A Randomized, Double-blind, Multicenter Study to Assess the Safety and Efficacy of a 6 Month Oral Treatment With the Chymase Inhibitor BAY 1142524 at a Dose of 25 mg BID in Comparison to Placebo on Top of Standard of Care in Patients With Reduced Left-ventricular Ejection Fraction (LVEF≤ 45%) After Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 107
- 主要终点
- Change in left-ventricular ejection fraction (LVEF)
研究概览
简要总结
The purpose of the trial is the analysis of safety and efficacy of the chymase inhibitor BAY1142524 at a dose of 25 mg BID in comparison to placebo using a 6 months treatment period in patients with left-ventricular (LV) dysfunction after myocardial infarction (MI). BAY1142524 or placebo will be given on top of evidence-based standard of care for left-ventricular dysfunction after myocardial infarction. Primary objective is the analysis of first signs of efficacy as determined by favourable changes in functional parameters of adverse cardiac remodelling (i.e. endsystolic and enddiastolic volume index, ejection fraction). Secondary objective is the analysis of safety and tolerability as evidenced by the incidence and severity of adverse events. 30 patients have to complete treatment with verum and 30 patients have to complete treatment with placebo.
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)
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with first ST elevation myocardial infarction (STEMI) treated with primary percutaneous intervention (PCI) or thrombolysis within 24 hours after symptom onset
- •Diagnosis of STEMI requires the presence of the following three criteria:
- •Typical clinical symptoms such as chest pain, shortness of breath for more than 20 minutes related to the myocardial infarction
- •New ST elevation indicating myocardial infarction
- •Significant elevation in troponin T or I with at least one value above the 99th percentile upper reference limit (URL) and/or elevation creatine kinase (CK) and creatine kinase MB (6-10% of total CK)
- •At the screening period, on day 5 to 9 after MI, patients have to have a LVEF ≤ 45% and an infarct size >10% LV mass (as measured by LGE-MRI, central-blinded evaluation)
排除标准
- •Contraindication to perform contrast-enhanced cardiac MRI
- •LVEF < 20%
- •History of heart failure or LVEF < 50% before occurrence of the first STEMI
- •Infarct size > 45% (g/g; LV mass) between 5 and 9 days after myocardial infarction
- •NYHA (New York Heart Association) class IV at randomization
- •Any planned cardiac intervention after baseline MRI or any other planned operations
- •Non-ischemic causes for cardiomyopathy
- •Diagnosis of atrial fibrillation
- •Systolic blood pressure < 100 mm Hg or > 180 mm Hg; diastolic blood pressure < 50 mm Hg or >110 mm Hg, heart rate < 50 or >100 beat/minute; mean of triplicate values at randomization
- •Clinically relevant hepatic dysfunction
研究组 & 干预措施
Fulacimstat (BAY1142524)
30 patients with left-ventricular dysfunction after acute myocardial infarction
干预措施: Fulacimstat (BAY1142524) (Drug)
Placebo
30 patients with left-ventricular dysfunction after acute myocardial infarction
干预措施: Placebo (Drug)
结局指标
主要结局
Change in left-ventricular ejection fraction (LVEF)
时间窗: At 6 months
Change in end diastolic volume index (EDVI)
时间窗: At 6 months
Change in end systolic volume index (ESVI)
时间窗: At 6 months
次要结局
- Number of patients with adverse events(Up to 7 months)
- Number of patients with serious adverse events(Up to 7 months)