Low Dose Rt-PA for Acute Normotensive Pulmonary Embolism With RVD

February 11, 2012 updated by: Chen WANG, Beijing Chao Yang Hospital

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Tuguang Kuang, PhD,MD
  • Phone Number: 8610-85231451
  • Email: ktg2004@sina.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Daxing People's Hospital
        • Contact:
          • Yongxiang Zhang, MD
        • Principal Investigator:
          • Yongxiang Zhang, MD
      • Beijing, Beijing, China
        • Recruiting
        • Beijing Fuwai hospital
        • Contact:
          • Zhihong Liu, MD
        • Principal Investigator:
          • Zhihong Liu, MD
      • Beijing, Beijing, China
        • Not yet recruiting
        • Beijing Hospital, Ministry of Health
        • Contact:
          • Baomin Fang, MD
        • Principal Investigator:
          • Baoming Fang, MD
      • Bejing, Beijing, China, 100020
        • Recruiting
        • Beijing Chao Yang Hospial
        • Contact:
        • Principal Investigator:
          • Chen Wang, PhD,MD
        • Sub-Investigator:
          • Yuanhua Yang, PhD,MD
    • GUang Dong
      • Guang Zhou, GUang Dong, China
        • Recruiting
        • The Third Affiliated Hospital of Zhongshan University in Guangzhou
        • Contact:
          • yulin Zhou, MD
        • Principal Investigator:
          • Tiantuo Zhang, MD
    • Guangdong
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital of Zhongshan University in Guangzhou
        • Contact:
          • Mian Zeng, MD
        • Principal Investigator:
          • Canmao Xie, MD
    • Guangxi
      • Nan ning, Guangxi, China
        • Recruiting
        • The Guangxi Zhuang Autonomous Region people's Hospital
        • Contact:
          • shengze Long, MD
        • Principal Investigator:
          • Zhiqiang Qing, PhD,MD
    • Guangzhou
      • Shenzhen, Guangzhou, China
        • Recruiting
        • Guangzhou Shenzhen People's Hospital
        • Contact:
          • Chen Qiu, MD
        • Principal Investigator:
          • Chen Qiu, MD
    • Hebei
      • Chengde, Hebei, China
        • Recruiting
        • Affiliated Hospital of Chengde Medical College
        • Principal Investigator:
          • Qing Zhang, MD
        • Contact:
          • Guifang Pang, MD
      • Handan, Hebei, China
        • Recruiting
        • The first hospital of Handan city Hebei Province
        • Contact:
          • Jinghui Ye, MD
        • Principal Investigator:
          • Jinghui Ye, MD
      • Hengshui, Hebei, China
        • Recruiting
        • Hebei Hengshui international Heping Hospital
        • Contact:
          • Zhaobo Cui, MD
        • Principal Investigator:
          • Zhaobo Cui, MD
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei Affiliated Hospital of North China Coal Medical University
        • Contact:
          • Baibing Liu, MD
        • Principal Investigator:
          • Hongyang Wang, MD
      • Shijiazhuang, Hebei, China
        • Recruiting
        • Hebei Medical University Second Hospital
        • Contact:
          • Yadong Yuan, MD
        • Principal Investigator:
          • Yadong Yuan, MD
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • Recruiting
        • No.2 Affiliated Hospital of Harbin Medical University
        • Contact:
          • Hong Chen, MD
        • Principal Investigator:
          • Hong Chen, MD
    • Inner Mongolia
      • Baotou, Inner Mongolia, China
        • Recruiting
        • The Third Affiliated Hospital of Inner Mongolia Medical College
        • Contact:
          • Ling Wang, MD
        • Principal Investigator:
          • Jingping Yang, MD
      • Hohhot, Inner Mongolia, China
        • Recruiting
        • Hospital of Inner Mongolia Autonomous Region
        • Contact:
          • Weilie Wang, MD
        • Principal Investigator:
          • Wenting Zhang, MD
    • Liaoning
      • Anshan, Liaoning, China
        • Recruiting
        • Anshan Iron and Steel Company General Hospital
        • Contact:
          • Hongyu Zhou, MD
        • Principal Investigator:
          • Hongyu Zhou, MD
      • Dalian, Liaoning, China
        • Recruiting
        • The First Hospital of Dalian Medical University
        • Contact:
          • Yingqun Ji, MD
        • Principal Investigator:
          • Zhonghe Zhang, MD
      • Shenyang, Liaoning, China
        • Recruiting
        • Liaoning General Hospital of Shenyang Military Region
        • Contact:
          • Liang Shi, MD
        • Principal Investigator:
          • Zhuang Ma, MD
      • Shenyang, Liaoning, China
        • Recruiting
        • Shenyang Medical College affiliated Fengtian Hospital
        • Contact:
          • Shuyue Xia, MD
        • Principal Investigator:
          • Shuyue Xia, MD
    • Ningxia
      • Yinchuan, Ningxia, China
        • Recruiting
        • Affiliated Hospital of Ningxia Medical University
        • Contact:
          • Zheng Yang, MD
        • Principal Investigator:
          • Jin Zhang, MD
    • Shandong
      • Jining, Shandong, China
        • Recruiting
        • Shandong Jining Medical University Affiliated Hospital
        • Contact:
          • Luning Jiang, MD
        • Principal Investigator:
          • Luning Jiang, MD
      • Qingdao, Shandong, China
        • Recruiting
        • Shandong Medical College Affiliated Hospital of Qiingdao University
        • Contact:
          • Li Tong, MD
        • Principal Investigator:
          • Zhaozhong Cheng, MD
      • Yantai, Shandong, China
        • Recruiting
        • Shandong Yantai city Yantai Mountain hospital
        • Contact:
          • Lijun Kang, MD
        • Principal Investigator:
          • Shudong Zhang, MD
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Ruijin Hospital Affiliated to Shanghai Jiao Tong University
        • Contact:
          • Guochao Shi, MD
        • Principal Investigator:
          • Shaoguang Huang, MD
      • Shanghai, Shanghai, China
        • Recruiting
        • Second Military Medical University Changhai Hospital
        • Contact:
          • Wei Zhang, MD
        • Principal Investigator:
          • Qiang Li, MD
      • Shanghai, Shanghai, China
        • Recruiting
        • Zhongshan Hospital Affiliated to Shanghai Fudan University
        • Contact:
          • Jinjun Jiang, MD
        • Principal Investigator:
          • Chunxue Bai, PhD,MD
    • Shanxi
      • Taiyuan, Shanxi, China
        • Recruiting
        • Shanxi Medical University Second Hospital
        • Contact:
          • Xu Wang, MD
        • Principal Investigator:
          • Zhuola Liu, MD
      • Taiyuan, Shanxi, China
        • Recruiting
        • The First Hospital of Shanxi Medical University
        • Contact:
          • Xiaoyun Hu, MD
        • Principal Investigator:
          • Yongcheng Du, MD
      • Xi'an, Shanxi, China
        • Recruiting
        • The Fourth Military Medical University, Xijing Hospital
        • Contact:
          • Shengqing Li, PhD, MD
        • Principal Investigator:
          • Changgui Wu, MD
    • Sichuan
      • Chengdu, Sichuan, China
        • Recruiting
        • Sichuan University, West China Hospital
        • Contact:
          • Qun Yi, MD
        • Principal Investigator:
          • Qun Yi, MD
    • Xinjiang
      • Urumqi, Xinjiang, China
        • Recruiting
        • The First Hospital of Xinjiang Medical University
        • Contact:
          • Zaiyi Wang, MD
        • Principal Investigator:
          • Zaiyi Wang, MD
      • Urumqi, Xinjiang, China
        • Recruiting
        • The Xinjiang Uygur Autonomous Region people's Hospital
        • Contact:
          • Ying Chen, MD
        • Principal Investigator:
          • Xiaohong Yang, MD
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Recruiting
        • Zhejiang Sir Run Run Shaw Hospital
        • Contact:
          • Guofeng Ma, MD
        • Principal Investigator:
          • Kejing Ying, MD
      • Wenzhou, Zhejiang, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical College in Zhejiang
        • Contact:
          • Yupeng Xie, MD
        • Principal Investigator:
          • Liangxing Wang, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 y≤Age≤75y
  2. 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
  3. Hemodynamic stability, diastolic pressure>90mmHg.

  4. 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

Exclusion Criteria:

  1. RV anterior wall thickness > 5mm confirmed by echocardiography
  2. Active internal bleeding and spontaneous intracranial hemorrhage in preceding 6 months
  3. Major surgery, organ biopsy or non-compressible punctures within 2 weeks
  4. Ischemic stroke occurred within 2 months
  5. Gastrointestinal bleeding within 10 days
  6. Severe trauma occurred within15 days
  7. Neurosurgery or eye surgery within 1 months
  8. Severe hypertension difficult to control (systolic blood pressure>180mmHg or diastolic blood pressure>110mmHg)
  9. Cardiopulmonary resuscitation
  10. Platelet count less than 100×109 / L
  11. Pregnancy, or within 2 week post partum
  12. Infective endocarditis; left atrial thrombus; aneurysm
  13. Serious liver and kidney dysfunction
  14. Diabetic hemorrhagic retinopathy
  15. Suffering with bleeding disorders
  16. Chronic thromboembolic pulmonary hypertension
  17. Moderate to severe chronic obstructive pulmonary disease (COPD).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Low dose (50mg/2h) rt-PA plus LMWH
Low dose (50mg/2h) recombinant tissue plasminogen activator (rt-PA) plus low molecular weight heparin(LMWH)regimen
Drug: Recombinant tissue plasminogen activator (rt-PA)
Low dose (50mg/2h) rt-PA plus LMWH
Other Names:
  • rt-PA
Active Comparator: LMWH
Low molecular weight heparin
Drug: Low Molecular Weight Heparin
0.1ml/10kg,q12h,5-7 days
Other Names:
  • Nadroparin

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
the composite end point of death from any cause or treatment failure,recurrence of VTE
Time Frame: 7 days
7 days
improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs
Time Frame: 7 days
7 days
serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes
Time Frame: 7 days
7 days
clinical relevant non-major bleedings
Time Frame: 7 days
7 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
the composite end point of death from any cause or treatment failure,recurrence of VTE
Time Frame: 3 months and 6 months
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
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
3 months and 6 months
clinical relevant non-major bleedings
Time Frame: 3 months and 6 months
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Chao Yang Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ministry of Science and Technology of the People´s Republic of China

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chen Wang, PhD,MD, Beijing Chao Yang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 9, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 13, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 14, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BJCYH1893

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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