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NCT02131220 Clinical Trial

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

Myocardial Infarction Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02131220
Other study ID # Zhongshan 2012-134
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2015
Est. completion date September 2017

Study information
Verified date August 2018
Source Fudan University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 362
Est. completion date September 2017
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Prourokinase
20mg intracoronary bolus infusion using selective catheter during PCI
• Tirofiban
10ug/kg intracoronary bolus infusion using selective catheter during PCI
• normal saline
intracoronary bolus infusion using selective catheter during PCI

Locations
Country Name City State
China Department of Cardiology, Zhongshan Hospital, Fudan University Shanghai Shanghai

Sponsors (1)
Lead Sponsor Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Other TIMI defined total major bleeding 30 days post PCI
Primary Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC) At the end of Percutaneous Coronary Intervention procedure
Secondary ST segment resolution in ECG 3 hours post PCI procedure
Secondary peak troponin T level in the 7 days post PCI procedure
Secondary plasma N terminal-proBNP levels 1 and 30 days post PCI procedure
Secondary infarction area confirmed by SPECT 30 days post PCI
Secondary incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization 30 days post PCI
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