Acute Pulmonary Embolism
Conditions
Brief summary
This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.
Interventions
The drug is used for intravenous thrombolysis therapy
DRUGAlteplase
The drug is used for intravenous thrombolysis therapy
Sponsors
Tasly Biopharmaceuticals Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qanadli CT Score | 0 and 48hours after treatment | Change of Qanadli Score from baseline by CTPA 48hours after treatment |
| Average pulmonary artery pressure | 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 | 0,24hours，48hours，7days and 30days after treatment | Changes of Three tricuspid regurgitation velocity from baseline 24hours，48hours，7days and 30days after treatment |
| RV to LV Diameter Ratio(Ultrasonic echocardiography) | 0,24hours，48hours，7days and 30days after treatment | Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment |
| RV to LV Diameter Ratio(CTPA) | 0,24hours，48hours，7days and 30days after treatment | Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment |
| Pulmonary systolic pressure | 0,24hours，48hours，7days and 30days after treatment | Changes of pulmonary systolic pressure from baseline 24hours，48hours，7days and 30days after treatment |
| NT-proBNP | 0，48hours and 30days after treatment | Changes of NT-proBNP from baseline 48hours and 30days after treatment |
| Major bleeding | From baseline to 30 days | The frequency of major bleeding |
| bleeding | From baseline to 30 days | The frequency of bleeding |
| Incidence of death from all causes | From baseline to 7 days | Incidence of death from all causes |
| Incidence of recurrent pulmonary embolism | From baseline to 7 days | Incidence of recurrent pulmonary embolism |
| Incidence of hemodynamic deterioration | From baseline to 7 days | Incidence of hemodynamic deterioration |
Countries
China
Outcome results
None listed