Phase 2, Multicenter, Randomized, Parallel, 3-arm, Placebo-controlled Study to Assess Efficacy and Safety of CDR132L in Patients With Reduced Left Ventricular Ejection Fraction (≤ 45%) After Myocardial Infarction
概览
- 阶段
- 2 期
- 干预措施
- Placebo to CDR132L
- 疾病 / 适应症
- Myocardial Infarction, Acute
- 发起方
- Cardior Pharmaceuticals GmbH
- 入组人数
- 294
- 试验地点
- 92
- 主要终点
- Echocardiography (ECHO)
- 状态
- 已完成
- 最后更新
- 11天前
概览
简要总结
This is a Phase 2, multicenter, randomized, parallel, 3-arm, placebo-controlled study to assess efficacy and safety of CDR132L in patients with reduced Left Ventricular Ejection Fraction (LVEF) (≤ 45%) after myocardial infarction (MI). This study consists of a screening period (to occur at least 3 days after MI diagnosis), a 6-month double-blind period, and a 6-month extension period with the End of Study (EOS) Visit at Day 360/Month 12.
Two dosages of CDR132L will be tested against placebo on their effects on patients, who just had a heart attack in addition to standard care. The aim of the study is to show that CDR132L is safe and effective to improve heart failure in such patients.
研究者
入排标准
入选标准
- •Main Inclusion Criteria:
- •Male or female patients, aged ≥ 30 to ≤ 80 years at the date of signing informed consent which is defined as the beginning of the Screening Period.
- •Spontaneous acute mycardial infarction (AMI) (type I) based on the universal MI definition with randomization to occur no later than 14 days after index event diagnosis.
- •Patient with a LVEF ≤ 45% as measured by ECHO after MI diagnosis (STEMI or NSTEMI).
- •Patient with previous MI events in history can be included.
- •Patient with body weight of ≤ 120 kg.
- •N-terminal pro B-type natriuretic peptide level ≥ 125 pg/ml and \< 8000 pg/ml at screening.
- •Patient with STEMI/NSTEMI who underwent percutaneous coronary intervention for this event.
排除标准
- •A woman of childbearing potential (WOCBP).
- •Patient with HF of non-ischemic origin; e.g., myocarditis, alcoholic cardiomyopathy.
- •Patient with New York Heart Association (NYHA) class IV at screening or randomization.
- •Patient has any planned cardiac intervention (angiogram without angioplasty is acceptable) or any other planned surgery after the Screening Period.
- •Patient has severe valvular heart disease.
- •Patient has systolic BP \< 90 mmHg or \> 180 mmHg, diastolic BP \< 50 mmHg or \> 110 mmHg, and/or heart rate \< 50 or \> 100 beats/minute at screening or randomization.
- •Patient with an estimated glomerular filtration rate \< 30 mL/min/1.73 m2 or on dialysis.
- •Patient with hepatic insufficiency classified as Child-Pugh B or C.
- •Patient has medical history of disease(s) affecting the blood-brain-barrier, e.g., stroke within 6 months or multiple sclerosis.
- •Patient has medical history of bleeding disorders or has thrombocytopenia (platelets \< 100,000/μL).
研究组 & 干预措施
Placebo
Placebo intravenous in single dose on Day 1, Day 29 and Day 57
干预措施: Placebo to CDR132L
CDR132L 10 mg
CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57
干预措施: CDR132L
CDR132L 5 mg
CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57
干预措施: CDR132L
结局指标
主要结局
Echocardiography (ECHO)
时间窗: 6 months
Percent change from baseline (screening to occur at least 3 days after MI diagnosis as measured by ECHO \[central laboratory\]) in Left Ventricular End-Systolic Volume (LVESVI) at Month 6.