A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism
ERUPTE
A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism
1 other identifier
interventional
108
1 country
18
Brief Summary
This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2017
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 5, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedStudy Start
First participant enrolled
June 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 19, 2019
CompletedMarch 18, 2021
March 1, 2021
2.5 years
April 5, 2017
March 16, 2021
Conditions
Outcome Measures
Primary Outcomes (13)
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
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
Study Arms (3)
Low Dose Experimental Group
EXPERIMENTALRecombinant Human Prourokinase:40mg
High Dose Experimental Group
EXPERIMENTALRecombinant Human Prourokinase:50mg
Active Comparator Controlled Group
ACTIVE COMPARATORAlteplase:100mg if weight\>=65kg, 1.5mg/kg if weight\<65kg
Interventions
The drug is used for intravenous thrombolysis therapy
The drug is used for intravenous thrombolysis therapy
Eligibility Criteria
You may qualify if:
- Aged 18-75 years（Include the critical value）AND
- High-risk PE or medium high-risk PE AND
- PE symptom duration ≤14 days AND
- PLT≥100×10\^9/L，ALT and AST≤2.5ULN，TBIL\<ULN，Cr within the normal range AND
- Informed consent can be obtained from subject or Legally Authorized Representative
You may not qualify if:
- Hemorrhagic or unexplained stroke history
- Ischemic stroke or transient ischemic attack (TIA) within 6 months
- The existence of the central nervous system injury or tumor
- Severe trauma，major surgery or head injury within 3 weeks
- Active bleeding within 1 month
- Clinician deems high-risk for bleeding
- Using anticoagulants (after a washout period can be randomized)
- Pregnancy or delivery within 1 week
- Vascular puncture which can not be oppressed
- Cardiopulmonary resuscitation within 10 days
- Systolic blood pressure above 180 mmHg or diastolic blood pressure above 100mmHg
- Severe liver dysfunction
- Infective endocarditis
- Arterial aneurysm or arteriovenous malformation or suspected aortic dissection
- left atrial thrombus
- +9 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Fuwai Hospital
Beijing, Beijing Municipality, 100037, 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
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 5, 2017
First Posted
April 11, 2017
Study Start
June 6, 2017
Primary Completion
December 19, 2019
Study Completion
December 19, 2019
Last Updated
March 18, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will not share