A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 18
- 主要终点
- NT-proBNP
研究概览
简要总结
This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.
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
- •Aged 18-75 years（Include the critical value）AND
- •High-risk PE or medium high-risk PE AND
- •PE symptom duration ≤14 days AND
- •PLT≥100×10^9/L，ALT and AST≤2.5ULN，TBIL<ULN，Cr within the normal range AND
- •Informed consent can be obtained from subject or Legally Authorized Representative
排除标准
- •Hemorrhagic or unexplained stroke history
- •Ischemic stroke or transient ischemic attack (TIA) within 6 months
- •The existence of the central nervous system injury or tumor
- •Severe trauma，major surgery or head injury within 3 weeks
- •Active bleeding within 1 month
- •Clinician deems high-risk for bleeding
- •Using anticoagulants (after a washout period can be randomized)
- •Pregnancy or delivery within 1 week
- •Vascular puncture which can not be oppressed
- •Cardiopulmonary resuscitation within 10 days
- •Systolic blood pressure above 180 mmHg or diastolic blood pressure above 100mmHg
- •Severe liver dysfunction
- •Infective endocarditis
- •Arterial aneurysm or arteriovenous malformation or suspected aortic dissection
- •left atrial thrombus
- •Neurosurgery or eye surgery within 1 month
- •Hemorrhagic diabetic retinopathy
- •Serious cardiac insufficiency
- •ventricular arrhythmias
- •Known allergic to prourokinase，urokinase，recombinant tissue-type plasminogen activator，contrast agent or any drug in the trial
- •Do not allow for 30 days' study
- •Any disease or condition is not suitable for intravenous thrombolysis
- •Lactating women or plan to pregnant women during the trial，or don't want to during the study period using effective contraception or abstinence of male and female patients with possibility of fertility
- •Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions
研究组 & 干预措施
Low Dose Experimental Group
Recombinant Human Prourokinase:40mg
干预措施: Recombinant Human Prourokinase (Drug)
High Dose Experimental Group
Recombinant Human Prourokinase:50mg
干预措施: Recombinant Human Prourokinase (Drug)
Active Comparator Controlled Group
Alteplase:100mg if weight>=65kg, 1.5mg/kg if weight<65kg
干预措施: Alteplase (Drug)
结局指标
主要结局
NT-proBNP
时间窗: 0，48hours and 30days after treatment
Changes of NT-proBNP from baseline 48hours and 30days after treatment
Incidence of death from all causes
时间窗: From baseline to 30 days
Incidence of death from all causes
Incidence of recurrent pulmonary embolism
时间窗: From baseline to 7 days
Incidence of recurrent pulmonary embolism
Qanadli CT Score
时间窗: 0 and 48hours after treatment
Change of Qanadli Score from baseline by CTPA 48hours after treatment
Pulmonary systolic pressure
时间窗: 0,24hours，48hours，7days and 30days after treatment
Changes of pulmonary systolic pressure from baseline 24hours，48hours，7days and 30days after treatment
RV to LV Diameter Ratio(Ultrasonic echocardiography)
时间窗: 0,24hours，48hours，7days and 30days after treatment
Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment
Major bleeding
时间窗: From baseline to 30 days
The frequency of major bleeding
Average pulmonary artery pressure
时间窗: 0,24hours，48hours，7days and 30days after treatment
Changes of average pulmonary artery pressure from baseline 24hours，48hours，7days and 30days after treatment
Three tricuspid regurgitation velocity
时间窗: 0,24hours，48hours，7days and 30days after treatment
Changes of Three tricuspid regurgitation velocity from baseline 24hours，48hours，7days and 30days after treatment
Incidence of hemodynamic deterioration
时间窗: From baseline to 7 days
Incidence of hemodynamic deterioration
RV to LV Diameter Ratio(CTPA)
时间窗: 0,24hours，48hours，7days and 30days after treatment
Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment
bleeding
时间窗: From baseline to 30 days
The frequency of bleeding
次要结局
未报告次要终点