Clinical trial NCT03108833: A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism
Official title: A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Pulmonary Embolism
Lead sponsor: Tasly Biopharmaceuticals Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-04-11
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Qanadli CT Score
timeFrame: 0 and 48hours after treatment
measure: Average pulmonary artery pressure
timeFrame: 0,24hours，48hours，7days and 30days after treatment
measure: Three tricuspid regurgitation velocity
timeFrame: 0,24hours，48hours，7days and 30days after treatment
measure: RV to LV Diameter Ratio(Ultrasonic echocardiography)
timeFrame: 0,24hours，48hours，7days and 30days after treatment
measure: RV to LV Diameter Ratio(CTPA)
timeFrame: 0,24hours，48hours，7days and 30days after treatment
measure: Pulmonary systolic pressure
timeFrame: 0,24hours，48hours，7days and 30days after treatment
measure: NT-proBNP
timeFrame: 0，48hours and 30days after treatment
measure: Major bleeding
timeFrame: From baseline to 30 days
measure: bleeding
timeFrame: From baseline to 30 days
measure: Incidence of death from all causes
timeFrame: From baseline to 7 days
measure: Incidence of recurrent pulmonary embolism
timeFrame: From baseline to 7 days
measure: Incidence of death from all causes
timeFrame: From baseline to 30 days
measure: Incidence of hemodynamic deterioration
timeFrame: From baseline to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital
state: Beijing
city: Beijing
country: China
facility: Anzhen Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tongren Hospital,Capital Medical University
state: Beijing
city: Harbin
country: China
facility: The Second Affiliated Hospital of Harbin Medical University
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Zhengzhou University
state: Henan
city: Wuhan
country: China
facility: Wuhan Asia Heart Hospital
state: Hubei
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
state: Hunan
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
city: Nanchang
country: China
facility: The First Affiliated Hospital of Nanchang University
state: Jiangxi
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
state: Ningxia
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Chest Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: