Pulmonary EmbolismPhase 4RESUPECNCT00968929
Recombinant Streptokinase Versus Urokinase in Pulmonary Embolism in China (RESUPEC)
A Phase 4 study testing Recombinant Streptokinase and Urokinase in people with Pulmonary Embolism and Pulmonary Thromboembolism, run by Beijing Chao Yang Hospital at 8 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism, Pulmonary Thromboembolism
- What is being tested?
- Recombinant Streptokinase and Urokinase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 8 sitesChina
- Study dates
- Jun 2006to May 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 17Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Beijing Institute of Respiratory Medicine, Beijing Chao-Yang hospital
Beijing, Beijing Municipality, 100020
Guangdong Institute of Respiratory Disease, Guangzhou Medical University,
Guangzhou, Guangdong, 510120
The Affiliated Hospital of Medical College Qingdao University
Qingdao, Shandong, 266003
The General Hospital of Shenyang Military Command
Shenyang, Liaoning, 110016
Shenzhen People's Hospital
Shenzhen, Guangdong, 518020
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052
Affiliated Hospital of Ningxia Medical University
Yinchuan, Ningxia, 750004
About this study
Official title: Efficacy and Safety Evaluation of Recombinant Streptokinase and Urokinase in the Treatment of Pulmonary Embolism: A Multi-Center, Randomized Controlled Trial in China
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.
Read the detailed description
Pulmonary embolism (PE) is a common cardiovascular illness. Massive PE is characterized with cardiogenic shock and/or persistent arterial hypotension. Submassive PE patients are defined with right ventricular dysfunction (RVD) identified by echocardiography or CT and the etc. The mortality of massive and submassive PE is higher than low-risk PE. PE has the mortality rate of >15% in the first 3 months after diagnosis. Thrombolytic treatment should be commenced as soon as possible after high-risk PE was diagnosed. Thrombolysis has been proved to be the most rapid and effective therapy to reduce the obstruction of pulmonary circulation and normalize hemodynamic parameters. The ultimate goals of thrombolytic therapy for this disease are to minimize early morbidity and mortality and to prevent recurrence without provoking excessive bleeding.
Currently, the choice of thrombolytic agents and regimens (SK, UK or rt-PA) is mostly based on personal or regional preferences. A novel dosing regimen of UK (3 million IU/2h, or 4400 IU/kg as a loading dose followed by 4400 IU/kg/h over 12h) and SK (1.5 million IU /2h) have been recommended in ESC guidelines. Considering lower body weight in Chinese population, a relative lower dosage UK-2h (20,000 IU/kg) regimen combined with low molecular weight heparin (LMWH) has been used in Chinese population. Our previous study has revealed that the efficacy and safety of UK-2h (20 000 IU/Kg) were similar with UK-12h (standard regimen) in Chinese patients. Thus the UK-2h (20,000 IU/Kg) became a popular and alternative choice in treating PE in China for its lower cost and convenience. Natural streptokinase (n-SK or SK) is an old thrombolytic agent. However, its immunogenicity lowers its safety and that constitute a concern among doctors. In recent years, as the development of gene engineering, r-SK was produced. R-SK has the advantage of not containing streptolysin and streptodornase unlike streptococci-derived n-SK which might make it safer theoretically. For its low cost, r-SK has been used to treat AMI especially in developing countries. In this study, the efficacy and safety between r-SK (1.5 million IU/2h) and UK-2h (20 000U/Kg) for treating acute PE will be compared. The study is conducted in patients with massive PE and submassive PE. The clinical efficacy, emboli dissolving efficacy and safety will be evaluated.
- Conditions
- Pulmonary Embolism, Pulmonary Thromboembolism
- Being tested
- Recombinant Streptokinase, Urokinase
- Keywords
- pulmonary embolism, thrombolysis, massive, submassive, recombinant streptokinase, urokinase
- Medical subject headings
- Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant StreptokinaseDrug
Recombinant streptokinase: 1.5 million IU continuously intravenous infusion for 2 hours
UrokinaseDrug
Urokinase: 20,000 IU/kg continuously intravenous infusion for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| r-SK group | Experimental | Recombinant streptokinase: 1.5 million IU continuously intravenous infusion for 2 hours Receives: Drug: Recombinant Streptokinase |
| UK group | Active comparator | Urokinase: 20,000 IU/kg continuously intravenous infusion for 2 hours Receives: Drug: Urokinase |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of the right ventricular function on echocardiogram
Measured: within the 1st, 14 days and 3 months
Quantitative computed tomographic pulmonary angiography (CTPA) score
Measured: 1st, 14 days and 3 months
The relief of symptoms
Measured: 2-4h, 1st, 4th , 7th, 10th, 14 days day and 3 months
Secondary outcomes (3)
Major or minor bleeding
Measured: 14 days and 3 months
Pulmonary embolism recurrence
Measured: 14 days and 3 months
Death
Measured: 14 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2009 (estimated)
- Study startJun 2006
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Beijing Chao Yang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Qingdao University, Tianjin Medical University General Hospital, General Hospital of Shenyang Military Region, Guangdong Institute of Respiratory Disease, The First Affiliated Hospital of Shanxi Medical University, Shenzhen People's Hospital, Affiliated Hospital of Ningxia Medical University
- Investigators
- Chen WANG, Prof, Principal investigator, Beijing Institute of Respiratory Medicine, Beijing-Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00968929
- Sponsor's protocol ID
- 2006BAI01A06
- Acronym
- RESUPEC
- Status last verified
- Aug 2009
- First submitted
- 28 Aug 2009
- Last updated
- 1 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17716753Zhu 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.
PubMed 17254482Zhu 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.
PubMed 17705052Yang 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.
PubMed 19833628
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of Recombinant Streptokinase and Urokinase in the Treatment of Pulmonary Embolism: A Multi-Center, Randomized Controlled Trial in China
- ClinicalTrials.gov ID
- NCT00968929
- Acronym / sponsor ID
- RESUPEC / 2006BAI01A06
- Conditions
- Pulmonary Embolism, Pulmonary Thromboembolism
- Keywords
- pulmonary embolism, thrombolysis, massive, submassive, recombinant streptokinase, urokinase
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Qingdao University, Tianjin Medical University General Hospital, General Hospital of Shenyang Military Region, Guangdong Institute of Respiratory Disease, The First Affiliated Hospital of Shanxi Medical University, Shenzhen People's Hospital, Affiliated Hospital of Ningxia Medical University
- Study start
- Jun 2006
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 31 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Pulmonary embolism (PE) is a common cardiovascular illness. Massive PE is characterized with cardiogenic shock and/or persistent arterial hypotension. Submassive PE patients are defined with right ventricular dysfunction (RVD) identified by echocardiography or CT and the etc. The mortality of massive and submassive PE is higher than low-risk PE. PE has the mortality rate of >15% in the first 3 months after diagnosis. Thrombolytic treatment should be commenced as soon as possible after high-risk PE was diagnosed. Thrombolysis has been proved to be the most rapid and effective therapy to reduce the obstruction of pulmonary circulation and normalize hemodynamic parameters. The ultimate goals of thrombolytic therapy for this disease are to minimize early morbidity and mortality and to prevent recurrence without provoking excessive bleeding.
Currently, the choice of thrombolytic agents and regimens (SK, UK or rt-PA) is mostly based on personal or regional preferences. A novel dosing regimen of UK (3 million IU/2h, or 4400 IU/kg as a loading dose followed by 4400 IU/kg/h over 12h) and SK (1.5 million IU /2h) have been recommended in ESC guidelines. Considering lower body weight in Chinese population, a relative lower dosage UK-2h (20,000 IU/kg) regimen combined with low molecular weight heparin (LMWH) has been used in Chinese population. Our previous study has revealed that the efficacy and safety of UK-2h (20 000 IU/Kg) were similar with UK-12h (standard regimen) in Chinese patients. Thus the UK-2h (20,000 IU/Kg) became a popular and alternative choice in treating PE in China for its lower cost and convenience. Natural streptokinase (n-SK or SK) is an old thrombolytic agent. However, its immunogenicity lowers its safety and that constitute a concern among doctors. In recent years, as the development of gene engineering, r-SK was produced. R-SK has the advantage of not containing streptolysin and streptodornase unlike streptococci-derived n-SK which might make it safer theoretically. For its low cost, r-SK has been used to treat AMI especially in developing countries. In this study, the efficacy and safety between r-SK (1.5 million IU/2h) and UK-2h (20 000U/Kg) for treating acute PE will be compared. The study is conducted in patients with massive PE and submassive PE. The clinical efficacy, emboli dissolving efficacy and safety will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| r-SK group | Experimental | Drug: Recombinant StreptokinaseRecombinant streptokinase: 1.5 million IU continuously intravenous infusion for 2 hours |
| UK group | Active comparator | Drug: UrokinaseUrokinase: 20,000 IU/kg continuously intravenous infusion for 2 hours |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant StreptokinaseRecombinant streptokinase: 1.5 million IU continuously intravenous infusion for 2 hours | Drug | r-SK group |
| UrokinaseUrokinase: 20,000 IU/kg continuously intravenous infusion for 2 hours | Drug | UK group |
Primary outcome
The improvement of the right ventricular function on echocardiogram
Time frame: within the 1st, 14 days and 3 months
Quantitative computed tomographic pulmonary angiography (CTPA) score
Time frame: 1st, 14 days and 3 months
The relief of symptoms
Time frame: 2-4h, 1st, 4th , 7th, 10th, 14 days day and 3 months
3 secondary outcomes
Major or minor bleeding
Time frame: 14 days and 3 months
Pulmonary embolism recurrence
Time frame: 14 days and 3 months
Death
Time frame: 14 days and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2009.
- Background: PubMed 17716753Zhu 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.
- Background: PubMed 17254482Zhu 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.
- Background: PubMed 17705052Zhu 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.
- Background: PubMed 19833628Yang 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chen WANG, Prof principal investigator
Beijing Institute of Respiratory Medicine, Beijing-Chao Yang Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Recombinant Streptokinase and Urokinase in people with Pulmonary Embolism and Pulmonary Thromboembolism, run by Beijing Chao Yang Hospital at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The improvement of the right ventricular function on echocardiogram (time frame: within the 1st, 14 days and 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00968929, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2009.