Pulmonary ThromboembolismsPhase 4NCT01531829
Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD
A Phase 4 study testing Recombinant tissue plasminogen activator (rt-PA) and Low Molecular Weight Heparin in people with Pulmonary Thromboembolisms and Pulmonary Embolism, run by Beijing Chao Yang Hospital at 35 sites in China.
Trial summary
In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus low… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pulmonary Thromboembolisms, Pulmonary Embolism
- What is being tested?
- Recombinant tissue plasminogen activator (rt-PA) and Low Molecular Weight Heparin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 460 participants
- Where
- 35 sitesChina
- Study dates
- Jul 2009to Dec 2012
- 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
- 18 y≤Age≤75y
- Acute PE (first symptoms occurred 14 d or less before randomization) confirmed by lung scan, or a positive computed tomographic pulmonary angiogram, or a positive selective pulmonary angiogram
- Hemodynamic stability, diastolic pressure>90mmHg.
- RV dysfunction confirmed by echocardiography (≥1 criterion), except left-side heart disease, congenital heart disease and mitral valve disease.
- Increase of the right ventricle showed presented with RV end-diastolic anteroposterior diameter >25 mm, Right/left ventricular end-diastolic diameter >1 (apical or subcostal 4-chamber view) or Right/left ventricular end-diastolic anteroposterior diameter >0.5
- Hypokinesis of RV-free wall (range of motion less than 5 mm)
- Tricuspid regurgitation pressure >30mmHg
Who cannot join
- RV anterior wall thickness > 5mm confirmed by echocardiography
- Active internal bleeding and spontaneous intracranial hemorrhage in preceding 6 months
- Major surgery, organ biopsy or non-compressible punctures within 2 weeks
- Ischemic stroke occurred within 2 months
- Gastrointestinal bleeding within 10 days
- Severe trauma occurred within15 days
Show all 17Show fewer
- Neurosurgery or eye surgery within 1 months
- Severe hypertension difficult to control (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg)
- Cardiopulmonary resuscitation
- Platelet count less than 100×109 / L
- Pregnancy, or within 2 week post partum
- Infective endocarditis; left atrial thrombus; aneurysm
- Serious liver and kidney dysfunction
- Diabetic hemorrhagic retinopathy
- Suffering with bleeding disorders
- Chronic thromboembolic pulmonary hypertension
- Moderate to severe chronic obstructive pulmonary disease (COPD).
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
China35 sites, 35 recruiting
- Recruiting
Anshan Iron and Steel Company General Hospital
Anshan, Liaoning
Hongyu Zhou, MD
Hongyu Zhou, MD
- Recruiting
The Third Affiliated Hospital of Inner Mongolia Medical College
Baotou, Inner Mongolia
Ling Wang, MD
Jingping Yang, MD
- Recruiting
Beijing Chao Yang Hospial
Beijing, Beijing Municipality, 100020
Yuanhua Yang, PhD,MD, 8610-65060167, yyh1031@sina.com
Chen Wang, PhD,MD
- Recruiting
Beijing Daxing People's Hospital
Beijing, Beijing Municipality
Yongxiang Zhang, MD
Yongxiang Zhang, MD
- Recruiting
Beijing Fuwai Hospital
Beijing, Beijing Municipality
Zhihong Liu, MD
Zhihong Liu, MD
- Not yet recruiting
Beijing Hospital, Ministry of Health
Beijing, Beijing Municipality
Baomin Fang, MD
Baoming Fang, MD
- Recruiting
Affiliated Hospital of Chengde Medical College
Chengde, Hebei
Guifang Pang, MD
Qing Zhang, MD
- Recruiting
Sichuan University, West China Hospital
Chengdu, Sichuan
Qun Yi, MD
Qun Yi, MD
- Recruiting
The first hospital of Dalian Medical University
Dalian, Liaoning
Yingqun Ji, MD
Zhonghe Zhang, MD
- Recruiting
The First Affiliated Hospital of Zhongshan University in Guangzhou
Guangzhou, Guangdong
Mian Zeng, MD
Canmao Xie, MD
- Recruiting
The Third Affiliated Hospital of Zhongshan University in Guangzhou
Guangzhou, Guangdong
yulin Zhou, MD
Tiantuo Zhang, MD
- Recruiting
The first hospital of Handan city Hebei Province
Handan, Hebei
Jinghui Ye, MD
Jinghui Ye, MD
- Recruiting
Zhejiang Sir Run Run Shaw Hospital
Hangzhou, Zhejiang
Guofeng Ma, MD
Kejing Ying, MD
- Recruiting
No.2 Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Hong Chen, MD
Hong Chen, MD
- Recruiting
Hebei Hengshui international Heping Hospital
Hengshui, Hebei
Zhaobo Cui, MD
Zhaobo Cui, MD
- Recruiting
Hospital of Inner Mongolia Autonomous Region
Hohhot, Inner Mongolia
Weilie Wang, MD
Wenting Zhang, MD
- Recruiting
Shandong Jining Medical University Affiliated Hospital
Jining, Shandong
Luning Jiang, MD
Luning Jiang, MD
- Recruiting
The Guangxi Zhuang Autonomous Region people's Hospital
Nanning, Guangxi
shengze Long, MD
Zhiqiang Qing, PhD,MD
- Recruiting
Shandong Medical College Affiliated Hospital of Qiingdao University
Qingdao, Shandong
Li Tong, MD
Zhaozhong Cheng, MD
- Recruiting
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality
Guochao Shi, MD
Shaoguang Huang, MD
- Recruiting
Second Military Medical University Changhai Hospital
Shanghai, Shanghai Municipality
Wei Zhang, MD
Qiang Li, MD
- Recruiting
Zhongshan Hospital Affiliated to Shanghai Fudan University
Shanghai, Shanghai Municipality
Jinjun Jiang, MD
Chunxue Bai, PhD,MD
- Recruiting
Liaoning General Hospital of Shenyang Military Region
Shenyang, Liaoning
Liang Shi, MD
Zhuang Ma, MD
- Recruiting
Shenyang Medical College affiliated Fengtian Hospital
Shenyang, Liaoning
Shuyue Xia, MD
Shuyue Xia, MD
- Recruiting
Guangzhou Shenzhen People's Hospital
Shenzhen, Guangzhou
Chen Qiu, MD
Chen Qiu, MD
- Recruiting
Hebei Affiliated Hospital of North China Coal Medical University
Shijiazhuang, Hebei
Baibing Liu, MD
Hongyang Wang, MD
- Recruiting
Hebei Medical University Second Hospital
Shijiazhuang, Hebei
Yadong Yuan, MD
Yadong Yuan, MD
- Recruiting
Shanxi Medical University Second Hospital
Taiyuan, Shanxi
Xu Wang, MD
Zhuola Liu, MD
- Recruiting
The first hospital of Shanxi Medical University
Taiyuan, Shanxi
Xiaoyun Hu, MD
Yongcheng Du, MD
- Recruiting
The first hospital of Xinjiang Medical University
Ürümqi, Xinjiang
Zaiyi Wang, MD
Zaiyi Wang, MD
- Recruiting
The Xinjiang Uygur Autonomous Region people's Hospital
Ürümqi, Xinjiang
Ying Chen, MD
Xiaohong Yang, MD
- Recruiting
The First Affiliated Hospital of Wenzhou Medical College in Zhejiang
Wenzhou, Zhejiang
Yupeng Xie, MD
Liangxing Wang, MD
- Recruiting
The Fourth Military Medical University, Xijing Hospital
Xi'an, Shan'xi
Shengqing Li, PhD, MD
Changgui Wu, MD
- Recruiting
Shandong Yantai city Yantai Mountain hospital
Yantai, Shandong
Lijun Kang, MD
Shudong Zhang, MD
- Recruiting
Affiliated Hospital of Ningxia Medical University
Yinchuan, Ningxia
Zheng Yang, MD
Jin Zhang, MD
About this study
Official title: Low Dose Rt-PA Plus LMWH Compared With LMWH Alone for the Treatment of Normotensive Pulmonary Embolism Patients With Acute RV Dysfunction: A Randomized,Multi-Center,Controlled Trial
In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events. The aim of the study is to compare thrombolytic treatment with LMWH in patients with acute normotensive PE with right ventricular dysfunction(RVD).
Read the detailed description
In acute pulmonary embolism (PE), normotensive patients with acute RV dysfunction on echocardiography or computed tomography and with myocardial troponin elevation may have an adverse outcome. Thrombolysis rapidly reverses RV pressure overload in PE, but it increases the possibility of bleeding and it remains unclear whether it may improve the early or long-term clinical outcome of these selected normotensive patients.
In our previous study, we found that low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had less bleeding tendency than the 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus Low Molecular Weight Heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events.
In this prospective, multicenter, randomized, control study, we compare low dose rt-PA plus LMWH vs. LMWH alone in acute normotensive pulmonary embolism patients with RV dysfunction. The primary efficacy outcome is the composite of death from any cause or treatment failure, improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs within 7 days of randomization. Second efficacy outcome is the recurrence of pulmonary embolism and deep venous thrombosis. Safety outcomes include serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes, also include mild bleeding. In addition, 90-day clinical and echocardiographic follow-up will be performed, the recurrence of pulmonary embolism and deep venous thrombosis will be recorded. The study is expected to enroll approximately 460 patients.
By determining the benefits vs risks of Low dose rt-PA plus LMWH compared with LMWH alone for the treatment in submassive or intermediate-risk PE, this trial is expected to reveal the worth of Low dose rt-PA plus LMWH treatment and what kind of PE patients are suitable for thrombolysis.
- Conditions
- Pulmonary Thromboembolisms, Pulmonary Embolism
- Being tested
- Recombinant tissue plasminogen activator (rt-PA), Low Molecular Weight Heparin
- Keywords
- pulmonary embolism, right ventricular dysfunction, Thrombolysis, Heparin
- Medical subject headings
- Pulmonary Embolism, Ventricular Dysfunction, Right
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant tissue plasminogen activator (rt-PA)Drug
Also called rt-PA
Low dose (50mg/2h) rt-PA plus LMWH
Low Molecular Weight HeparinDrug
Also called Nadroparin
0.1ml/10kg,q12h,5-7 days
| Study group | Role | What they receive |
|---|---|---|
| Low dose (50mg/2h) rt-PA plus LMWH | Experimental | Low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) plus low molecular weight heparin(LMWH)regimen Receives: Drug: Recombinant tissue plasminogen activator (rt-PA) |
| LMWH | Active comparator | Low molecular weight heparin Receives: Drug: Low Molecular Weight Heparin |
What is being measured
The primary outcome is the main question the study is designed to answer.
the composite end point of death from any cause or treatment failure,recurrence of VTE
Measured: 7 days
improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs
Measured: 7 days
serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes
Measured: 7 days
clinical relevant non-major bleedings
Measured: 7 days
Secondary outcomes (4)
the composite end point of death from any cause or treatment failure,recurrence of VTE
Measured: 3 months and 6 months
improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs
Measured: 3 months and 6 months
serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes
Measured: 3 months and 6 months
clinical relevant non-major bleedings
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJul 2009
- Primary completionJul 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary ThromboembolismsStudies 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
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chao Yang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Responsible party
- Principal investigator, Chen WANG, Beijing Chao Yang Hospital
- Investigators
- Chen Wang, PhD,MD, Principal investigator, Beijing Chao Yang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531829
- Sponsor's protocol ID
- BJCYH1893
- Status last verified
- Feb 2012
- First submitted
- 9 Feb 2012
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Rt-PA Plus LMWH Compared With LMWH Alone for the Treatment of Normotensive Pulmonary Embolism Patients With Acute RV Dysfunction: A Randomized,Multi-Center,Controlled Trial
- ClinicalTrials.gov ID
- NCT01531829
- Acronym / sponsor ID
- BJCYH1893
- Conditions
- Pulmonary Thromboembolisms, Pulmonary Embolism
- Keywords
- pulmonary embolism, right ventricular dysfunction, Thrombolysis, Heparin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Beijing Chao Yang HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology of the People´s Republic of China
- Study start
- Jul 2009
- Primary completion
- Jul 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 13 Feb 2012 (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.
In selected patients with acute pulmonary embolism(PE), low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had been reported to have less bleeding tendency than the FDA-approved rt-PA 100mg/2h regimen 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus low molecular weight heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events. The aim of the study is to compare thrombolytic treatment with LMWH in patients with acute normotensive PE with right ventricular dysfunction(RVD).
Detailed description
In acute pulmonary embolism (PE), normotensive patients with acute RV dysfunction on echocardiography or computed tomography and with myocardial troponin elevation may have an adverse outcome. Thrombolysis rapidly reverses RV pressure overload in PE, but it increases the possibility of bleeding and it remains unclear whether it may improve the early or long-term clinical outcome of these selected normotensive patients.
In our previous study, we found that low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) regimen had less bleeding tendency than the 100mg/2h regimen (3% vs.10%), it is worthwhile to reveal whether low dose rt-PA plus Low Molecular Weight Heparin (LMWH) can rapidly reverses RV pressure overload in PE, but not increase bleeding and other adverse events.
In this prospective, multicenter, randomized, control study, we compare low dose rt-PA plus LMWH vs. LMWH alone in acute normotensive pulmonary embolism patients with RV dysfunction. The primary efficacy outcome is the composite of death from any cause or treatment failure, improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs within 7 days of randomization. Second efficacy outcome is the recurrence of pulmonary embolism and deep venous thrombosis. Safety outcomes include serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes, also include mild bleeding. In addition, 90-day clinical and echocardiographic follow-up will be performed, the recurrence of pulmonary embolism and deep venous thrombosis will be recorded. The study is expected to enroll approximately 460 patients.
By determining the benefits vs risks of Low dose rt-PA plus LMWH compared with LMWH alone for the treatment in submassive or intermediate-risk PE, this trial is expected to reveal the worth of Low dose rt-PA plus LMWH treatment and what kind of PE patients are suitable for thrombolysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low dose (50mg/2h) rt-PA plus LMWH | Experimental | Drug: Recombinant tissue plasminogen activator (rt-PA)Low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) plus low molecular weight heparin(LMWH)regimen |
| LMWH | Active comparator | Drug: Low Molecular Weight HeparinLow molecular weight heparin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 y≤Age≤75y
- Acute PE (first symptoms occurred 14 d or less before randomization) confirmed by lung scan, or a positive computed tomographic pulmonary angiogram, or a positive selective pulmonary angiogram
- Hemodynamic stability, diastolic pressure>90mmHg.
- RV dysfunction confirmed by echocardiography (≥1 criterion), except left-side heart disease, congenital heart disease and mitral valve disease.
Key exclusion criteria (17 listed)
- RV anterior wall thickness > 5mm confirmed by echocardiography
- Active internal bleeding and spontaneous intracranial hemorrhage in preceding 6 months
- Major surgery, organ biopsy or non-compressible punctures within 2 weeks
- Ischemic stroke occurred within 2 months
- Gastrointestinal bleeding within 10 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 tissue plasminogen activator (rt-PA)Also: rt-PALow dose (50mg/2h) rt-PA plus LMWH | Drug | Low dose (50mg/2h) rt-PA plus LMWH |
| Low Molecular Weight HeparinAlso: Nadroparin0.1ml/10kg,q12h,5-7 days | Drug | LMWH |
Primary outcome
the composite end point of death from any cause or treatment failure,recurrence of VTE
Time frame: 7 days
improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs
Time frame: 7 days
serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes
Time frame: 7 days
clinical relevant non-major bleedings
Time frame: 7 days
4 secondary outcomes
the composite end point of death from any cause or treatment failure,recurrence of VTE
Time frame: 3 months and 6 months
improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs
Time frame: 3 months and 6 months
serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes
Time frame: 3 months and 6 months
clinical relevant non-major bleedings
Time frame: 3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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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, PhD,MD principal investigator
Beijing Chao Yang Hospital
35 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 tissue plasminogen activator (rt-PA) and Low Molecular Weight Heparin in people with Pulmonary Thromboembolisms and Pulmonary Embolism, run by Beijing Chao Yang Hospital at 35 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 7 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: status not confirmed, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen Wang, PhD,MD (8610-85231893, cyh-birm@263.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the composite end point of death from any cause or treatment failure,recurrence of VTE (time frame: 7 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Feb 2012.