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

August 4, 2018 updated by: Ge Junbo, Fudan University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

362

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200032
        • Department of Cardiology, Zhongshan Hospital, Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)
Time Frame: At the end of Percutaneous Coronary Intervention procedure
At the end of Percutaneous Coronary Intervention procedure

Secondary Outcome Measures

Outcome Measure
Time Frame
ST segment resolution in ECG
Time Frame: 3 hours post PCI procedure
3 hours post PCI procedure
peak troponin T level
Time Frame: in the 7 days post PCI procedure
in the 7 days post PCI procedure
plasma N terminal-proBNP levels
Time Frame: 1 and 30 days post PCI procedure
1 and 30 days post PCI procedure
infarction area confirmed by SPECT
Time Frame: 30 days post PCI
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
30 days post PCI

Other Outcome Measures

Outcome Measure
Time Frame
TIMI defined total major bleeding
Time Frame: 30 days post PCI
30 days post PCI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fudan University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

May 3, 2014

First Submitted That Met QC Criteria

May 3, 2014

First Posted (Estimate)

May 6, 2014

Study Record Updates

Last Update Posted (Actual)

August 7, 2018

Last Update Submitted That Met QC Criteria

August 4, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhongshan 2012-134

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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