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

NCT ID: NCT02131220

Last Updated: 2018-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

362 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-30

Study Completion Date

2017-09-30

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.

Detailed Description

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Conditions

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Myocardial Infarction Percutaneous Coronary Intervention Thrombolytic Therapy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Prourokinase

Intracoronary bolus infusion of 20mg prourokinase using selective catheter

Group Type EXPERIMENTAL

Prourokinase

Intervention Type DRUG

20mg intracoronary bolus infusion using selective catheter during PCI

Tirofiban

Intracoronary tirofiban bolus infusion using selective catheter (10ug/kg)

Group Type ACTIVE_COMPARATOR

Tirofiban

Intervention Type DRUG

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

Normal saline

Intracoronary saline bolus infusion using selective catheter (20ml)

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

intracoronary bolus infusion using selective catheter during PCI

Interventions

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Prourokinase

20mg intracoronary bolus infusion using selective catheter during PCI

Intervention Type DRUG

Tirofiban

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

Intervention Type DRUG

normal saline

intracoronary bolus infusion using selective catheter during PCI

Intervention Type DRUG

Other Intervention Names

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Reocmbinant Human Prourokinase for Injection TIANJIN TASLY PHARMACEUTICAL CO.,LTD Grand Pharmr (China) Co. Ltd

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Ge Junbo

Director, Dept. of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Junbo Ge, M.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Cardiology, Zhongshan Hospital, Fudan University

Locations

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Department of Cardiology, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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Zhongshan 2012-134

Identifier Type: -

Identifier Source: org_study_id

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