A Phase III Study to Research the Efficacy and Safety on Prouk for ST Elevated Mycadial Infarction Patients in China
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 450
- 试验地点
- 1
- 主要终点
- To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms
研究概览
简要总结
The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.
详细描述
The purpose of the study is to evaluate the efficacy and safety of rh-prouk as pharmacoinvasive therapy on those ST Elevated Myocardial Infarctions patients, it is designed as a multicenter, active controlled, single blinded study. The primary endpoint is to assess percentage of patients achieve the coronary recanalization 90 minutes after thrombolysis. The secondary endpoint is to evaluate the mortality rate at day 30.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chest pain > 30 minutes, while <12 hours
- •Expected PCI related delayed time > 60 minutes, OR Door To Balloon time >90 minutes
- •ECG confirmed STEMI.
- •Age: 18--75 years old
- •Weight <=85Kg
- •Consent to participate in this study
- •Exclusion Criteria
- •Evidence of cardiac rupture;
- •ECG: new left bundle branch block;
- •Thrombolysis contradictions
- •Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery) or recent trauma to the head or cranium (i.e. < 3 months);
- •Active bleeding or known bleeding disorder.
- •Recent administration of any i.v. or s.c. anticoagulation within 12 hours includingunfractionated heparin, enoxaparin and/or bivalirudin or current use of oral anticoagulation(warfarin or coumadin);
- •Uncontrolled hypertension, defined as a single blood pressure measurement ≥ 180/110 mm Hg (systolic BP ≥ 180 mm Hg and/or diastolic BP ≥ 110 mm Hg) prior to randomisation;
- •Major surgery, biopsy of a parenchymal organ, or significant trauma within the past 2 months (this includes any trauma associated with the current myocardial infarction); Prolonged or traumatic cardiopulmonary resuscitation (> 10 minutes) within the past 2 Weeks Major surgery pending in the following 30 days;
排除标准
- 未提供
研究组 & 干预措施
rhprouk
rhprouk to be administrated in 60 minutes.
干预措施: rhprouk (Drug)
结局指标
主要结局
To compare the percentage of STEMI patients achieving the recanalization of Coronary between the two arms
时间窗: 90 minutes after administrative of active/comparator
次要结局
未报告次要终点