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Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction (ERUPTION)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Ge Junbo, Fudan University
Information provided by (Responsible Party):
Ge Junbo, Fudan University Identifier:
First received: May 3, 2014
Last updated: August 8, 2016
Last verified: August 2016
The purpose of this study is to determine whether intracoronary selective thrombolysis are more effective than tirofiban on the coronary flow during primary percutaneous coronary intervention for the acute myocardial infarction.

Condition Intervention Phase
Myocardial Infarction
Percutaneous Coronary Intervention
Thrombolytic Therapy
Drug: Prourokinase
Drug: Tirofiban
Drug: normal saline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Parallel-controlled, Multi-center Study of the Effects of Intracoronary Recombinant HUman Prourokinase or TIrofiban on the Coronary Flow During Primary PCI for the Acute Myocardial InfartiON

Resource links provided by NLM:

Further study details as provided by Ge Junbo, Fudan University:

Primary Outcome Measures:
  • Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC) [ Time Frame: At the end of Percutaneous Coronary Intervention procedure ]

Secondary Outcome Measures:
  • ST segment resolution in ECG [ Time Frame: 3 hours post PCI procedure ]
  • peak troponin T level [ Time Frame: in the 7 days post PCI procedure ]
  • plasma N terminal-proBNP levels [ Time Frame: 1 and 30 days post PCI procedure ]
  • infarction area confirmed by SPECT [ Time Frame: 30 days post PCI ]
  • incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization [ Time Frame: 30 days post PCI ]

Other Outcome Measures:
  • TIMI defined total major bleeding [ Time Frame: 30 days post PCI ]

Estimated Enrollment: 360
Study Start Date: November 2015
Estimated Study Completion Date: September 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prourokinase
Intracoronary bolus infusion of 20mg prourokinase using selective catheter
Drug: Prourokinase
20mg intracoronary bolus infusion using selective catheter during PCI
Other Names:
  • Reocmbinant Human Prourokinase for Injection
Active Comparator: Tirofiban
Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg)
Drug: Tirofiban
10ug/kg intracoronary bolus infusion using selective catheter during PCI
Other Name: Grand Pharmr (China) Co. Ltd
Placebo Comparator: Normal saline
Intracoronary saline bolus infusion using selective catheter (20ml)
Drug: normal saline
intracoronary bolus infusion using selective catheter during PCI


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

Inclusion Criteria:

  • ST-segment elevation AMI within 12 hours of symptom onset

Exclusion Criteria:

  • Contraindications to thrombolysis or PCI
  • Patients administered a fibrinolytic agent before PCI
  • Patients enrolled in clinical trials
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02131220

Contact: Dong Huang, M.D. 862113512142875

China, Shanghai
Department of Cardiology, Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Dong Huang, M.D.    862113512142875   
Sub-Investigator: Dong Huang, M.D.         
Sponsors and Collaborators
Fudan University
Principal Investigator: Junbo Ge, M.D. Department of Cardiology, Zhongshan Hospital, Fudan University
  More Information

Responsible Party: Ge Junbo, Director, Dept. of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University Identifier: NCT02131220     History of Changes
Other Study ID Numbers: Zhongshan 2012-134
Study First Received: May 3, 2014
Last Updated: August 8, 2016

Keywords provided by Ge Junbo, Fudan University:
No-Reflow Phenomenon

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors processed this record on May 25, 2017