Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China
Efficacy and Safety Evaluation of Low Dosage of Recombinant Tissue Plasminogen Activator (rt-PA) in the Treatment of Pulmonary Thromboembolism: A Multi-Center, Randomized Controlled Trial in China
2 other identifiers
interventional
118
1 country
23
Brief Summary
Recombinant tissue plasminogen activator (rt-PA) is currently the most commonly used thrombolytic drug in patients with pulmonary thromboembolism (PTE). Optimal dosing with maximal benefits and minimal risks is of great importance. Considering the lower body weight in general Chinese population, we compared the efficacy and safety of lower dose rt-PA 50mg/2h regimen with the FDA-approved rt-PA 100mg/2h regimen in selected PTE patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jun 2002
Longer than P75 for phase_4
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2006
CompletedFirst Submitted
Initial submission to the registry
October 21, 2008
CompletedFirst Posted
Study publicly available on registry
October 29, 2008
CompletedOctober 29, 2008
October 1, 2008
3.7 years
October 21, 2008
October 28, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
The improvement of the right hart function on echocardiograms
within the 1st 14 days
Perfusion defect score of lung V/Q scans
within the 1st 14 days
Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment.
within the 1st 14 days
Secondary Outcomes (3)
Major or minor bleeding
within 1st 14 days
PE recurrence
within the 1st 14 days
Death
within the 1st 14 days
Study Arms (2)
Group 1
ACTIVE COMPARATORrt-PA 100 mg continuous intravenous infusion for 2 hours
group 2
EXPERIMENTALrt-PA 50 mg continuous intravenous infusion for 2 hours
Interventions
rt-PA 100 mg continuous intravenous infusion for 2 hours
Eligibility Criteria
You may qualify if:
- age between 18 and 75
- symptomatic PE confirmed by: a high probability ventilation-perfusion lung scanning (V/Q scan) or the presence of intraluminal filling defect on spiral computed tomographic pulmonary angiography (CTPA)
- PTE patients with haemodynamic instability, or cardiogenic shock
- anatomic obstruction more than 2 lobes on CTPA, or defect more than 7 segments on V/Q scan combined with evidence of right ventricular dysfunction(RVD) and pulmonary hypertension on echocardiography
- written informed consent
You may not qualify if:
- active bleeding or spontaneous intracranial hemorrhage
- major surgery, organ biopsy or recent puncture of a non-compressible vessel less than 10 days
- cerebral arterial thrombosis within 2 months
- gastro-intestinal bleeding within 10 days
- major trauma within the past 15 days
- neurosurgery or ophthalmologic operation with 30 days
- uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg)
- recent external cardiac resuscitation manoeuvres
- platelet count \< 100 000/mm3 at admission
- pregnancy, puerperium or lactation with 2 weeks
- infectious pericarditis or endocarditis
- severe hepatic and kidney dysfunction
- hemorrhagic retinopathy due to diabetes
- a known bleeding disorder
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Beijing Chaoyang Hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, 100020, China
Beijing University People's Hospital
Beijing, Beijing Municipality, China
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China
The Omni-hospital of Air-force
Beijing, Beijing Municipality, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guangzhou Institute of Respiratory Disease
Guangdong, Guangzhou, China
The Second Affiliated Hospital of Hebei University
Shijiazhuang, Hebei, China
The First Affiliated Hospital of Zhengzhou University:
Zhengzhou, Henan, China
Shenyang Military Hospital
Shenyang, Liaoning, China
The Affiliated Hospital of Shenyang Medical University
Shenyang, Liaoning, China
The Affiliated Hospital of Ningxia Medical University
Yinchuang, Ningxia, China
Shangdong Yantaishan Hospital
Yantai, Shandong, China
Qilu Hospital of Shandong University
Jinan, Shangdong, China
The First Affiliated Hospital of Jining Medical College
Jinan, Shangdong, China
The First Affiliated Hospital of Qingdao University CHENG Zhao-zhong
Qingdao, Shangdong, China
Shanghai Hospital of Lung Disease
Shanghai, Shanghai Municipality, China
Shanghai Ruijin Hospital HUANG Shao-guang
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Shanxi University
Taiyuan, Shanxi, China
The Second Affiliated Hospital of Shanxi University
Taiyuan, Shanxi, China
Tianjin Hospital of Medical Sciences
Tianjin, Tianjin Municipality, China
The Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, China
Zhejiang Shaoyifu Hospital
Hangzhou, Zhenjiang, China
Related Publications (7)
Pang BS, Wang C, Lu Y, Yang YH, Xing GH, Mao YL, Huang XX, Zhai ZG. [Changes of blood coagulative and fibrinolytic system and function of pulmonary vascular endothelium after therapy in patients with acute pulmonary thromboembolism]. Zhonghua Yi Xue Za Zhi. 2007 Nov 20;87(43):3074-8. Chinese.
PMID: 18261355BACKGROUNDZhu L, Yang Y, Wu Y, Zhai Z, Wang C. Value of right ventricular dysfunction for prognosis in pulmonary embolism. Int J Cardiol. 2008 Jun 23;127(1):40-5. doi: 10.1016/j.ijcard.2007.06.093. Epub 2007 Aug 22.
PMID: 17716753BACKGROUNDZhu L, Wang C, Yang Y, Wu Y, Zhai Z, Dai H, Pang B, Tong Z. Value of transthoracic echocardiography in therapy regimens evaluation in pulmonary embolism. J Thromb Thrombolysis. 2008 Dec;26(3):251-6. doi: 10.1007/s11239-007-0087-8. Epub 2007 Aug 21.
PMID: 17705052BACKGROUNDZhu L, Yang YH, Wu YF, Zhai ZG, Wang C; National Project of the Diagnosis and Treatment Strategies for Pulmonary Thromboembolism investigators. Value of transthoracic echocardiography combined with cardiac troponin I in risk stratification in acute pulmonary thromboembolism. Chin Med J (Engl). 2007 Jan 5;120(1):17-21.
PMID: 17254482BACKGROUNDZhai ZG, Wang C, Yang YH, Pang BS, Xiao B, Liu YM, Mao YL, Weng XZ. [Relationship between polymorphisms of plasminogen activator inhibitor-1 promoter gene and pulmonary thromboembolism in Chinese Han population]. Zhonghua Yi Xue Za Zhi. 2006 May 23;86(19):1313-7. Chinese.
PMID: 16796899BACKGROUNDWang C, Cheng XS, Zhong NS. [Promoting the clinical and research work on pulmonary thromboembolism in China]. Zhonghua Jie He He Hu Xi Za Zhi. 2004 Nov;27(11):721-2. No abstract available. Chinese.
PMID: 15634378BACKGROUNDWang C, Zhai Z, Yang Y, Wu Q, Cheng Z, Liang L, Dai H, Huang K, Lu W, Zhang Z, Cheng X, Shen YH; China Venous Thromboembolism (VTE) Study Group. Efficacy and safety of low dose recombinant tissue-type plasminogen activator for the treatment of acute pulmonary thromboembolism: a randomized, multicenter, controlled trial. Chest. 2010 Feb;137(2):254-62. doi: 10.1378/chest.09-0765. Epub 2009 Sep 9.
PMID: 19741062DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chen WANG, Prof
Beijing Institute of Respiratory Medicine,Beijing Chao-Yang Hospital,Capital Medical University
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 21, 2008
First Posted
October 29, 2008
Study Start
June 1, 2002
Primary Completion
February 1, 2006
Study Completion
February 1, 2006
Last Updated
October 29, 2008
Record last verified: 2008-10