The REVEAL study

REVEAL 研究

• 批准号: 7963897
• 负责人: Dan Longo
• 金额: $ 2.58万
• 依托单位: NATIONAL INSTITUTE ON AGING
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/7963897
• 关键词: Acute; Animal Model; Cardiac; Cardiovascular system; Clinical Research; Clinical Trials Data Monitoring Committees; Contracts; Controlled Clinical Trials; Dose; Double-Blind Method; Enrollment; Epoetin Alfa; Erythropoietin; Hospitals; Infarction; Infusion procedures; Left Ventricular Remodeling; Magnetic Resonance Imaging; Myocardial Infarction; Neuraxis; Patients; Pharmaceutical Preparations; Phase; Placebo Control; Placebos; Randomized; Reperfusion Injury; Reporting; Research Institute; Safety; Serious Adverse Event; Stem cells; Tissues; heart dimension/size; preclinical study; prospective; protective effect; research study

This is a phase II multi-center, randomized, double-blind, placebo controlled clinical trial that is evaluating the safety and efficacy of a single dose of parenteral Erythropoietin in patients with acute ST-elevation myocardial infarctions. NIA is the sponsor of this research study, however no subject will be enrolled at the NIA. The study is coordinated by Duke Clinical Research Institute (DCRI) through a Contract with NIA. The study medication is being purchased by the NIA from OrthoBiotech LLC. The study is still ongoing. There have been several serious adverse events that have been reported. These as well as other safety information are periodically reviewed by the Data and Safety Monitoring Board

这是一项多中心、随机、双盲、安慰剂对照的 II 期临床试验，旨在评估单剂量肠外促红细胞生成素治疗急性 ST 段抬高型心肌梗死患者的安全性和有效性。 NIA 是这项研究的赞助商，但 NIA 不会招募受试者。 该研究由杜克临床研究所 (DCRI) 通过与 NIA 签订的合同进行协调。 研究药物由 NIA 从 OrthoBiotech LLC 购买。 该研究仍在进行中。已经报告了几起严重的不良事件。这些以及其他安全信息由数据和安全监测委员会定期审查