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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03108833
Other study ID # TASLY-B1448
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date June 6, 2017
Est. completion date December 19, 2019

Study information

Verified date March 2021
Source Tasly Biopharmaceuticals Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 19, 2019
Est. primary completion date December 19, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Recombinant Human Prourokinase
The drug is used for intravenous thrombolysis therapy
Alteplase
The drug is used for intravenous thrombolysis therapy

Locations

Country Name City State
China Anzhen Hospital, Capital Medical University Beijing Beijing
China Beijing Tongren Hospital,Capital Medical University Beijing Beijing
China Fuwai Hospital Beijing Beijing
China The First Hospital of Jilin University Changchun Jilin
China Xiangya Hospital, Central South University Changsha Hunan
China West China Hospital of Sichuan University Chengdu Sichuan
China Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine Hangzhou Zhejiang
China The Second Affiliated Hospital of Harbin Medical University Harbin Heilongjiang
China The First Affiliated Hospital of Nanchang University Nanchang Jiangxi
China Jiangsu Province Hospital Nanjing Jiangsu
China Nanjing First Hospital Nanjing Jiangsu
China The First Hospital of China Medical University Shenyang Liaoning
China Tianjin Chest Hospital Tianjin Tianjin
China Wuhan Asia Heart Hospital Wuhan Hubei
China The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shanxi
China General Hospital of Ningxia Medical University Yinchuan Ningxia
China Henan Provincial People's Hospital Zhengzhou Henan
China The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan

Sponsors (1)

Lead Sponsor Collaborator
Tasly Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Qanadli CT Score Change of Qanadli Score from baseline by CTPA 48hours after treatment 0 and 48hours after treatment
Primary Average pulmonary artery pressure Changes of average pulmonary artery pressure from baseline 24hours,48hours,7days and 30days after treatment 0,24hours,48hours,7days and 30days after treatment
Primary Three tricuspid regurgitation velocity Changes of Three tricuspid regurgitation velocity from baseline 24hours,48hours,7days and 30days after treatment 0,24hours,48hours,7days and 30days after treatment
Primary RV to LV Diameter Ratio(Ultrasonic echocardiography) Changes of RV to LV Diameter Ratio from baseline 24hours,48hours,7days and 30days after treatment 0,24hours,48hours,7days and 30days after treatment
Primary RV to LV Diameter Ratio(CTPA) Changes of RV to LV Diameter Ratio from baseline 24hours,48hours,7days and 30days after treatment 0,24hours,48hours,7days and 30days after treatment
Primary Pulmonary systolic pressure Changes of pulmonary systolic pressure from baseline 24hours,48hours,7days and 30days after treatment 0,24hours,48hours,7days and 30days after treatment
Primary NT-proBNP Changes of NT-proBNP from baseline 48hours and 30days after treatment 0,48hours and 30days after treatment
Primary Major bleeding The frequency of major bleeding From baseline to 30 days
Primary bleeding The frequency of bleeding From baseline to 30 days
Primary Incidence of death from all causes Incidence of death from all causes From baseline to 7 days
Primary Incidence of recurrent pulmonary embolism Incidence of recurrent pulmonary embolism From baseline to 7 days
Primary Incidence of death from all causes Incidence of death from all causes From baseline to 30 days
Primary Incidence of hemodynamic deterioration Incidence of hemodynamic deterioration From baseline to 7 days
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