THROMBOLYSIS IN MYOCARDIAL INFARCTION

心肌梗塞中的血栓溶解

• 批准号: 3661369
• 负责人: FREDERICK FEIT
• 金额: $ 16.87万
• 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/3661369
• 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).

心肌梗死溶栓治疗(TIMI)II期试验设计 以确定早期静脉溶栓治疗是否 急性心肌梗死的几个小时后应选择 经皮冠状动脉腔内成形术(PTCA)所有的病人都会 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出现后四小时内 脑梗塞。在一组TIMI临床中心，患者将被 随机单用rt-PA或rt-PA后行选择性血管成形术 这将在开始后三个小时执行 或在开始输注后18至36小时输注rt-PA Rt-PA。在所有其他TIMI临床中心，患者将被随机分配到 单用rt-PA或rt-PA加18~36小时PTCA。此外，在这些方面 后一种诊所，所有有资格启动的患者 β-受体阻滞剂治疗将被随机分为立即治疗或延期治疗 β-受体阻滞剂疗法。TIMI第二阶段的主要目标是 确定单独溶栓治疗与溶栓治疗的效果 治疗后18~36小时内行择期PTCA。校长 此比较的终点是总死亡率和总死亡率的组合终点 急性心肌梗死后三个月的非致命性心肌梗死 脑梗塞。次要目标包括对组合的评估 一年随访和脑梗塞后10天(住院)的终点 死亡率和脑梗塞)。