NCT00648089已完成2 期
ErythroPOietin in Myocardial Infarction
University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication
研究概览
简要总结
EPOMI is a randomized, open-label, parallel phase II clinical study that will evaluate the effects of a single erythropoietin administration on infarct size and cardiac remodeling in patients with acute myocardial infarction. Eligible patients will be randomly assigned to receive conventional therapy and single infusion of 1000U/kg of epoetin beta or conventional therapy alone. Infarct size and cardiac remodeling parameters will be assessed by cardiac magnetic resonance imaging (MRI) within 3-7 days of the randomization and repeated 3 months later.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ST-Segment elevation myocardial infarction <6h
- •Infarct related artery : proximal circumflex artery , proximal and mid left anterior descending artery, 1st segment of the right coronary artery
- •TIMI 0 or 1 before angioplasty
- •Successful PCI defined by residual stenosis < 50% and TIMI 2 or 3 flow grade
- •Body weight : [50-110] kg
- •Informed, written consent
排除标准
- •Age < 18
- •Pregnant, or parturient or breast-feeding women;
- •Sexually active women without efficient contraception;
- •Inability to fully cooperate with the study protocol
- •Pre-treatment with fibrinolysis ;
- •Previous Q-wave myocardial infarction or previous aorto-coronary bypass;
- •History of deep vein thrombosis or pulmonary embolism;
- •Contraindication to aspirin or clopidogrel ;
- •Cardiogenic shock ;
- •Cardiac resuscitated before angioplasty ;
- •Past or active erythropoietin therapy;
- •Contraindications to erythropoietin therapy: uncontrolled hypertension, known hypersensitivity to benzoic acid, chronic liver insufficiency, hemoglobin> 16g / l, thrombocytosis, refractory anemia with excess of blasts;
- •Renal insufficiency (creatinine clearance <30ml/mn.);
- •Active Malignancies
- •Any contraindications to magnetic resonance imaging: pacemaker and automatic cardiac defibrillator, hearing aid, neurostimulator, infusion pump etc metallic splinters in the eye, ferromagnetic haemostatic clips in the central nervous system cochlear implants, claustrophobia;
- •Allergy to gadolinium ;
- •Patient refusal / patient not having provided written informed consent.
研究组 & 干预措施
1
Experimental
干预措施: EPO (Drug)
结局指标
主要结局
Changes in infarct size as assessed by magnetic resonance imaging 3 months after administration of study medication
时间窗: within 3-7 days of administration of study medication
次要结局
- End-systolic volume, end-diastolic volume, ejection fraction(within 3-7 days of administration of study medication, and 3 months later)
- Changes in hemoglobin, platelets, reticulocytes blood count(during the first 10 days following study medication administration)
- Occurrence of major cardiac event or venous thrombotic events(within 12 months following administration of study medication)
研究者
研究点 (2)
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