ACETYLSALICYCLIC ACID CONTROLLED MULTI DOSE STUDY OF DMP 754 IN CORONARY ARTERY

DMP 754 在冠状动脉中的乙酰水杨酸控制多剂量研究

• 批准号: 6264956
• 负责人: STEPHEN L KOPECKY
• 金额: $ 2.01万
• 依托单位: MAYO CLINIC ROCHESTER
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6264956
• 关键词: aspirin; cardiovascular disorder chemotherapy; chemoprevention; clinical research; coronary disorder; human subject; human therapy evaluation; platelet aggregation; platelet aggregation inhibitors

Initially, this Phase II study investigated the effects of daily administration of DMP 754, a IIb/IIIa platelet inhibitor, versus aspirin on the inhibition of platelet aggregation, the incidenceof bleeding and thrombocytopenia in patients with coronary artery disease over a 6 month period of time. The study was amended in March 1998 to include combination therapy arms of DMP 754 and aspirin. Preliminary data suggested increased risk of bleeding so the protocol was amended in July 1998 to remove the 2.0 mg DMP 754 + Aspirin arm and its comparitor (2.0mg DMP 754 alone). We enrolled 8 patients between May and October 1998. Of those eight patients, two were discontinued, one due to decrease in platelet count and the other because of a positive hemoccult. DuPont closed enrollent December 1998 after meeting enrollment goals. The six-month study follow-up will conclude in May 1999. Clinical endpoints include death, progression to myocardial infarction, CABG, PTCA for recurrent ischemia, hospitalization for ischemia or unstable angina. We expect to generate an abstract for presentation, on which Mayo investigators will be co-authors, in late 1999 followed by a manuscript.

最初，这项II期研究调查了每日服用IIb/IIIa型血小板抑制剂- 该研究于1998年3月进行了修订，纳入了E754和阿司匹林的联合治疗组。初步数据表明出血风险增加，因此于1998年7月修订了方案，删除了2.0 mg阿司匹林+阿司匹林组及其对照组（2.0 mg阿司匹林+阿司匹林）。我们在1998年5月至10月期间招募了8名患者。 在这8例患者中，2例停药，1例由于血小板计数下降，另1例由于血潜血阳性。 杜邦在达到招生目标后，于1998年12月关闭了招生。 为期六个月的研究后续行动将于1999年5月结束。临床终点包括死亡、进展为心肌梗死、CABG、针对复发性缺血的PTCA、因缺血或不稳定型心绞痛住院。我们希望在1999年晚些时候产生一份摘要，然后是一份手稿，马约的研究人员将是共同作者。