RPR 109891 ORALLY FOR 8 WEEKS IN PTS WITH RECENT ACUTE CORONARY ARTERY SYNDROMES

RPR 10981是血小板糖蛋白（GP） IIb/IIIa复合物（也称为纤维蛋白原受体）的口服活性拮抗剂。该受体是活化血小板交叉连接形成聚集体的最后共同介质。无论使用何种激动剂诱导血小板聚集，GP IIb/IIIa拮抗剂均可抑制血小板聚集。最近的大规模试验表明，GP IIb/IIIa拮抗剂可显著降低冠状动脉成形术后的不良缺血性临床结果。本研究将评估3剂量（75,100,125 mg） RPR 109891加阿司匹林与安慰剂加阿司匹林在近期（<14天）急性冠状动脉综合征患者中的安全性和药效学反应。RPR 109891的投标期限为60天。在第1、5和30天评估血小板聚集、出血时间和血浆RPR 109891及其活性代谢物水平。共有320名患者将被纳入25个中心。

RPR 10981 is an orally active antagonist of the platelet glycoprotein (GP) IIb/IIIa complex, also known as the fibrinogen receptor. This receptor is the final common mediator in the cross linkage of activated platelets to form an aggregate. GP IIb/IIIa antagonists inhibit platelet aggregation regardless of the agonist used to induce aggregation. Recent large scale trials have demonstrated that the administration of GP IIb/IIIa antagonists induces a significant reduction in adverse ischemic clinical outcomes following coronary angioplasty. The present study will evaluate the safety and pharmacodynamic response of 3 doses (75,100, 125 mg) of RPR 109891 plus aspirin compared to placebo plus aspirin in patients with recent (<14 days) acute coronary artery syndromes. RPR 109891 will be given bid for 60 days. Platelet aggregation, bleeding time and plasma levels RPR 109891 and its active metabolite will be assessed on day 1, 5 and 30. A total of 320 patients will be enrolled in 25 centers.