A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism

A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism

This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.

Inclusion Criteria:

1. Aged 18-75 years（Include the critical value）AND
2. High-risk PE or medium high-risk PE AND
3. PE symptom duration ≤14 days AND
4. PLT≥100×10^9/L，ALT and AST≤2.5ULN，TBIL<ULN，Cr within the normal range AND
5. Informed consent can be obtained from subject or Legally Authorized Representative

Exclusion Criteria:

1. Hemorrhagic or unexplained stroke history
2. Ischemic stroke or transient ischemic attack (TIA) within 6 months
3. The existence of the central nervous system injury or tumor
4. Severe trauma，major surgery or head injury within 3 weeks
5. Active bleeding within 1 month
6. Clinician deems high-risk for bleeding
7. Using anticoagulants (after a washout period can be randomized)
8. Pregnancy or delivery within 1 week
9. Vascular puncture which can not be oppressed
10. Cardiopulmonary resuscitation within 10 days
11. Systolic blood pressure above 180 mmHg or diastolic blood pressure above 100mmHg
12. Severe liver dysfunction
13. Infective endocarditis
14. Arterial aneurysm or arteriovenous malformation or suspected aortic dissection
15. left atrial thrombus
16. Neurosurgery or eye surgery within 1 month
17. Hemorrhagic diabetic retinopathy
18. Serious cardiac insufficiency
19. ventricular arrhythmias
20. Known allergic to prourokinase，urokinase，recombinant tissue-type plasminogen activator，contrast agent or any drug in the trial
21. Do not allow for 30 days' study
22. Any disease or condition is not suitable for intravenous thrombolysis
23. 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
24. Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions