NCT05350969已完成2 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 92
- 主要终点
- Echocardiography (ECHO)
研究概览
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Pharmacy staff is unblinded. They will hand-over prepared investigational medicinal product (IMP) in light-protected syringe.
入排标准
- 年龄范围
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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).
- •Patient has poorly controlled diabetes as determined by the Investigator.
- •Patient has a history or presence of any of the following cardiac conditions: known structural cardiac abnormalities beyond HF, family history of long QT syndrome, cardiac syncope, or recurrent, idiopathic syncope.
- •Any clinically significant abnormalities, at the discretion of the Investigator, in rhythm, conduction, or morphology of resting ECG that pose an additional safety risk to patients.
- •Patient with active "severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)" infection confirmed as per the local testing guidelines at screening.
- •Patient is not to be enrolled into the study if they received any prohibited therapy within 3 months of screening.
研究组 & 干预措施
CDR132L 10 mg
Experimental
CDR132L 10 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57
干预措施: CDR132L (Drug)
CDR132L 5 mg
Experimental
CDR132L 5 mg/kg body weight intravenous in single dose on Day 1, Day 29 and Day 57
干预措施: CDR132L (Drug)
Placebo
Placebo Comparator
Placebo intravenous in single dose on Day 1, Day 29 and Day 57
干预措施: Placebo to CDR132L (Drug)
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.
Percent Change From Baseline in LVESVI (Left Ventricular End-systolic Volume Index) at Month 6
时间窗: Baseline (Day 1), Month 6
Percent change from baseline in LVESVI at Month 6 is presented. LVESVI is considered one of the standard echocardiography (ECHO) markers for assessing risks in ischemic heart failure (HF). The ECHO was performed to assess LVESVI.
次要结局
- Number of Treatment Emergent Adverse Events (TEAEs)(Up to 12 months)
- Number of Treatment Emergent Serious Adverse Events (TESAEs)(Up to 12 months)
- Number of Participants With Abnormalities in Clinically Relevant Laboratory Assessments(At month 6)
- Number of Participants With Clinically Relevant Laboratory Abnormalities in Vital Signs Parameters(At month 12)
- Number of Participants With Clinically Relevant Laboratory Abnormalities in ECG Parameters(At month 12)
- Absolute Change From Baseline in Left Ventricular Ejection Fraction (LVEF) at Month 3(Baseline (Day 1), Month 3)
- Absolute Change From Baseline in LVESVI at Month 3(Baseline (Day 1), Month 3)
- Absolute Change From Baseline in LVEF at Month 6(Baseline (Day 1), Month 6)
- Absolute Change From Baseline in LVEF at Month 12(Baseline (Day 1), Month 12)
- Relative Change From Baseline in LVEF at Month 3(Baseline (Day 1), Month 3)
- Relative Change From Baseline in LVEF at Month 6(Baseline (Day 1), Month 6)
- Relative Change From Baseline in LVEF at Month 12(Baseline (Day 1), Month 12)
- Absolute Change From Baseline in LVESVI at Month 6(Baseline (Day 1), Month 6)
- Absolute Change From Baseline in LVESVI at Month 12(Baseline (Day 1), Month 12)
- Relative Change From Baseline in LVESVI at Month 3(Baseline (Day 1), Month 3)
- Relative Change From Baseline in LVESVI at Month 12(Baseline (Day 1), Month 12)
- Absolute Change From Baseline in Troponin T at Month 3(Baseline (Day 1), Month 3)
- Absolute Change From Baseline in Troponin T at Month 6(Baseline (Day 1), Month 6)
- Absolute Change From Baseline in Troponin T at Month 12(Baseline (Day 1), Month 12)
- Relative Change From Baseline in Troponin T at Month 3(Baseline (Day 1), Month 3)
- Relative Change From Baseline in Troponin T at Month 6(Baseline (Day 1), Month 6)
- Relative Change From Baseline in Troponin T at Month 12(Baseline (Day 1), Month 12)
- Absolute Change From Baseline in N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) at Month 1(Baseline (Day 1), Month 1)
- Absolute Change From Baseline in NT-proBNP at Month 2(Baseline (Day 1), Month 2)
- Absolute Change From Baseline in NT-proBNP at Month 3(Baseline (Day 1), Month 3)
- Absolute Change From Baseline in NT-proBNP at Month 6(Baseline (Day 1), Month 6)
- Absolute Change From Baseline in NT-proBNP at Month 12(Baseline (Day 1), Month 12)
- Relative Change From Baseline in NT-proBNP at Month 1(Baseline (Day 1), Month 1)
- Relative Change From Baseline in NT-proBNP at Month 2(Baseline (Day 1), Month 2)
- Relative Change From Baseline in NT-proBNP at Month 3(Baseline (Day 1), Month 3)
- Relative Change From Baseline in NT-proBNP at Month 6(Baseline (Day 1), Month 6)
- Relative Change From Baseline in NT-proBNP at Month 12(Baseline (Day 1), Month 12)
- Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 6(Baseline (Day 1), Month 6)
- Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 6(Baseline (Day 1), Month 6)
- Absolute Change From Baseline in Mean KCCQ Score (Overall Summary Score) at Month 12(Baseline (Day 1), Month 12)
- Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 6(Baseline (Day 1), Month 6)
- Absolute Change From Baseline in KCCQ Subdomain Score (Symptom Burden) at Month 12(Baseline (Day 1), Month 12)
- Absolute Change From Baseline in KCCQ Subdomain Score (Physical Limitation) at Month 12(Baseline (Day 1), Month 12)
- Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 6(Baseline (Day 1), Month 6)
- Absolute Change From Baseline in KCCQ Subdomain Score (Quality of Life) at Month 12(Baseline (Day 1), Month 12)
研究者
研究点 (92)
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