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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2015 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Ge Junbo, Fudan University
ClinicalTrials.gov Identifier:
NCT02131220
First received: May 3, 2014
Last updated: April 3, 2015
Last verified: April 2015
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ST segment resolution in ECG [ Time Frame: 3 hours post PCI procedure ] [ Designated as safety issue: No ]
  • peak troponin T level [ Time Frame: in the 7 days post PCI procedure ] [ Designated as safety issue: No ]
  • plasma N terminal-proBNP levels [ Time Frame: 1 and 30 days post PCI procedure ] [ Designated as safety issue: No ]
  • infarction area confirmed by SPECT [ Time Frame: 30 days post PCI ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • TIMI defined total major bleeding [ Time Frame: 30 days post PCI ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 360
Study Start Date: May 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
  • 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  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 ClinicalTrials.gov identifier: NCT02131220

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

Locations
China, Shanghai
Department of Cardiology, Zhongshan Hospital, Fudan University Not yet 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
  More Information

No publications provided

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
Study First Received: May 3, 2014
Last Updated: April 3, 2015
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
No-Reflow Phenomenon

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

ClinicalTrials.gov processed this record on May 21, 2015