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

对于近期患有急性冠状动脉综合征的患者，口服 RPR 109891 8 周

• 批准号: 6274532
• 负责人: FRANCESCA CATELLA-LAWSON
• 金额: $ 2.5万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-04-15 至 1998-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6274532
• 关键词: aspirin; chemoprevention; clinical research; clinical trials; coronary disorder; drug screening /evaluation; fibrinogen receptors; fibrinolytic therapy; human subject; human therapy evaluation; myocardial ischemia /hypoxia; pharmacokinetics; platelet aggregation inhibitors

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.

RPR 10981是一种口服活性血小板糖蛋白拮抗剂 (GP)IIb/IIIa复合物，也称为纤维蛋白原受体。 这 受体是激活的交联中的最终共同介质。 血小板形成聚集体。 GP IIb/IIIa拮抗剂抑制 无论用于诱导血小板聚集的激动剂如何， 聚合来 最近的大规模试验表明， GP IIb/IIIa拮抗剂的给药诱导显著的 冠状动脉介入术后不良缺血性临床结局减少 血管成形术 本研究将评估安全性和 RPR 109891 + 3剂（75、100、125 mg）的药效学反应 阿司匹林与安慰剂加阿司匹林相比，在近期（<14 急性冠状动脉综合征。 RPR 109891将被投标 60天 血小板聚集、出血时间和血浆RPR水平 将在第1、5和30天评估109891及其活性代谢产物。 将在25家临床试验机构共入组320例患者。