Pulmonary Embolism Clinical Trial
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).
Status | Recruiting |
Enrollment | 460 |
Est. completion date | December 2012 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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). |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
China | Anshan Iron and Steel Company General Hospital | Anshan | Liaoning |
China | The Third Affiliated Hospital of Inner Mongolia Medical College | Baotou | Inner Mongolia |
China | Beijing Daxing People's Hospital | Beijing | Beijing |
China | Beijing Fuwai Hospital | Beijing | Beijing |
China | Beijing Hospital, Ministry of Health | Beijing | Beijing |
China | Beijing Chao Yang Hospial | Bejing | Beijing |
China | Affiliated Hospital of Chengde Medical College | Chengde | Hebei |
China | Sichuan University, West China Hospital | Chengdu | Sichuan |
China | The first hospital of Dalian Medical University | Dalian | Liaoning |
China | The Third Affiliated Hospital of Zhongshan University in Guangzhou | Guang Zhou | GUang Dong |
China | The First Affiliated Hospital of Zhongshan University in Guangzhou | Guangzhou | Guangdong |
China | The first hospital of Handan city Hebei Province | Handan | Hebei |
China | Zhejiang Sir Run Run Shaw Hospital | Hangzhou | Zhejiang |
China | No.2 Affiliated Hospital of Harbin Medical University | Harbin | Heilongjiang |
China | Hebei Hengshui international Heping Hospital | Hengshui | Hebei |
China | Hospital of Inner Mongolia Autonomous Region | Hohhot | Inner Mongolia |
China | Shandong Jining Medical University Affiliated Hospital | Jining | Shandong |
China | The Guangxi Zhuang Autonomous Region people's Hospital | Nan ning | Guangxi |
China | Shandong Medical College Affiliated Hospital of Qiingdao University | Qingdao | Shandong |
China | Ruijin Hospital Affiliated to Shanghai Jiao Tong University | Shanghai | Shanghai |
China | Second Military Medical University Changhai Hospital | Shanghai | Shanghai |
China | Zhongshan Hospital Affiliated to Shanghai Fudan University | Shanghai | Shanghai |
China | Liaoning General Hospital of Shenyang Military Region | Shenyang | Liaoning |
China | Shenyang Medical College affiliated Fengtian Hospital | Shenyang | Liaoning |
China | Guangzhou Shenzhen People's Hospital | Shenzhen | Guangzhou |
China | Hebei Affiliated Hospital of North China Coal Medical University | Shijiazhuang | Hebei |
China | Hebei Medical University Second Hospital | Shijiazhuang | Hebei |
China | Shanxi Medical University Second Hospital | Taiyuan | Shanxi |
China | The first hospital of Shanxi Medical University | Taiyuan | Shanxi |
China | The first hospital of Xinjiang Medical University | Urumqi | Xinjiang |
China | The Xinjiang Uygur Autonomous Region people's Hospital | Urumqi | Xinjiang |
China | The First Affiliated Hospital of Wenzhou Medical College in Zhejiang | Wenzhou | Zhejiang |
China | The Fourth Military Medical University, Xijing Hospital | Xi'an | Shanxi |
China | Shandong Yantai city Yantai Mountain hospital | Yantai | Shandong |
China | Affiliated Hospital of Ningxia Medical University | Yinchuan | Ningxia |
Lead Sponsor | Collaborator |
---|---|
Beijing Chao Yang Hospital | Ministry of Science and Technology of the People´s Republic of China |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | the composite end point of death from any cause or treatment failure,recurrence of VTE | 7 days | No | |
Primary | improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs | 7 days | No | |
Primary | serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes | 7 days | Yes | |
Primary | clinical relevant non-major bleedings | 7 days | Yes | |
Secondary | the composite end point of death from any cause or treatment failure,recurrence of VTE | 3 months and 6 months | No | |
Secondary | improvements of right ventricular functions on echocardiogram and pulmonary artery obstruction on CT angiographs | 3 months and 6 months | No | |
Secondary | serious life threatening bleeding such as cerebral hemorrhage and other major bleeding episodes | 3 months and 6 months | Yes | |
Secondary | clinical relevant non-major bleedings | 3 months and 6 months | Yes |
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