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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Myocardial Infarction, Percutaneous Coronary Intervention, Thrombolytic Therapy

Intervention / Treatment
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* Drug: Prourokinase
* Drug: Tirofiban
* Drug: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prourokinase<br>Intracoronary bolus infusion of 20mg prourokinase using selective catheter | Drug: Prourokinase<br>* 20mg intracoronary bolus infusion using selective catheter during PCI<br>* Other names: TIANJIN TASLY PHARMACEUTICAL CO.,LTD;|
| Active Comparator: Tirofiban<br>Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg) | Drug: Tirofiban<br>* 10ug/kg intracoronary bolus infusion using selective catheter during PCI<br>* Other names: Grand Pharmr (China) Co. Ltd;|
| Placebo Comparator: Normal saline<br>Intracoronary saline bolus infusion using selective catheter (20ml) | Drug: normal saline<br>* intracoronary bolus infusion using selective catheter during PCI<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| infarction area confirmed by SPECT |  | 30 days post PCI | 
| incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization |  | 30 days post PCI | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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No-Reflow Phenomenon