Study of Safety and Efficacy of Percutaneous Coronary Intervention Combined With Thrombolysis by Recombinant Human Prourokinase at Different Time
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The incidence of no reflow
研究概览
简要总结
Patients with acute ST-segment elevation myocardial infarction and thrombolysis indications, will be given the recombinant human prourokinase for thrombolysis treatment, and in accordance with the guidelines, will be treated with coronary angiography examination 3 to 24 hours after thrombolysis. The study will explore the best time for interventional therapy combined with thrombolysis.
详细描述
The noninferiority multicenter, prospective, randomized, controlled study of urokinase of restructuring the original design evaluation (rhPro - UK) at different times after thrombolysis combined with percutaneous coronary intervention（PCI）therapy of acute ST segment elevation myocardial infarction.Patients with acute ST segment elevation myocardial infarction and thrombolysis indications, will be given the recombinant human prourokinase for thrombolysis treatment, and in accordance with the guidelines, will be treated with coronary angiography examination 3 to 24 hours after thrombolysis. The study will explore the best time for interventional therapy combined with thrombolysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 19 to 70 years old, gender not limited
- •30 minutes or more persistent ischemia chest pain, and symptoms can't ease by treated by nitroglycerin
- •In two or more lead ecg ST-segment（the line between QRS complex finish point and the start point of T wave in electrocardiogram) elevation ≥ 0.1mv, or two or more than two neighboring chest lead ST-elevation ≥0.2mv
- •Persistent ischemia chest pain less than 6 hours, door to balloon time>90 minutes and transfer time >120 minutes
- •Accept coronary arteriography and intervention treatment
- •Signed informed consent
排除标准
- •Pregnancy and lactation, menstrual period women
- •Blood disease, clotting hemorrhagic disease, any part of active bleeding or bleeding tendency physique
- •History of trauma in two months, including biopsy and received surgical operation
- •History of the great vessels punctured in two weeks that could not oppression
- •History of ischemic or hemorrhagic stroke and cerebrovascular accident
- •Cardiac shock,reinfarction again, right ventricular myocardial infarction, history of cardiopulmonary resuscitation (CPR)
- •History of PCI or coronary artery bypass grafting（CABG）
- •Killip classification level III（a standard of heart function classification） or above, or cardiac mechanical complications such as cardiac rupture
- •History of eyeground hemorrhage
- •Currently use of therapeutic doses of anticoagulants, such as warfarin, etc
- •Uncontrolled hypertension, systolic blood pressure before thrombolysis is still 160 mmHg or higher, diastolic blood pressure is still 100 mmHg or higher
- •Active internal bleeding (such as gastrointestinal bleeding), urogenital system, or have not cure of peptic ulcer in four weeks
- •Severe liver and kidney dysfunction
- •Intracranial tumor, suspicious aortic dissection, arteriovenous malformation, aneurysm
- •Thrombolysis treatment in one week
- •Allergies of thrombolysis drug or contrast
- •Participated in any clinical trials within three months
结局指标
主要结局
The incidence of no reflow
时间窗: intraoperative
The investigators will check the incidence of no reflow after PCI（percutaneous coronary intervention） immediately.
Post-PCI（percutaneous coronary intervention） myocardial perfusion (TIMI flow grade)
时间窗: intraoperative
The investigators will check myocardial perfusion (TIMI flow grade) after PCI （percutaneous coronary intervention）immediately.
次要结局
- Post-PCI heart function(1 month, 3 month,6 month,12 month)
- Major Adverse Cardiovascular Events （MACE）(1 month, 3 month,6 month,12 month)
- The incidence of serious bleeding events(1 year)