Documentation of Hemoglobin Kinetics in Response to Mircera® in Patients With Acute Myocardial Infarction (BEAT-STEMI Pilot)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months
研究概览
简要总结
Hypothesis:
Based on available pharmacokinetic data from healthy volunteers we hypothesize that the administration of a cumulative dose of 210μg of the continuous erythropoietin receptor activator, Mircera® (Roche), during 3 months post percutaneous coronary intervention (PCI) does not result in hemoglobin (Hb) levels >15 g/dl in patients with ST-segment elevation myocardial infarction (STEMI)
Design:
Prospective, open label single center pilot study
详细描述
This pilot trial will include 8 patients. The inclusion of 8 patients will allow to perform representative statistics of expected Hb kinetics in response to Mircera®.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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 (age 18 - 80 years) with acute STEMI undergoing PCI
排除标准
- •Hemoglobin levels >15g/dL
- •history of a myeloproliferative syndrome
- •thrombolysis for index infarction
- •anticipated additional revascularization within 3 months
- •cardiogenic shock
研究组 & 干预措施
Epopoetinum beta
Mircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI
干预措施: methoxy-polyethyleneglycol epoetin beta (Drug)
结局指标
主要结局
Proportion of patients exceeding Hemoglobin (Hb) of 15 g/L within 3 months
时间窗: three months
measurement of Hb at baseline and month 1, 2 and 3
次要结局
- Relative change in Hb from 1 to 2 months(second month)
- Maximal change in Hb within 3 months relative to baseline(three months)
- Relative change in Hb from baseline to 1 months(first month)
- Maximal change in Hematocrit (Hk) within 3 months relative to baseline(three months)
- change in platelet count within 3 months relative to baseline(three months)
- Safety endpoints including all cause mortality,myocardial infarction,stroke,hospitalization,life threatening arrhythmias,thromboembolic events,stent thrombosis,poorly controlled hypertension despite therapy,seizures(three months)
- Relative change in Hb from 2 to 3 months(third month)