Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China
NCT ID: NCT00781378
Last Updated: 2008-10-29
Study Results
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Basic Information
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COMPLETED
PHASE4
118 participants
INTERVENTIONAL
2002-06-30
2006-02-28
Brief Summary
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Detailed Description
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Recombinant tissue-type plasminogen activator (rt-PA) is currently the most commonly used drug for PTE thrombolysis. Like most thrombolytic medications, rt-PA carries a risk of significant bleeding, which is dose dependent. Thus, optimal dosing that can maximize benefits and minimize risks is of great importance. There is substantial controversy and debate regarding the optimal rt-PA dosage for thrombolytic therapy and whether the same dose should be used in all patients. Low dose of intravenous rt-PA for thrombolysis after acute myocardial infarction (AMI) had been suggested by previous studies. Experimental and clinical studies have indicated that a lower dose of rt-PA bolus may be potentially safer, and yet equally effective then the 2-h 100 mg rt-PA continuous infusion for PTE.
Considering lower body weight in Chinese population, a lower dose of 50mg rt-PA/2h may exhibit similar efficacy and safety as 100mg/2-h rt-PA for treating acute PTE in this population. We, therefore, compared these two regimens in a multi-center, randomized, controlled trial. The efficacy was assessed by the improvement of the right ventricular function on echocardiograms, perfusion defect score of lung V/Q scans or quantitative computed tomographic (CT) evaluation, safety was evaluated by incidence of major or minor bleeding, death rate, and PTE recurrence on 24h,14d after treatment.
110 patients will be randomized in the study. The patients included in the study will be randomized, in a double blind fashion, to receive rt-PA 100mg 2h (55 patients) or rt-PA50mg 2h(55 patients).Study treatment should be administered within 72 hours from echocardiography. Echocardiography will be repeated at 24 hours and 14 days from rt-PA injection. A Follow-up visit at 14 days from randomization will include: clinical history, physical examination and ECG and an echocardiographic examination CTPA and V/Q scan.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group 1
rt-PA 100 mg continuous intravenous infusion for 2 hours
rt-PA
rt-PA 100 mg continuous intravenous infusion for 2 hours
group 2
rt-PA 50 mg continuous intravenous infusion for 2 hours
rt-PA
rt-PA 50 mg continuous intravenous infusion for 2 hours
Interventions
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rt-PA
rt-PA 100 mg continuous intravenous infusion for 2 hours
rt-PA
rt-PA 50 mg continuous intravenous infusion for 2 hours
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Beijing Chao Yang Hospital
OTHER
Responsible Party
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Beijing Chao-Yang Hospital
Principal Investigators
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Chen WANG, Prof
Role: PRINCIPAL_INVESTIGATOR
Beijing Institute of Respiratory Medicine,Beijing Chao-Yang Hospital,Capital Medical University
Locations
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Beijing Chaoyang Hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, 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
Countries
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References
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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.
Zhu 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.
Zhu 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.
Zhu 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.
Zhai 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.
Wang 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.
Wang 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.
Other Identifiers
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2004BA703B07
Identifier Type: -
Identifier Source: secondary_id
2001BA703B13
Identifier Type: -
Identifier Source: org_study_id