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Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China

Information source: Beijing Chao Yang Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pulmonary Embolism; Thromboembolism

Intervention: rt-PA (Drug); rt-PA (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Beijing Chao Yang Hospital

Official(s) and/or principal investigator(s):
Chen WANG, Prof, Principal Investigator, Affiliation: Beijing Institute of Respiratory Medicine,Beijing Chao-Yang Hospital,Capital Medical University

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.

Clinical Details

Official title: 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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

The improvement of the right hart function on echocardiograms

Perfusion defect score of lung V/Q scans

Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment.

Secondary outcome:

Major or minor bleeding

PE recurrence

Death

Detailed description: Pulmonary thromboembolism (PTE) is a severe and common clinical problem with substantial morbidity and mortality both in US and in Europe. Used to be considered as a rare disease in China, PTE has been increasingly diagnosed in recent years due to the increased awareness and the improvement of imaging techniques. PTE is life threatening without proper intervention at the early onset. Effective treatment can decrease the mortality and the complication of chronic thromboembolic pulmonary hypertension (CTEPH). 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.

Eligibility

Minimum age: 18 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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

Locations and Contacts

Beijing Chaoyang Hospital, Capital University of Medical Sciences, Beijing, Beijing 100020, China

Beijing University People's Hospital, Beijing, Beijing, China

Peking Union Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing, China

The Omni-hospital of Air-force, Beijing, Beijing, 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, China

Shanghai Ruijin Hospital HUANG Shao-guang, Shanghai, Shanghai, China

The First Affiliated Hospital of Shanxi University, Tai-yuan, Shanxi, China

The Second Affiliated Hospital of Shanxi University, Tai-yuan, Shanxi, China

Tianjin Hospital of Medical Sciences, Tianjin, Tianjin, China

The Affiliated Hospital of Wenzhou Medical College, Wenzhou, Zhejiang, China

Zhejiang Shaoyifu Hospital, Hangzhou, Zhenjiang, China

Additional Information

Related publications:

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. 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. 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. Chinese.

Starting date: June 2002
Last updated: October 28, 2008

Page last updated: August 20, 2015

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