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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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.

Chen Wang, PhD,MD contact

8610-85231893

cyh-birm@263.net

Tuguang Kuang, PhD,MD contact

8610-85231451

ktg2004@sina.com

35 sites in 1 country

China35 sites, 35 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

    Recruiting
  • Beijing Hospital, Ministry of Health

    Beijing, Beijing Municipality

    Baomin Fang, MD

    Baoming Fang, MD

    Not yet 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

    Recruiting

Other trials in China

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.

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 groups in NCT01531829
Study groupRoleWhat they receive
Low dose (50mg/2h) rt-PA plus LMWHExperimentalLow dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) plus low molecular weight heparin(LMWH)regimen
Receives: Drug: Recombinant tissue plasminogen activator (rt-PA)
LMWHActive comparatorLow 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.

  1. the composite end point of death from any cause or treatment failure,recurrence of VTE

    Measured: 7 days

  2. improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs

    Measured: 7 days

  3. serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes

    Measured: 7 days

  4. clinical relevant non-major bleedings

    Measured: 7 days

Secondary outcomes (4)
  1. the composite end point of death from any cause or treatment failure,recurrence of VTE

    Measured: 3 months and 6 months

  2. improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs

    Measured: 3 months and 6 months

  3. serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes

    Measured: 3 months and 6 months

  4. 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.

  1. First posted13 Feb 2012 (estimated)
  2. Study startJul 2009
  3. Primary completionJul 2012 (estimated)
  4. Study completionDec 2012 (estimated)

Resources

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)
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

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.

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