Back to resultsEffects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction (ERUPTION)
Primary Purpose
Myocardial Infarction, Percutaneous Coronary Intervention, Thrombolytic Therapy
Status
Completed
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Prourokinase
Tirofiban
normal saline
Sponsored by
About this trial
This is an interventional treatment trial for Myocardial Infarction focused on measuring No-Reflow Phenomenon
Eligibility 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
Sites / Locations
- Department of Cardiology, Zhongshan Hospital, Fudan University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Placebo Comparator
Arm Label
Prourokinase
Tirofiban
Normal saline
Arm Description
Intracoronary bolus infusion of 20mg prourokinase using selective catheter
Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg)
Intracoronary saline bolus infusion using selective catheter (20ml)
Outcomes
Primary Outcome Measures
Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)
Secondary Outcome Measures
ST segment resolution in ECG
peak troponin T level
plasma N terminal-proBNP levels
infarction area confirmed by SPECT
incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02131220
Brief Title
Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
Acronym
ERUPTION
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction, Percutaneous Coronary Intervention, Thrombolytic Therapy
Keywords
No-Reflow Phenomenon
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
362 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prourokinase
Arm Type
Experimental
Arm Description
Intracoronary bolus infusion of 20mg prourokinase using selective catheter
Arm Title
Tirofiban
Arm Type
Active Comparator
Arm Description
Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg)
Arm Title
Normal saline
Arm Type
Placebo Comparator
Arm Description
Intracoronary saline bolus infusion using selective catheter (20ml)
Intervention Type
Drug
Intervention Name(s)
Prourokinase
Other Intervention Name(s)
Reocmbinant Human Prourokinase for Injection, TIANJIN TASLY PHARMACEUTICAL CO.,LTD
Intervention Description
20mg intracoronary bolus infusion using selective catheter during PCI
Intervention Type
Drug
Intervention Name(s)
Tirofiban
Other Intervention Name(s)
Grand Pharmr (China) Co. Ltd
Intervention Description
10ug/kg intracoronary bolus infusion using selective catheter during PCI
Intervention Type
Drug
Intervention Name(s)
normal saline
Intervention Description
intracoronary bolus infusion using selective catheter during PCI
Primary Outcome Measure Information:
Title
Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)
Time Frame
At the end of Percutaneous Coronary Intervention procedure
Secondary Outcome Measure Information:
Title
ST segment resolution in ECG
Time Frame
3 hours post PCI procedure
Title
peak troponin T level
Time Frame
in the 7 days post PCI procedure
Title
plasma N terminal-proBNP levels
Time Frame
1 and 30 days post PCI procedure
Title
infarction area confirmed by SPECT
Time Frame
30 days post PCI
Title
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 Pre-specified Outcome Measures:
Title
TIMI defined total major bleeding
Time Frame
30 days post PCI
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Junbo Ge, M.D.
Organizational Affiliation
Department of Cardiology, Zhongshan Hospital, Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Cardiology, Zhongshan Hospital, Fudan University
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of Intracoronary Prourokinase on the Coronary Flow During Primary Percutaneous Coronary Intervention for Acute Myocardial Infarction
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