EUCTR2010-024616-33-DK进行中（未招募）1 期
Phase II, multicenter, randomized, double-blind, placebo controlled study to assess safety and efficacy of TRO40303 for reduction of reperfusion injury in patients undergoing Percutaneous Coronary Intervention for acute myocardial infarction
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- TROPHOS SA
- 入组人数
- 180
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 and Female with non child-bearing potential (post menopausal, ovariectomised or hysterectomised) patients. Menopause is defined as age > 60 years, or between 45 and 60 years being amenorrheic for at least 2 years.
- •2.Age>18 years old
- •3.First acute myocardial infarction
- •4.Occlusion should affect the following coronaries: the Left Anterior Descending artery (LAD) or the dominant or balanced Right Coronary Artery (RCA) or the dominant or balanced left circumflex artery (LCx).
- •5.Acute myocardial infarction defined as
- •a)nitrate resistant chest pain = 30 min
- •b)ST-segment elevation = 2 mm in at least two contiguous chest leads. This inclusion criterion regarding ST elevation can be superseded by inclusion criterion 7.
- •6.Presenting within 6h of onset of chest pain
- •7.Clinical decision to treat with percutaneous coronary intervention
- •8.Occlusion of culprit artery with a Thrombolysis In Myocardial Infarction (TIMI) flow grade 0-1 at time of admission and before percutaneous coronary intervention.
- •9.Have signed an Informed Consent to participate to the trial before any study related procedure has been taken.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 108
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 72
排除标准
- •1.Cardiac arrest, ventricular fibrillation, cardiogenic shock, stent thrombosis, previous AMI, angina within 48h before infarction, previous CABG, treatment with intravenous fibrinolytic therapy within the 72 hours prior to PCI.
- •2.Atrial fibrillation (could confound CMR analysis)
- •3.Pace-maker
- •4.Concurrent inflammatory, infectious or malignant disease
- •5.Biliary obstruction or hepatic insufficiency
- •6.Be possibly dependant on the Investigator or the Sponsor (eg including but not limited to affiliated employee)
- •7.Participated in any other international drug or therapy study with a non-approved medication, within the previous 3 months.
- •8.Patient under guardianship
研究者
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