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OpenTrials
Completed

NCT Number: NCT02131220

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

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.

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Key information

Conditions

Myocardial Infarction Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Ischemia Necrosis No-Reflow Phenomenon Pathologic Processes Pathological Conditions, Signs and Symptoms Percutaneous Coronary Intervention Thrombolytic Therapy Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Department of Cardiology, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prourokinase

Drug

20mg intracoronary bolus infusion using selective catheter during PCI

Other names: Reocmbinant Human Prourokinase for Injection, TIANJIN TASLY PHARMACEUTICAL CO.,LTD

tirofiban

Drug

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

Other names: Grand Pharmr (China) Co. Ltd

normal saline

Drug

intracoronary bolus infusion using selective catheter during PCI

Primary outcomes

  1. Coronary flow using corrected Thrombolysis In Myocardial Infarction Frame Count (cTFC)

    Time frame: At the end of Percutaneous Coronary Intervention procedure

Secondary outcomes

  1. ST segment resolution in ECG

    Time frame: 3 hours post PCI procedure

  2. peak troponin T level

    Time frame: in the 7 days post PCI procedure

  3. plasma N terminal-proBNP levels

    Time frame: 1 and 30 days post PCI procedure

  4. infarction area confirmed by SPECT

    Time frame: 30 days post PCI

  5. incidence of major adverse cardiac events (MACE) defined as the composite of death, myocardial infarction and target vessel revascularization

    Time frame: 30 days post PCI

Other outcomes

  1. TIMI defined total major bleeding

    Time frame: 30 days post PCI

Sponsors and collaborators

Lead sponsor

Fudan University

Other

Registry information

Official study 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

Acronym: ERUPTION

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
May 6, 2014
Registry last updated
Aug 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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