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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02131220
Acronym
ERUPTION
Enrollment
362
Registered
2014-05-06
Start date
2015-11-30
Completion date
2017-09-30
Last updated
2018-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myocardial Infarction, Percutaneous Coronary Intervention, Thrombolytic Therapy

Keywords

No-Reflow Phenomenon

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.

Interventions

DRUGnormal saline

intracoronary bolus infusion using selective catheter during PCI

20mg intracoronary bolus infusion using selective catheter during PCI

DRUGTirofiban

10ug/kg intracoronary bolus infusion using selective catheter during PCI

Sponsors

Fudan University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
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

Design outcomes

Primary

MeasureTime frame
Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)At the end of Percutaneous Coronary Intervention procedure

Secondary

MeasureTime frame
ST segment resolution in ECG3 hours post PCI procedure
peak troponin T levelin the 7 days post PCI procedure
infarction area confirmed by SPECT30 days post PCI
incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization30 days post PCI
plasma N terminal-proBNP levels1 and 30 days post PCI procedure

Other

MeasureTime frame
TIMI defined total major bleeding30 days post PCI

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026