A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism
NCT ID: NCT03108833
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
108 participants
INTERVENTIONAL
2017-06-06
2019-12-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low Dose Experimental Group
Recombinant Human Prourokinase:40mg
Recombinant Human Prourokinase
The drug is used for intravenous thrombolysis therapy
High Dose Experimental Group
Recombinant Human Prourokinase:50mg
Recombinant Human Prourokinase
The drug is used for intravenous thrombolysis therapy
Active Comparator Controlled Group
Alteplase:100mg if weight\>=65kg, 1.5mg/kg if weight\<65kg
Alteplase
The drug is used for intravenous thrombolysis therapy
Interventions
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Recombinant Human Prourokinase
The drug is used for intravenous thrombolysis therapy
Alteplase
The drug is used for intravenous thrombolysis therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
75 Years
ALL
No
Sponsors
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Tasly Biopharmaceuticals Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Fuwai Hospital
Beijing, Beijing Municipality, China
Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Wuhan Asia Heart Hospital
Wuhan, Hubei, China
Xiangya Hospital, Central South University
Changsha, Hunan, China
Jiangsu Province Hospital
Nanjing, Jiangsu, China
Nanjing First Hospital
Nanjing, Jiangsu, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, China
The First Hospital of Jilin University
Changchun, Jilin, China
The First Hospital of China Medical University
Shenyang, Liaoning, China
General Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi, China
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Other Identifiers
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TASLY-B1448
Identifier Type: -
Identifier Source: org_study_id
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