
简要总结
TAD® used as an add-on treatment, due to the presence of the sodium salt glutathione, could be effective and safe in preventing myocardial injury in hospitalized patients with pneumonia.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with an age of ≥ 18 and ≤ 85 years
- •Diagnosis of CAP or HAP requiring hospitalization
- •Patients with one of the following (a or b*): a. At least one cardiovascular comorbidity: • Chronic atrial fibrillation • History of ischemic heart disease (≥ 3 months) • History of heart failure (NYHA class I e II) • Cardiac Valvular Disease • Previous (≥ 2 months) episode of myocarditis or pericarditis b. Very high risk of developing cardiovascular diseases according to the SCORE2 and SCORE2-OP risk models for moderate risk European regions (score ≥ 7.5% for patients 40-50 years old, score ≥ 10% for patients 50-69 years old, and score ≥ 15% for patients ≥ 70 years old). * Please note that if the patient meets inclusion criterion 3(a), the CVD risk should not be calculated.
- •Provision of written informed consent as approved by the Ethics Committee (EC) by the patient or his/her legal representative.
排除标准
- •Active malignancy with a life expectancy < 2 years
- •History of hypersensitivity to glutathione or any excipients
- •Use of drugs containing sacubitril
- •Use of drugs with antioxidant activity in the last 3 months
- •Routine use or abuse of narcotics
- •Use of invasive mechanical ventilation
- •Patients unable or unwilling to comply with the appointments after hospitalization or with all the requirements of the Protocol
- •Recent (< 1 month) myocardial revascularization
- •Women of child-bearing potential not using at least one effective contraceptive method for the entire trial
- •Pregnant or breastfeeding women
- •Women of child-bearing potential not using at least one effective contraceptive method for the entire trial
- •Participation in other investigational drug or device clinical trials within 30 days prior to study screening
- •History of severe heart failure (NYHA class III and IV)
- •Severe to end-stage renal failure (eGFR < 30 mL/min)
- •History of severe liver disease
结局指标
主要结局
Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups
Assessment of the change of levels of high-sensitivity cardiac Troponin (hs-cTn) at V1 versus V0 in the two groups
次要结局
- 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
研究者
President & CEO
Scientific
Biomedica Foscama Industria Chimico-Farmaceutica S.p.A.
研究点 (7)
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