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

Phase 4

Completed

• Conditions: Myocardial Infarction; Percutaneous Coronary Intervention; Thrombolytic Therapy
• Interventions: Drug: normal saline; Drug: Prourokinase; Drug: Tirofiban

• Registration Number: NCT02131220
• Lead Sponsor: Fudan University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-05-03
• Study First Submitted QC: 2014-05-03
• Study First Posted: 2014-05-06
• Study Start: 2015-11
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-04
• Last Update Posted: 2018-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	normal saline	Intracoronary saline bolus infusion using selective catheter (20ml)
Prourokinase	Prourokinase	Intracoronary bolus infusion of 20mg prourokinase using selective catheter
Tirofiban	Tirofiban	Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization	30 days post PCI
infarction area confirmed by SPECT	30 days post PCI
ST segment resolution in ECG	3 hours post PCI procedure
peak troponin T level	in the 7 days post PCI procedure
plasma N terminal-proBNP levels	1 and 30 days post PCI procedure

Trial Locations

Locations (1)

Department of Cardiology, Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China