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

最初，这项II期研究调查了每日给药DMP 754（一种IIb/IIIa血小板抑制剂）与阿司匹林在抑制冠心病患者血小板聚集、出血和血小板减少发生率方面的影响，为期6个月。该研究在1998年3月进行了修订，纳入了DMP 754和阿司匹林的联合治疗组。初步数据显示出血风险增加，因此1998年7月对方案进行了修订，删除了2.0mg DMP 754 +阿司匹林组及其比较组（单独2.0mg DMP 754）。我们在1998年5月至10月间招募了8名患者。在这8例患者中，有2例停药，1例是因为血小板计数减少，另1例是因为血液隐匿阳性。杜邦公司在达到招生目标后，于1998年12月关闭了招生。为期六个月的后续研究将于一九九九年五月结束。临床终点包括死亡、进展为心肌梗死、冠脉搭桥、复发性缺血PTCA、因缺血或不稳定型心绞痛住院。我们期望在1999年年底写出一份摘要供展示，梅奥的研究人员将是该摘要的共同作者，然后是一份手稿。

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.