Prospective, Randomized, Double-Blind, Placebo-Controlled Trial of Erythropoietin in Patients With ST-Segment-Elevation Myocardial Infarction Undergoing Percutaneous Coronary Intervention (REVIVAL-3)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction measured by magnetic resonance imaging
研究概览
简要总结
The purpose of this study is to determine whether erythropoietin is superior to placebo with respect to left ventricular ejection fraction in patients with ST-elevation myocardial infarction undergoing percutaneous coronary intervention.
详细描述
Erythropoietin has lately been shown to exert others than merely hematopoietic functions. Due to attenuation of cell apoptosis and necrosis and/or enhancing neovascularisation, erythropoietin could be protective after myocardial ischemia and reperfusion and lead to infarct size reduction and improvement in left ventricular function. In a controlled clinical trial, short-term administration of erythropoietin in patients with ischemic stroke was associated with a significantly better functional recovery, with a lower level of circulating damage markers and a strong trend to smaller infarct sizes measured by magnetic resonance imaging. While leaving hematocrit and platelet counts unchanged, short-term administration of erythropoietin was shown to be safe and very well tolerated (no side effects reported or observed). The protective effects of short-term erythropoietin in acute ischemic brain damage are further evaluated in an ongoing multi-center trial in Germany. Considering the preclinical and clinical data erythropoietin is an attractive candidate to be evaluated in patients with acute myocardial infarction. In a pilot trial enrolling 22 patients with acute myocardial infarction short-term administration of erythropoietin was shown to be safe and to significantly increase the level of endothelial progenitor cells after percutaneous coronary intervention. However, the very small population did not allow evaluating the benefit in left ventricular function or clinical outcomes.
The aim of the REVIVAL-3 study is to investigate whether there is additional benefit of short-term administration of erythropoietin in patients with acute myocardial infarction after successful primary percutaneous coronary intervention (PCI) in terms of left ventricular ejection fraction.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ST-Segment elevation myocardial infarction <24 h from pain onset
- •Successful primary PCI and left ventricular ejection fraction <50%
- •Informed, written consent
- •In women with childbearing potential a pregnancy test is mandatory
排除标准
- •Age < 18 and > 80 years
- •Cardiogenic shock
- •pericarditis
- •thrombolysis for the index infarction
- •malignancies/other comorbid conditions with life expectancy < 1 year
- •previous myocardial infarction
- •planned staged PCI or prior PCI within 30 days from index procedure
- •uncontrolled hypertension >160/100mmHg unresponsive to therapy
- •active bleeding; bleeding diathesis; history of gastrointestinal or genitourinary bleeding, recent trauma or major surgery < 1 month; history of intracranial bleeding or structural abnormalities; suspected aortic dissection; patient's refusal to blood transfusion
- •hematologic disorders such as essential thrombocytosis, megakaryoblastic leukemia, polycythemia vera
- •relevant hematologic deviations: hemoglobin < 100 g/l or hemoglobin > 160 g/l platelet count < 100 x 10^9 cells/l or platelet count > 600 x 10^9 cells/l
- •any contraindication to magnetic resonance imaging: electronically, magnetically and mechanically activated implants such as cardiac pacemakers, automatic cardioverter defibrillators, joint prostheses, surgical/vascular clips/ hearing aids, neurostimulators, infusion pumps etc metallic splinters in the eye ferromagnetic haemostatic clips in the central nervous system cochlear implants lead wires or similar wires prosthetic heart valves, if dehiscence is suspected non-ferromagnetic stapedial implants, hemostatic clips
- •glomerular filtration rate < 30 ml/min or serum creatinine > 30 mg/l or dependence on renal dialysis
- •chronic liver disease with GOT > 5-fold over the normal range
- •allergy to erythropoietin/true anaphylaxis after prior exposure to contrast media
- •phenylketonuria
- •previous enrollment in this trial
- •women who are known to be pregnant, who are of childbearing potential and test positive for pregnancy, who have given birth within the last 90 days, who are breastfeeding
- •patient's inability to fully cooperate with the study protocol
- •other contraindication according to the summary of product characteristics of recombinant human erythropoietin beta (NeoRecormon®)
研究组 & 干预措施
A
recombinant human erythropoietin beta
干预措施: Erythropoietin (Drug)
B
0.9% NaCl solution
干预措施: Placebo (Other)
结局指标
主要结局
Left ventricular ejection fraction measured by magnetic resonance imaging
时间窗: 4-6 months
次要结局
- Changes in left ventricular ejection fraction and infarct size(over 6 months)
- Death, recurrent myocardial infarction, IRA-revascularization and stroke(30 days, 6 months)