Pulmonary Embolism Clinical Trial
— RESUPECOfficial title:
Efficacy and Safety Evaluation of Recombinant Streptokinase and Urokinase in the Treatment of Pulmonary Embolism: A Multi-Center, Randomized Controlled Trial in China
Verified date | August 2009 |
Source | Beijing Chao Yang Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Food and Drug Administration |
Study type | Interventional |
Recombinant streptokinase (r-SK) is an effective thrombolytic agent developed with gene engineering. Its characteristics of high output and low production cost make it affordable in treating acute myocardial infarction (AMI) in developing countries. It is unclear whether r-SK can be used in patients with pulmonary embolism (PE). The aim of this study was to investigate the efficacy and safety of 1.5 million IU r-SK by 2 hours infusion and 20,000 IU/kg urokinase (UK) by 2 hours infusion in selected PE patients.
Status | Completed |
Enrollment | 83 |
Est. completion date | May 2009 |
Est. primary completion date | May 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Symptomatic PTE confirmed either by CTPA or by a high probability ventilation-perfusion lung scanning (V/Q scan). - Presented with hemodynamic instability (systolic blood pressure <90 mmHg or a fall in systolic blood pressure of more than 40 mmHg for at least 15 min, or cardiogenic shock) or associated with RVD identified by echocardiography or CT. - Symptoms deterioration less than 14 days before diagnosis. Exclusion Criteria: - Active bleeding or spontaneous intracranial hemorrhage in the preceding 6 months - Major surgery, organ biopsy or recent puncture of a non-compressible vessel in the preceding 2 weeks - Cerebral arterial thrombosis in the preceding 2 months - Gastro-intestinal bleeding in the preceding 10 days - Major trauma within the past 15 days - Neurosurgery or ophthalmologic operation in the preceding 1 month - 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 in the preceding 2 weeks - Infectious pericarditis or endocarditis - Severe hepatic and kidney dysfunction - Hemorrhagic retinopathy due to diabetes - A known bleeding disorder. - Chronic thromboembolic pulmonary hypertension (CTEPH) without new pulmonary thromboembolism (PTE) - Received streptokinase in the preceding 6 months - Infected by streptococcus in the preceding 1 month. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Beijing Institute of Respiratory Medicine, Beijing Chao-Yang hospital | Beijing | Beijing |
China | Guangdong Institute of Respiratory Disease, Guangzhou Medical University, | Guangzhou | Guangdong |
China | The Affiliated Hospital of Medical College Qingdao University | Qingdao | Shandong |
China | The General Hospital of Shenyang Military Command | Shenyang | Liaoning |
China | Shenzhen People's Hospital | Shenzhen | Guangdong |
China | The First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi |
China | Tianjin Medical University General Hospital | Tianjin | Tianjin |
China | Affiliated Hospital of Ningxia Medical University | Yinchuan | Ningxia |
Lead Sponsor | Collaborator |
---|---|
Beijing Chao Yang Hospital | General Hospital of Shenyang Military Region, Guangdong Institute of Respiratory Disease, Ningxia Medical University, Qingdao University, Shenzhen People's Hospital, The First Affiliated Hospital of Shanxi Medical University, Tianjin Medical University General Hospital |
China,
Yang Wang, Chen Wang, Yuanhua Yang, Baosen Pang. Effect of recombinant single-chain urokinase-type plasminogen activator on experimental pulmonary embolism. Clin Appl Thromb Hemost. 2010 Oct;16(5):537-42. doi: 10.1177/1076029609343003. Epub 2009 Oct 14. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The improvement of the right ventricular function on echocardiogram | within the 1st, 14 days and 3 months | No | |
Primary | Quantitative computed tomographic pulmonary angiography (CTPA) score | 1st, 14 days and 3 months | No | |
Primary | The relief of symptoms | 2-4h, 1st, 4th , 7th, 10th, 14 days day and 3 months | No | |
Secondary | Major or minor bleeding | 14 days and 3 months | Yes | |
Secondary | Pulmonary embolism recurrence | 14 days and 3 months | Yes | |
Secondary | Death | 14 days and 3 months | Yes |
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