EUCTR2006-001704-37-SK进行中（未招募）1 期
A 36 week, multicenter, randomized, double-blind, placebo- controlled, parallel-group, pilot study to evaluate the efficacy and safety of aliskiren on the prevention of left ventricular remodeling in high risk post-AMI patients when added to optimized standard therapy
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 800
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. Male or female patients 18 years and older.
- •2. Patients within 7-42 days of an acute myocardial infarction associated with left
- •ventricular systolic dysfunction prior to Visit 1 (see below). A qualifying myocardial
- •infarction will require each of the following:
- •Typical clinical presentation consistent with myocardial infarction (i.e., chest pain,
- •shortness of breath)
- •Elevation of cardiac markers (any of the following will fulfill the requirement for
- •an increase in cardiac markers):
- •Both total CK and CK-MB are above the upper limit of normal (ULN) and either
- •total CK or CK-MB are at least twice the upper limit of normal (2xULN)
- •CK-MB is elevated to at least twice the upper limit of normal (2xULN) when
- •total CK is not available, and is confirmed by an accompanying Troponin T or I
- •level at least three times the upper limit of normal (3xULN)
- •Total CK is elevated to at least twice the upper limit of normal (2xULN) when
- •CK-MB is not available, or to above the ULN if confirmed by an accompanying
- •Troponin T or I level at least three times the upper limit of normal (3xULN)
- •Troponin T or I level is at least five times the upper limit of normal (5xULN).
- •Typical ECG changes, including evolving ST-segment or T-wave changes in two
- •or more contiguous ECG leads, the development of new pathological Q/QS
- •waves in two or more contiguous ECG leads, or the development of new left
- •bundle branch block.
- •3. Documented left ventricular systolic dysfunction associated with the qualifying
- •acute myocardial infarction obtained as a clinical evaluation (study) post-MI but
- •prior to Visit 1.
- •Systolic dysfunction will be defined by at least one of the following criteria:
- •Echocardiography: LVEF • Radionuclide ventriculography: LVEF • Ventricular contrast angiography: LVEF • Left Ventricular Wall Motion Index (LVWMI) >/= 1.5
- •4. Patients should be on stable doses of the following standard of care post-MI concomitant medications for at least 2 weeks prior to Visit 1 unless contraindicated due to intolerance:
- •A Beta-blocker
- •An Anti-platelet agent
- •Patients must be on stable evidence-based dose of an Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin Receptor Blocker (ARB) but not both, for at least 2 weeks prior to Visit 1, unless contarindicated due to intolerance. For patients not on an evidence/based dose of an ACEI or an ARB, the reason (e.g. patient intolerant of these medications) must be documented.
- •5. Patients who are eligible, able to participate in the study, and who consent to do
- •so after the purpose and nature of the investigation has been clearly explained to
- •them (written informed consent).
- •6. Qualifying Echocardiogram:
- •Patients who fulfill the screening inclusion and exclusion criteria will have a
- •qualifying echocardiogram performed and transmitted to the Echo Core
- •Laboratory. To be eligible for randomization, patients must fulfill the following
- •criteria by the core laboratory:
- •Acceptable image quality
- •Confirmed LVEF = 45%
- •Qualifying Myocardial Infarct Percentage = 20% (akinetic or dyskinetic segment
- •length as percent of total cavity perimeter).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
排除标准
- •For full list, please see protocol.
- •1. Patients requiring both ACEI and ARB combination therapy at V1 or any time
- •during the study.
- •2. Hypertrophic cardiomyopathies due to etiologies other than hypertension (i.e.,
- •idiopathic or valvular).
- •3. Severe refractory hypertension defined as MSSBP = 180 mmHg and/or MSDBP =
- •110 mmHg) at Visit 2.
- •4. Hemodynamically significant stenotic or obstructive valvular, subvalvular or
- •supravalvular lesions.
- •5. Secondary forms of cardiomyopathy such as restrictive cardiomyopathy or
- •infective cardiomyopathy (e.g., Chagas’ disease).
- •6. Cardiogenic shock or systolic BP < 100 mmHg or diastolic BP < 60 mmHg within
- •the 24 hours prior to Visit 1 or 2.
- •7. Estimated Glomerular Filtration Rate (eGFR) < 30 ml/min/1.73m2 using the MDRD
- •formula at Visit 1.
- •8. Stroke or transient ischemic event (TIA) within 6 months of Study Visit 1.
- •9. Serum potassium = 5.1 mEq/L, or dehydration at Study Visit 1.
- •10. Significant valvular cardiovascular disease expected to lead to cardiac surgery
- •during the course of the study.
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