Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD
NCT ID: NCT01531829
Last Updated: 2012-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
460 participants
INTERVENTIONAL
2009-07-31
2012-12-31
Brief Summary
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Detailed Description
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In our previous study, we found that low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had less bleeding tendency than the 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.
In this prospective, multicenter, randomized, control study, we compare low dose rt-PA plus LMWH vs. LMWH alone in acute normotensive pulmonary embolism patients with RV dysfunction. The primary efficacy outcome is the composite of death from any cause or treatment failure, improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs within 7 days of randomization. Second efficacy outcome is the recurrence of pulmonary embolism and deep venous thrombosis. Safety outcomes include serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes, also include mild bleeding. In addition, 90-day clinical and echocardiographic follow-up will be performed, the recurrence of pulmonary embolism and deep venous thrombosis will be recorded. The study is expected to enroll approximately 460 patients.
By determining the benefits vs risks of Low dose rt-PA plus LMWH compared with LMWH alone for the treatment in submassive or intermediate-risk PE, this trial is expected to reveal the worth of Low dose rt-PA plus LMWH treatment and what kind of PE patients are suitable for thrombolysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Low dose (50mg/2h) rt-PA plus LMWH
Low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) plus low molecular weight heparin(LMWH)regimen
Recombinant tissue plasminogen activator (rt-PA)
Low dose (50mg/2h) rt-PA plus LMWH
LMWH
Low molecular weight heparin
Low Molecular Weight Heparin
0.1ml/10kg,q12h,5-7 days
Interventions
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Recombinant tissue plasminogen activator (rt-PA)
Low dose (50mg/2h) rt-PA plus LMWH
Low Molecular Weight Heparin
0.1ml/10kg,q12h,5-7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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
3. Hemodynamic stability, diastolic pressure\>90mmHg.
4. 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
Exclusion Criteria
2. Active internal bleeding and spontaneous intracranial hemorrhage in preceding 6 months
3. Major surgery, organ biopsy or non-compressible punctures within 2 weeks
4. Ischemic stroke occurred within 2 months
5. Gastrointestinal bleeding within 10 days
6. Severe trauma occurred within15 days
7. Neurosurgery or eye surgery within 1 months
8. Severe hypertension difficult to control (systolic blood pressure\>180mmHg or diastolic blood pressure\>110mmHg)
9. Cardiopulmonary resuscitation
10. Platelet count less than 100×109 / L
11. Pregnancy, or within 2 week post partum
12. Infective endocarditis; left atrial thrombus; aneurysm
13. Serious liver and kidney dysfunction
14. Diabetic hemorrhagic retinopathy
15. Suffering with bleeding disorders
16. Chronic thromboembolic pulmonary hypertension
17. Moderate to severe chronic obstructive pulmonary disease (COPD).
18 Years
75 Years
ALL
No
Sponsors
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Ministry of Science and Technology of the People´s Republic of China
OTHER_GOV
Beijing Chao Yang Hospital
OTHER
Responsible Party
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Chen WANG
Professor of respiratory and critical care medicine
Principal Investigators
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Chen Wang, PhD,MD
Role: PRINCIPAL_INVESTIGATOR
Beijing Chao Yang Hospital
Locations
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Beijing Chao Yang Hospial
Beijing, Beijing Municipality, 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
Countries
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Central Contacts
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Facility Contacts
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Yongxiang Zhang, MD
Role: primary
Zhihong Liu, MD
Role: primary
Baomin Fang, MD
Role: primary
Mian Zeng, MD
Role: primary
yulin Zhou, MD
Role: primary
shengze Long, MD
Role: primary
Chen Qiu, MD
Role: primary
Guifang Pang, MD
Role: primary
Jinghui Ye, MD
Role: primary
Zhaobo Cui, MD
Role: primary
Baibing Liu, MD
Role: primary
Yadong Yuan, MD
Role: primary
Hong Chen, MD
Role: primary
Ling Wang, MD
Role: primary
Weilie Wang, MD
Role: primary
Hongyu Zhou, MD
Role: primary
Yingqun Ji, MD
Role: primary
Liang Shi, MD
Role: primary
Shuyue Xia, MD
Role: primary
Zheng Yang, MD
Role: primary
Shengqing Li, PhD, MD
Role: primary
Luning Jiang, MD
Role: primary
Li Tong, MD
Role: primary
Lijun Kang, MD
Role: primary
Guochao Shi, MD
Role: primary
Wei Zhang, MD
Role: primary
Jinjun Jiang, MD
Role: primary
Xu Wang, MD
Role: primary
Xiaoyun Hu, MD
Role: primary
Qun Yi, MD
Role: primary
Zaiyi Wang, MD
Role: primary
Ying Chen, MD
Role: primary
Guofeng Ma, MD
Role: primary
Yupeng Xie, MD
Role: primary
Other Identifiers
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BJCYH1893
Identifier Type: -
Identifier Source: org_study_id
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