ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02131220
Recruitment Status : Recruiting
First Posted : May 6, 2014
Last Update Posted : August 1, 2017
Sponsor:
Information provided by (Responsible Party):
Ge Junbo, Fudan University

Brief Summary:
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 or disease Intervention/treatment Phase
Myocardial Infarction Percutaneous Coronary Intervention Thrombolytic Therapy Drug: Prourokinase Drug: Tirofiban Drug: normal saline Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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
Actual Study Start Date : November 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
U.S. FDA Resources

Arm Intervention/treatment
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
  • TIANJIN TASLY PHARMACEUTICAL CO.,LTD
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



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

Secondary Outcome Measures :
  1. ST segment resolution in ECG [ Time Frame: 3 hours post PCI procedure ]
  2. peak troponin T level [ Time Frame: in the 7 days post PCI procedure ]
  3. plasma N terminal-proBNP levels [ Time Frame: 1 and 30 days post PCI procedure ]
  4. infarction area confirmed by SPECT [ Time Frame: 30 days post PCI ]
  5. 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:
  1. TIMI defined total major bleeding [ Time Frame: 30 days post PCI ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

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

Information from the National Library of Medicine

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): NCT02131220


Contacts
Contact: Dong Huang, M.D. 862113512142875 huang.dong@zs-hospital.sh.cn

Locations
China, Shanghai
Department of Cardiology, Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200032
Contact: Dong Huang, M.D.    862113512142875    huang.dong@zs-hospital.sh.cn   
Sub-Investigator: Dong Huang, M.D.         
Sponsors and Collaborators
Fudan University
Investigators
Principal Investigator: Junbo Ge, M.D. Department of Cardiology, Zhongshan Hospital, Fudan University

Responsible Party: Ge Junbo, Director, Dept. of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University
ClinicalTrials.gov Identifier: NCT02131220     History of Changes
Other Study ID Numbers: Zhongshan 2012-134
First Posted: May 6, 2014    Key Record Dates
Last Update Posted: August 1, 2017
Last Verified: July 2017

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

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Tirofiban
Saruplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors