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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01531829
Other study ID # BJCYH1893
Secondary ID
Status Recruiting
Phase Phase 4
First received February 9, 2012
Last updated February 11, 2012
Start date July 2009
Est. completion date December 2012

Study information

Verified date February 2012
Source Beijing Chao Yang Hospital
Contact Chen Wang, PhD,MD
Phone 8610-85231893
Email cyh-birm@263.net
Is FDA regulated No
Health authority China: Ministry of Science and Technology
Study type Interventional

Clinical 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 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).


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.


Recruitment information / eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
Recombinant tissue plasminogen activator (rt-PA)
Low dose (50mg/2h) rt-PA plus LMWH
Low Molecular Weight Heparin
0.1ml/10kg,q12h,5-7 days

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Beijing Chao Yang Hospital Ministry of Science and Technology of the People´s Republic of China

Country where clinical trial is conducted

China, 

Outcome

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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