EUCTR2016-002167-33-DE进行中（未招募）1 期
A randomized, double-blind multicenter study to assess the safety and efficacy of a six 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 (CHIARA MIA 2) - Chymase inhibitor BAY 1142524 in left-ventricular dysfunction after acute myocardial infarction
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- Bayer AG
- 入组人数
- 185
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Patients with first ST elevation myocardial infarction (STEMI) and treated with primary percutaneous coronary intervention (PCI) or thrombolysis within 24 h after symptom onset.
- •2. Diagnosis of STEMI requires the presence of the following 3 criteria: * Typical clinical symptoms such as chest pain, shortness of breath for more than 20 min 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 of creatinine kinase (CK) and creatinine kinase MB (6-10% of CK-MB).
- •3. 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).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 57
排除标准
- •1. Contraindication to perform MRI.
- •2. LVEF < 20%.
- •3. Previous MI, previous cardiac surgery such as CABG.
- •4. History of heart failure or LVEF < 50% before occurrence of the first STEMI.
- •5. Infarct size > 45% (g/g; LV mass) between 5 and 9 days after acute MI.
- •6. NYHA class IV at randomization.
- •7. Any planned cardiac intervention after baseline MRI or any other planned operations.
- •8. Non-ischemic causes for cardiomyopathy
- •9. Diagnosis of atrial Fibrillation
- •10. Systolic blood pressure < 100 mmHg or > 180 mmHg; diastolic blood pressure < 50 mmHg or > 110 mmHg; heart rate < 50 or > 100 beats / min
- •11. Most recent eGFR result since MI < 30 mL/min/1.73m2
- •12. Clinically relevant hepatic dysfunction
研究者
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