Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD
Low Dose Rt-PA Plus LMWH Compared With LMWH Alone for the Treatment of Normotensive Pulmonary Embolism Patients With Acute RV Dysfunction: A Randomized，Multi-Center，Controlled Trial
1 other identifier
interventional
460
1 country
35
Brief Summary
In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events. The aim of the study is to compare thrombolytic treatment with LMWH in patients with acute normotensive PE with right ventricular dysfunction(RVD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2009
Longer than P75 for phase_4
35 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
Study Start
First participant enrolled
July 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 9, 2012
CompletedFirst Posted
Study publicly available on registry
February 13, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFebruary 14, 2012
February 1, 2012
3 years
February 9, 2012
February 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
the composite end point of death from any cause or treatment failure,recurrence of VTE
7 days
improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs
7 days
serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes
7 days
clinical relevant non-major bleedings
7 days
Secondary Outcomes (4)
the composite end point of death from any cause or treatment failure,recurrence of VTE
3 months and 6 months
improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs
3 months and 6 months
serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes
3 months and 6 months
clinical relevant non-major bleedings
3 months and 6 months
Study Arms (2)
Low dose (50mg/2h) rt-PA plus LMWH
EXPERIMENTALLow dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) plus low molecular weight heparin(LMWH)regimen
LMWH
ACTIVE COMPARATORLow molecular weight heparin
Interventions
Low dose (50mg/2h) rt-PA plus LMWH
Eligibility Criteria
You may qualify if:
- y≤Age≤75y
- Acute PE (first symptoms occurred 14 d or less before randomization) confirmed by lung scan, or a positive computed tomographic pulmonary angiogram, or a positive selective pulmonary angiogram
- Hemodynamic stability, diastolic pressure\>90mmHg.
- RV dysfunction confirmed by echocardiography (≥1 criterion), except left-side heart disease, congenital heart disease and mitral valve disease.
- Increase of the right ventricle showed presented with RV end-diastolic anteroposterior diameter \>25 mm, Right/left ventricular end-diastolic diameter \>1 (apical or subcostal 4-chamber view) or Right/left ventricular end-diastolic anteroposterior diameter \>0.5
- Hypokinesis of RV-free wall (range of motion less than 5 mm)
- Tricuspid regurgitation pressure \>30mmHg
You may not qualify if:
- RV anterior wall thickness \> 5mm confirmed by echocardiography
- Active internal bleeding and spontaneous intracranial hemorrhage in preceding 6 months
- Major surgery, organ biopsy or non-compressible punctures within 2 weeks
- Ischemic stroke occurred within 2 months
- Gastrointestinal bleeding within 10 days
- Severe trauma occurred within15 days
- Neurosurgery or eye surgery within 1 months
- Severe hypertension difficult to control (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg)
- Cardiopulmonary resuscitation
- Platelet count less than 100×109 / L
- Pregnancy, or within 2 week post partum
- Infective endocarditis; left atrial thrombus; aneurysm
- Serious liver and kidney dysfunction
- Diabetic hemorrhagic retinopathy
- Suffering with bleeding disorders
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Beijing Chao Yang Hospial
Beijing, Beijing Municipality, 100020, China
Beijing Daxing People's Hospital
Beijing, Beijing Municipality, China
Beijing Fuwai Hospital
Beijing, Beijing Municipality, China
Beijing Hospital, Ministry of Health
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Zhongshan University in Guangzhou
Guangzhou, Guangdong, China
The Third Affiliated Hospital of Zhongshan University in Guangzhou
Guangzhou, Guangdong, China
The Guangxi Zhuang Autonomous Region people's Hospital
Nanning, Guangxi, China
Guangzhou Shenzhen People's Hospital
Shenzhen, Guangzhou, China
Affiliated Hospital of Chengde Medical College
Chengde, Hebei, China
The first hospital of Handan city Hebei Province
Handan, Hebei, China
Hebei Hengshui international Heping Hospital
Hengshui, Hebei, China
Hebei Affiliated Hospital of North China Coal Medical University
Shijiazhuang, Hebei, China
Hebei Medical University Second Hospital
Shijiazhuang, Hebei, China
No.2 Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
The Third Affiliated Hospital of Inner Mongolia Medical College
Baotou, Inner Mongolia, China
Hospital of Inner Mongolia Autonomous Region
Hohhot, Inner Mongolia, China
Anshan Iron and Steel Company General Hospital
Anshan, Liaoning, China
The first hospital of Dalian Medical University
Dalian, Liaoning, China
Liaoning General Hospital of Shenyang Military Region
Shenyang, Liaoning, China
Shenyang Medical College affiliated Fengtian Hospital
Shenyang, Liaoning, China
Affiliated Hospital of Ningxia Medical University
Yinchuan, Ningxia, China
The Fourth Military Medical University, Xijing Hospital
Xi'an, Shan'xi, China
Shandong Jining Medical University Affiliated Hospital
Jining, Shandong, China
Shandong Medical College Affiliated Hospital of Qiingdao University
Qingdao, Shandong, China
Shandong Yantai city Yantai Mountain hospital
Yantai, Shandong, China
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, China
Second Military Medical University Changhai Hospital
Shanghai, Shanghai Municipality, China
Zhongshan Hospital Affiliated to Shanghai Fudan University
Shanghai, Shanghai Municipality, China
Shanxi Medical University Second Hospital
Taiyuan, Shanxi, China
The first hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Sichuan University, West China Hospital
Chengdu, Sichuan, China
The first hospital of Xinjiang Medical University
Ürümqi, Xinjiang, China
The Xinjiang Uygur Autonomous Region people's Hospital
Ürümqi, Xinjiang, China
Zhejiang Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, China
The First Affiliated Hospital of Wenzhou Medical College in Zhejiang
Wenzhou, Zhejiang, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen Wang, PhD,MD
Beijing Chao Yang Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of respiratory and critical care medicine
Study Record Dates
First Submitted
February 9, 2012
First Posted
February 13, 2012
Study Start
July 1, 2009
Primary Completion
July 1, 2012
Study Completion
December 1, 2012
Last Updated
February 14, 2012
Record last verified: 2012-02