Pulmonary EmbolismPhase 4NCT00781378
Low Dosage of rt-PA in the Treatment of Pulmonary Thromboembolism in China
A Phase 4 study testing rt-PA in people with Pulmonary Embolism and Thromboembolism, run by Beijing Chao Yang Hospital at 23 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Embolism, Thromboembolism
- What is being tested?
- rt-PA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 23 sitesChina
- Study dates
- Jun 2002to Feb 2006
- 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
- 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
Who cannot join
- 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
Show all 14Show 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 with 2 weeks
- infectious pericarditis or endocarditis
- severe hepatic and kidney dysfunction
- hemorrhagic retinopathy due to diabetes
- a known bleeding disorder
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
China23 sites
Beijing Chaoyang Hospital, Capital University of Medical Sciences
Beijing, Beijing Municipality, 100020
Beijing University People's Hospital
Beijing, Beijing Municipality
Peking Union Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality
The Omni-hospital of Air-force
Beijing, Beijing Municipality
Guangzhou Institute of Respiratory Disease
Guangdong, Guangzhou
Zhejiang Shaoyifu Hospital
Hangzhou, Zhenjiang
Qilu Hospital of Shandong University
Jinan, Shangdong
The First Affiliated Hospital of Jining Medical College
Jinan, Shangdong
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi
The First Affiliated Hospital of Qingdao University CHENG Zhao-zhong
Qingdao, Shangdong
Shanghai Hospital of Lung Disease
Shanghai, Shanghai Municipality
Shanghai Ruijin Hospital HUANG Shao-guang
Shanghai, Shanghai Municipality
Shenyang Military Hospital
Shenyang, Liaoning
The Affiliated Hospital of Shenyang Medical University
Shenyang, Liaoning
Shenzhen People's Hospital
Shenzhen, Guangdong
The Second Affiliated Hospital of Hebei University
Shijiazhuang, Hebei
The First Affiliated Hospital of Shanxi University
Taiyuan, Shanxi
The Second Affiliated Hospital of Shanxi University
Taiyuan, Shanxi
Tianjin Hospital of Medical Sciences
Tianjin, Tianjin Municipality
The Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang
Shangdong Yantaishan Hospital
Yantai, Shandong
The Affiliated Hospital of Ningxia Medical University
Yinchuang, Ningxia
The First Affiliated Hospital of Zhengzhou University:
Zhengzhou, Henan
About this study
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
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.
Read the 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.
- Conditions
- Pulmonary Embolism, Thromboembolism
- Being tested
- rt-PA
- Keywords
- Thrombolytic therapy, Recombinant tissue plasminogen activator, Efficacy, Safety
- Medical subject headings
- Pulmonary Embolism, Thromboembolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rt-PADrug
Also called Recombinant tissue plasminogen activator
rt-PA 100 mg continuous intravenous infusion for 2 hours
rt-PADrug
Also called Recombinant tissue plasminogen activator
rt-PA 50 mg continuous intravenous infusion for 2 hours
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | rt-PA 100 mg continuous intravenous infusion for 2 hours Receives: Drug: rt-PA |
| group 2 | Experimental | rt-PA 50 mg continuous intravenous infusion for 2 hours Receives: Drug: rt-PA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The improvement of the right hart function on echocardiograms
Measured: within the 1st 14 days
Perfusion defect score of lung V/Q scans
Measured: within the 1st 14 days
Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment.
Measured: within the 1st 14 days
Secondary outcomes (3)
Major or minor bleeding
Measured: within 1st 14 days
PE recurrence
Measured: within the 1st 14 days
Death
Measured: within the 1st 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startJun 2002
- Primary completionFeb 2006
- Study completionFeb 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Chen WANG, Prof, Principal investigator, Beijing Institute of Respiratory Medicine,Beijing Chao-Yang Hospital,Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781378
- Sponsor's protocol ID
- 2001BA703B13
- Other IDs
- 2004BA703B07
- Status last verified
- Oct 2008
- First submitted
- 21 Oct 2008
- Last updated
- 29 Oct 2008
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 18261355Zhu 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, 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 17705052Zhu 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 17254482Zhai 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.
PubMed 16796899Wang 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.
PubMed 15634378Wang 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.
PubMed 19741062
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00781378
- Acronym / sponsor ID
- 2001BA703B13
- Conditions
- Pulmonary Embolism, Thromboembolism
- Keywords
- Thrombolytic therapy, Recombinant tissue plasminogen activator, Efficacy, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- Feb 2006 (actual)
- Study completion
- Feb 2006 (actual)
- First posted
- 29 Oct 2008 (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 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: rt-PArt-PA 100 mg continuous intravenous infusion for 2 hours |
| group 2 | Experimental | Drug: rt-PArt-PA 50 mg continuous 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 (5 listed)
- 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
Key exclusion criteria (14 listed)
- 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
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 |
|---|---|---|
| rt-PAAlso: Recombinant tissue plasminogen activatorrt-PA 100 mg continuous intravenous infusion for 2 hours | Drug | Group 1 |
| rt-PAAlso: Recombinant tissue plasminogen activatorrt-PA 50 mg continuous intravenous infusion for 2 hours | Drug | group 2 |
Primary outcome
The improvement of the right hart function on echocardiograms
Time frame: within the 1st 14 days
Perfusion defect score of lung V/Q scans
Time frame: within the 1st 14 days
Quantitative computed tomographic pulmonary angiography (CTPA) score on 2d, 14d after treatment.
Time frame: within the 1st 14 days
3 secondary outcomes
Major or minor bleeding
Time frame: within 1st 14 days
PE recurrence
Time frame: within the 1st 14 days
Death
Time frame: within the 1st 14 days
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 29 Oct 2008.
- Background: PubMed 18261355Pang 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.
- 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 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 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 16796899Zhai 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.
- Background: PubMed 15634378Wang 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.
- Derived from this study: PubMed 19741062Wang 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.
Related trials for Pulmonary Embolism
RecruitingObservational study
Study of the Long-Term Safety and Outcomes of Treating Pulmonary Embolism With the Indigo Aspiration System
Pulmonary Embolism
Not yet recruiting
Pilot Study Evaluating Catheter Directed Thrombolysis Device in Acute Intermediate Risk Pulmonary Embolism
Pulmonary Embolism (PE), Pulmonary Embolism With Right Ventricle Enlargement
RecruitingObservational study
Inari VISION Registry
Pulmonary Embolism
RecruitingPhase 3
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
Cancer-Associated Thrombosis (CAT)
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,Capital Medical University
23 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 rt-PA in people with Pulmonary Embolism and Thromboembolism, run by Beijing Chao Yang Hospital at 23 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 5 inclusion and 14 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 29 Oct 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 hart function on echocardiograms (time frame: within the 1st 14 days). 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 NCT00781378, which also lists 7 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 29 Oct 2008.