THROMBOLYSIS IN MYOCARDIAL INFARCTION

心肌梗塞中的血栓溶解

• 批准号: 3661372
• 负责人: FREDERICK FEIT
• 金额: $ 31.26万
• 依托单位: NEW YORK UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 1986
• 资助国家: 美国
• 起止时间: 1986-03-01 至 1988-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/3661372
• 关键词: beta adrenergic agent; cooperative study; drug administration routes; drug adverse effect; early diagnosis; fibrinolysis; fibrinolytic therapy; heart function; heart imaging /visualization /scanning; human morbidity; human mortality; human subject; human therapy evaluation; injection /infusion; intraluminal angioplasty; myocardial infarct sizing; myocardial infarction; plasminogen activator; radionuclide diagnosis

The Thrombolysis in Myocardial Infarction (TIMI) Phase II Trial is designed to determine whether intravenous thrombolytic therapy given in the early hours of an acute myocardial infarction should be followed by elective percutaneous transluminal coronary angioplasty (PTCA). All patients will be treated with recombinant tissue-type plasminogen activator (rt-PA) within four hours of the onset of symptoms of an acute myocardial infarction. In one group of TIMI Clinical Centers, patients will be randomized to rt-PA alone or to rt-PA followed by elective angioplasty which will be performed either at three hours after the start of the infusion of rt-PA or at 18 to 36 hours after the start of the infusion of rt-PA. In all other TIMI Clinical Centers, patients will be randomized to rt-PA alone or rt-PA plus 18 to 36 hours PTCA. In addition, in these latter clinics, all patients who are eligible for the initiation of beta-blocker therapy will be randomized to either immediate or deferred beta-blocker therapy. The primary objective of TIMI Phase II is to determine the effects of thrombolytic therapy alone versus thrombolytic therapy followed within 18 to 36 hours by elective PTCA. The principal endpoint for this comparison is the combined endpoint total mortality and nonfatal myocardial infarction at three months after an acute myocardial infarction. Secondary objectives include the assessment of the combination endpoint at one-year follow-up, and at 10 days post infarction (in-hospital mortality and infarction).

心肌梗死溶栓（TIMI）II期试验设计 以确定是否在早期给予静脉溶栓治疗， 小时的急性心肌梗死后，应选择 经皮腔内冠状动脉成形术（PTCA）。 所有患者将 接受重组组织型纤溶酶原激活剂（rt-PA）治疗 在急性心肌梗死症状发作后4小时内 梗塞 在一组TIMI临床中心，患者将 随机接受rt-PA单药治疗或rt-PA后行择期血管成形术 这将在开始后三小时进行， rt-PA输注或开始输注后18 - 36小时 rt-PA。 在所有其他TIMI临床中心，患者将被随机分配至 rt-PA单独或rt-PA +18至36小时PTCA。 此外，在这些 后诊所，所有有资格开始治疗的患者 β受体阻滞剂治疗将随机分为立即或延迟治疗 β受体阻滞剂治疗 TIMI II期的主要目的是 确定单独溶栓治疗与溶栓治疗的效果 治疗后18至36小时内进行择期PTCA。 校长 该比较的终点是总死亡率和 急性心肌梗死后3个月的非致命性心肌梗死 梗塞 次要目的包括评估联合用药 1年随访时和梗死后10天（住院期间）的终点 死亡率和梗塞）。