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This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Dose Experimental Group | Experimental | Recombinant Human Prourokinase:40mg |
|
| High Dose Experimental Group | Experimental | Recombinant Human Prourokinase:50mg |
|
| Active Comparator Controlled Group | Active Comparator | Alteplase:100mg if weight>=65kg, 1.5mg/kg if weight<65kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human Prourokinase | Drug | The drug is used for intravenous thrombolysis therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Qanadli CT Score | Change of Qanadli Score from baseline by CTPA 48hours after treatment | 0 and 48hours after treatment |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| NT-proBNP | Changes of NT-proBNP from baseline 48hours and 30days after treatment |
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Inclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fuwai Hospital | Beijing | Beijing Municipality | 100037 | China | ||
| Anzhen Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41916317 | Derived | Cheng CY, Fan FL, Wu BX, Hua L, Zhou HM, Ying KJ, Zheng ZQ, Zhang WH, Mi YH, Xie WP, Yu ZX, Liu R, Wang DL, Xu XQ, Jing ZC; ERUPTE Investigators. Evaluation of recombinant human prourokinase for acute pulmonary embolism: A phase 2, randomized clinical trial. Med. 2026 May 8;7(5):101068. doi: 10.1016/j.medj.2026.101068. Epub 2026 Mar 30. |
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| Alteplase | Drug | The drug is used for intravenous thrombolysis therapy |
|
|
| 0，48hours and 30days after treatment |
| Major bleeding | The frequency of major bleeding | From baseline to 30 days |
| bleeding | The frequency of bleeding | From baseline to 30 days |
| Incidence of death from all causes | Incidence of death from all causes | From baseline to 7 days |
| Incidence of recurrent pulmonary embolism | Incidence of recurrent pulmonary embolism | From baseline to 7 days |
| Incidence of death from all causes | Incidence of death from all causes | From baseline to 30 days |
| Incidence of hemodynamic deterioration | Incidence of hemodynamic deterioration | From baseline to 7 days |
| 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 |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001685 | Biological Factors |
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