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

Sponsor
Fudan University (Other)
Overall Status
Completed
CT.gov ID
NCT02131220
Collaborator
(none)
362
Enrollment
1
Location
3
Arms
22
Actual Duration (Months)
16.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
362 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 :
Nov 1, 2015
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Sep 1, 2017

Arms and Interventions

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 Names:
  • 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

    Outcome Measures

    Primary Outcome Measures

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

    Secondary Outcome Measures

    1. ST segment resolution in ECG [3 hours post PCI procedure]

    2. peak troponin T level [in the 7 days post PCI procedure]

    3. plasma N terminal-proBNP levels [1 and 30 days post PCI procedure]

    4. infarction area confirmed by SPECT [30 days post PCI]

    5. incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization [30 days post PCI]

    Other Outcome Measures

    1. TIMI defined total major bleeding [30 days post PCI]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    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

    Locations

    Site City State Country Postal Code
    1 Department of Cardiology, Zhongshan Hospital, Fudan University Shanghai Shanghai China 200032

    Sponsors and Collaborators

    • Fudan University

    Investigators

    • Principal Investigator: Junbo Ge, M.D., Department of Cardiology, Zhongshan Hospital, Fudan University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ge Junbo, Director, Dept. of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University
    ClinicalTrials.gov Identifier:
    NCT02131220
    Other Study ID Numbers:
    • Zhongshan 2012-134
    First Posted:
    May 6, 2014
    Last Update Posted:
    Aug 7, 2018
    Last Verified:
    Aug 1, 2018
    Keywords provided by Ge Junbo, Director, Dept. of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University
    No-Reflow Phenomenon
    Additional relevant MeSH terms:
    Myocardial Infarction
    Infarction
    Tirofiban
    Saruplase

    Study Results

    No Results Posted as of Aug 7, 2018