EUCTR2006-003819-45-DE进行中（未招募）不适用
PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF ERYTHROPOIETIN IN PATIENTS WITH ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION UNDERGOING PERCUTANEOUS CORONARY INTERVENTION.REVIVAL-3 (Regeneration of Vital Myocardium in ST-Segment Elevation Myocardial Infarction by Erythropoietin) - REVIVAL-3
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München0 个研究点开始时间: 2006年10月26日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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. Patients with ST-segment elevation myocardial infarction < 24h from pain start
- •2. Successful PCI and left ventricular ejection fraction <50%.
- •3. Informed, written consent
- •4. In women with childbearing potential a pregnancy test is obligatory.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Age = 18 years and > 80 years.
- •2. Cardiogenic shock.
- •3. Pericarditis.
- •4. Malignancies/other comorbid conditions conditions with life expectancy < 1 year.
- •5. Previous myocardial infarction.
- •6. Planned staged PCI or prior PCI within 30 days from index procedure
- •7. Uncontrolled hypertension >160/100mmHg unresponsive to therapy
- •8. Epilepsy.
- •9. 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; and patient’s
- •refusal to blood transfusion.
- •10. Hematologic disorders such as essential thrombocytosis, megakaryoblastic
- •leukemia, polycythemia vera
- •11. 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.
- •12. 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; haemostatic clips
- •13. Glomerular filtration rate < 30 ml/min or serum creatinine >30 mg/l or
- •dependence on renal dialysis.
- •14. Chronic liver disease with GOT > 5-fold over the normal range.
- •15. Allergy to erythropoietin / true anaphylaxis after prior exposure to contrast media
- •16. Phenylketonuria
- •17. Previous enrollment in this trial.
- •18. 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.
- •19. Patient’s inability to fully cooperate with the study protocol.
- •20. Other contraindication according to the summary of product characteristics of
- •recombinant human erythropoietin beta (NeoRecormon®).
研究者
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