NCT00968929

Brief Summary

Recombinant streptokinase (r-SK) is an effective thrombolytic agent developed with gene engineering. Its characteristics of high output and low production cost make it affordable in treating acute myocardial infarction (AMI) in developing countries. It is unclear whether r-SK can be used in patients with pulmonary embolism (PE). The aim of this study was to investigate the efficacy and safety of 1.5 million IU r-SK by 2 hours infusion and 20,000 IU/kg urokinase (UK) by 2 hours infusion in selected PE patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
83

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2006

Typical duration for phase_4

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2009

Completed
Last Updated

September 1, 2009

Status Verified

August 1, 2009

Enrollment Period

2.9 years

First QC Date

August 28, 2009

Last Update Submit

August 31, 2009

Conditions

Pulmonary EmbolismPulmonary Thromboembolism

Keywords

pulmonary embolismthrombolysismassivesubmassiverecombinant streptokinaseurokinase

Outcome Measures

Primary Outcomes (3)

  • The improvement of the right ventricular function on echocardiogram

    within the 1st, 14 days and 3 months

  • Quantitative computed tomographic pulmonary angiography (CTPA) score

    1st, 14 days and 3 months

  • The relief of symptoms

    2-4h, 1st, 4th , 7th, 10th, 14 days day and 3 months

Secondary Outcomes (3)

  • Major or minor bleeding

    14 days and 3 months

  • Pulmonary embolism recurrence

    14 days and 3 months

  • Death

    14 days and 3 months

Study Arms (2)

r-SK group

EXPERIMENTAL

Recombinant streptokinase: 1.5 million IU continuously intravenous infusion for 2 hours

Drug: Recombinant Streptokinase

UK group

ACTIVE COMPARATOR

Urokinase: 20,000 IU/kg continuously intravenous infusion for 2 hours

Drug: Urokinase

Interventions

Recombinant StreptokinaseDRUG

Recombinant streptokinase: 1.5 million IU continuously intravenous infusion for 2 hours

r-SK group
UrokinaseDRUG

Urokinase: 20,000 IU/kg continuously intravenous infusion for 2 hours

UK group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptomatic PTE confirmed either by CTPA or by a high probability ventilation-perfusion lung scanning (V/Q scan).
  • Presented with hemodynamic instability (systolic blood pressure \<90 mmHg or a fall in systolic blood pressure of more than 40 mmHg for at least 15 min, or cardiogenic shock) or associated with RVD identified by echocardiography or CT.
  • Symptoms deterioration less than 14 days before diagnosis.

You may not qualify if:

  • Active bleeding or spontaneous intracranial hemorrhage in the preceding 6 months
  • Major surgery, organ biopsy or recent puncture of a non-compressible vessel in the preceding 2 weeks
  • Cerebral arterial thrombosis in the preceding 2 months
  • Gastro-intestinal bleeding in the preceding 10 days
  • Major trauma within the past 15 days
  • Neurosurgery or ophthalmologic operation in the preceding 1 month
  • Uncontrolled hypertension (systolic blood pressure \> 180 mmHg and/or diastolic blood pressure \> 110 mmHg)
  • Recent external cardiac resuscitation manoeuvres
  • Platelet count \< 100,000/mm3 at admission
  • Pregnancy, puerperium or lactation in the preceding 2 weeks
  • Infectious pericarditis or endocarditis
  • Severe hepatic and kidney dysfunction
  • Hemorrhagic retinopathy due to diabetes
  • A known bleeding disorder.
  • Chronic thromboembolic pulmonary hypertension (CTEPH) without new pulmonary thromboembolism (PTE)
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Beijing Institute of Respiratory Medicine, Beijing Chao-Yang hospital

Beijing, Beijing Municipality, 100020, China

Location

Guangdong Institute of Respiratory Disease, Guangzhou Medical University,

Guangzhou, Guangdong, 510120, China

Location

Shenzhen People's Hospital

Shenzhen, Guangdong, 518020, China

Location

The General Hospital of Shenyang Military Command

Shenyang, Liaoning, 110016, China

Location

Affiliated Hospital of Ningxia Medical University

Yinchuan, Ningxia, 750004, China

Location

The Affiliated Hospital of Medical College Qingdao University

Qingdao, Shandong, 266003, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, 030001, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China

Location

Related Publications (4)

  • Zhu L, Yang Y, Wu Y, Zhai Z, Wang C. Value of right ventricular dysfunction for prognosis in pulmonary embolism. Int J Cardiol. 2008 Jun 23;127(1):40-5. doi: 10.1016/j.ijcard.2007.06.093. Epub 2007 Aug 22.

    PMID: 17716753BACKGROUND

  • Zhu L, Yang YH, Wu YF, Zhai ZG, Wang C; National Project of the Diagnosis and Treatment Strategies for Pulmonary Thromboembolism investigators. Value of transthoracic echocardiography combined with cardiac troponin I in risk stratification in acute pulmonary thromboembolism. Chin Med J (Engl). 2007 Jan 5;120(1):17-21.

    PMID: 17254482BACKGROUND

  • Zhu L, Wang C, Yang Y, Wu Y, Zhai Z, Dai H, Pang B, Tong Z. Value of transthoracic echocardiography in therapy regimens evaluation in pulmonary embolism. J Thromb Thrombolysis. 2008 Dec;26(3):251-6. doi: 10.1007/s11239-007-0087-8. Epub 2007 Aug 21.

    PMID: 17705052BACKGROUND

  • Yang Wang, Chen Wang, Yuanhua Yang, Baosen Pang. Effect of recombinant single-chain urokinase-type plasminogen activator on experimental pulmonary embolism. Clin Appl Thromb Hemost. 2010 Oct;16(5):537-42. doi: 10.1177/1076029609343003. Epub 2009 Oct 14.

    PMID: 19833628BACKGROUND

MeSH Terms

Conditions

Pulmonary Embolism

Interventions

Urokinase-Type Plasminogen Activator

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesEmbolismEmbolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Serine EndopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesSerine ProteasesPlasminogen ActivatorsBlood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • Chen WANG, Prof

    Beijing Institute of Respiratory Medicine, Beijing-Chao Yang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 28, 2009

First Posted

August 31, 2009

Study Start

June 1, 2006

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

September 1, 2009

Record last verified: 2009-08

Locations

CN(8)