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

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ClinicalTrials.gov Identifier: NCT01531829
Recruitment Status : Unknown
Verified February 2012 by Chen WANG, Beijing Chao Yang Hospital.
Recruitment status was:  Recruiting
First Posted : February 13, 2012
Last Update Posted : February 14, 2012
Sponsor:
Collaborator:
Ministry of Science and Technology of the People´s Republic of China
Information provided by (Responsible Party):
Chen WANG, Beijing Chao Yang Hospital

Study Description
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Brief 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 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).

Condition or disease Intervention/treatment Phase
Pulmonary Thromboembolisms Pulmonary Embolism Drug: Recombinant tissue plasminogen activator (rt-PA) Drug: Low Molecular Weight Heparin Phase 4

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 460 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : July 2009
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : December 2012

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Arms and Interventions
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Arm Intervention/treatment
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 Name: rt-PA
Active Comparator: LMWH
Low molecular weight heparin
 Drug: Low Molecular Weight Heparin
0.1ml/10kg,q12h,5-7 days
Other Name: Nadroparin


Outcome Measures
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Primary Outcome Measures :
  1. the composite end point of death from any cause or treatment failure,recurrence of VTE [ Time Frame: 7 days ]
  2. improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs [ Time Frame: 7 days ]
  3. serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes [ Time Frame: 7 days ]
  4. clinical relevant non-major bleedings [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. the composite end point of death from any cause or treatment failure,recurrence of VTE [ Time Frame: 3 months and 6 months ]
  2. improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs [ Time Frame: 3 months and 6 months ]
  3. serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes [ Time Frame: 3 months and 6 months ]
  4. clinical relevant non-major bleedings [ Time Frame: 3 months and 6 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531829


Contacts
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Contact: Chen Wang, PhD,MD 8610-85231893 cyh-birm@263.net
Contact: Tuguang Kuang, PhD,MD 8610-85231451 ktg2004@sina.com

Locations
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Sponsors and Collaborators
Beijing Chao Yang Hospital
Ministry of Science and Technology of the People´s Republic of China
Investigators
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Principal Investigator: Chen Wang, PhD,MD Beijing Chao Yang Hospital
More Information
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Responsible Party: Chen WANG, Professor of respiratory and critical care medicine, Beijing Chao Yang Hospital
ClinicalTrials.gov Identifier: NCT01531829    
Other Study ID Numbers: BJCYH1893
First Posted: February 13, 2012    Key Record Dates
Last Update Posted: February 14, 2012
Last Verified: February 2012
Keywords provided by Chen WANG, Beijing Chao Yang Hospital:
pulmonary embolism
right ventricular dysfunction
Thrombolysis
Heparin
Additional relevant MeSH terms:
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Pulmonary Embolism
Thromboembolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Heparin
Plasminogen
 Heparin, Low-Molecular-Weight
Tinzaparin
Dalteparin
Tissue Plasminogen Activator
Nadroparin
Anticoagulants
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action