A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism

• Status: Completed
• Trial end date: 2019-12-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tasly Biopharmaceuticals Co., Ltd.; Tasly Pharmaceuticals, Inc.
• Treatments: Saruplase; Tissue Plasminogen Activator

Criteria

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，TBIL5. 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