A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism

Phase 2

Completed

• Conditions: Acute Pulmonary Embolism
• Interventions: Drug: Recombinant Human Prourokinase; Drug: Alteplase

• Registration Number: NCT03108833
• Lead Sponsor: Tasly Biopharmaceuticals Co., Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-05
• Study First Submitted QC: 2017-04-10
• Study First Posted: 2017-04-11
• Study Start: 2017-06-06
• Primary Completion: 2019-12-19
• Study Completion: 2019-12-19
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-16
• Last Update Posted: 2021-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Dose Experimental Group	Recombinant Human Prourokinase	Recombinant Human Prourokinase:50mg
Low Dose Experimental Group	Recombinant Human Prourokinase	Recombinant Human Prourokinase:40mg
Active Comparator Controlled Group	Alteplase	Alteplase:100mg if weight\>=65kg, 1.5mg/kg if weight\<65kg

Primary Outcome Measures

Name	Time	Method
NT-proBNP	0，48hours and 30days after treatment	Changes of NT-proBNP from baseline 48hours and 30days after treatment
Incidence of death from all causes	From baseline to 30 days	Incidence of death from all causes
Incidence of recurrent pulmonary embolism	From baseline to 7 days	Incidence of recurrent pulmonary embolism
Qanadli CT Score	0 and 48hours after treatment	Change of Qanadli Score from baseline by CTPA 48hours 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
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
Major bleeding	From baseline to 30 days	The frequency of major bleeding
Incidence of hemodynamic deterioration	From baseline to 7 days	Incidence of hemodynamic deterioration
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(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
bleeding	From baseline to 30 days	The frequency of bleeding

Trial Locations

Locations (18)

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China

Fuwai Hospital; 🇨🇳 Beijing, Beijing, China

Anzhen Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Tongren Hospital,Capital Medical University; 🇨🇳 Beijing, Beijing, 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

General Hospital of Ningxia Medical University; 🇨🇳 Yinchuan, Ningxia, China

Jiangsu Province Hospital; 🇨🇳 Nanjing, Jiangsu, China

Xiangya Hospital, Central South University; 🇨🇳 Changsha, Hunan, China

The First Affiliated Hospital of Nanchang University; 🇨🇳 Nanchang, Jiangxi, China

The First Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Wuhan Asia Heart Hospital; 🇨🇳 Wuhan, Hubei, China

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, 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, China

Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China