Effects of Recombinant Human Erythropoietin on Platelet Function in Patients With Acute Myocardial Infarction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Bleeding Time
研究概览
简要总结
The purpose of this study is to see if a naturally-occurring hormone called erythropoietin changes the action of platelets in the blood. Patients with heart attacks are treated with medicines to reduce the clotting action of platelets. This study is trying to determine whether erythropoietin alters the clotting action of platelets in patients receiving anti-platelet medicines. It is important to understand the effects of erythropoietin on platelets since preliminary studies in animals suggest that erythropoietin may protect the heart from damage during a heart attack.
详细描述
Anti-apoptotic effects of erythropoietin in experimental myocardial infarction (MI) and ischemia-reperfusion injury suggest potential for therapeutic benefit in patients with acute MI. Before the therapeutic potential of recombinant human erythropoietin (rHuEpo) in acute MI can be tested in large clinical trials, more information on the effects of short-term rHuEpo on platelet function are needed. Accordingly, the current proposal aims to determine the effects of rHuEpo (at a dose previously shown not to inhibit the anti-platelet effects of aspirin and clopidogrel in healthy subjects) on platelet function and other safety measures and measure of infarct size in patients with acute coronary syndromes receiving clinically-indicated standard anti-platelet therapy with aspirin, clopidogrel and glycoprotein Iib-IIIa inhibitors.
Specific Aim 1: To determine the effects of intravenous rHuEpo 400 U/kg daily for 3 days vs. placebo on in vivo and in vitro platelet function in patients with acute MI undergoing percutaneous revascularization.
Specific Aim 2: To obtain pilot data to estimate the effects of administration of rHuEpo 400 U/kg daily for 3 days vs. placebo on biochemical markers of myocardial infarction size and left ventricular ejection fraction in patients with acute MI undergoing percutaneous revascularization
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 21-75 years
- •Clinical evidence of acute myocardial infarction (MI) with total or sub-total occlusion on angiogram
- •Status post percutaneous revascularization procedure for acute MI with TIMI 3 flow
- •Ongoing clinically-indicated treatment with aspirin, thienopyridines
排除标准
- •Hemodynamic instability/shock or severe congestive heart failure
- •Time from onset of chest pain to revascularization procedure > 16 hours
- •Use of intravenous thrombolytic agents for treatment of MI
- •Known need for additional revascularization procedures
研究组 & 干预措施
A
recombinant human erythropoietin 200 U/kg IV daily for 3 days
干预措施: Recombinant human erythropoietin alfa (drug) (Drug)
B
Normal saline volume to match active treatment IV daily for 3 days
干预措施: Placebo (Drug)
结局指标
主要结局
Bleeding Time
时间窗: Change from Day 3 to Day 10
An integrated measure of in vivo platelet function and tissue hemostasis.
Platelet Function Assay Closure Time
时间窗: Change from Day 3 to Day 10
次要结局
- Circulating Endothelial Progenitor Cells(Day 3 and Day 10)
- Left Ventricular Ejection Fraction(Day 1 and Day 10)
- Serum Markers of Myocyte Damage(Baseline)
- Serum Markers of Apoptosis(Day 1 and Day 10)