NCT02131220

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
362

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Nov 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2014

Completed
1.5 years until next milestone

Study Start

First participant enrolled

November 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

May 3, 2014

Last Update Submit

August 4, 2018

Conditions

Myocardial InfarctionPercutaneous Coronary InterventionThrombolytic Therapy

Keywords

No-Reflow Phenomenon

Outcome Measures

Primary Outcomes (1)

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

    At the end of Percutaneous Coronary Intervention procedure

Secondary Outcomes (5)

  • 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

Other Outcomes (1)

  • TIMI defined total major bleeding

    30 days post PCI

Study Arms (3)

Prourokinase

EXPERIMENTAL

Intracoronary bolus infusion of 20mg prourokinase using selective catheter

Drug: Prourokinase

Tirofiban

ACTIVE COMPARATOR

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

Drug: Tirofiban

Normal saline

PLACEBO COMPARATOR

Intracoronary saline bolus infusion using selective catheter (20ml)

Drug: normal saline

Interventions

ProurokinaseDRUG

20mg intracoronary bolus infusion using selective catheter during PCI

Also known as: Reocmbinant Human Prourokinase for Injection, TIANJIN TASLY PHARMACEUTICAL CO.,LTD
Prourokinase
TirofibanDRUG

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

Also known as: Grand Pharmr (China) Co. Ltd
Tirofiban
normal salineDRUG

intracoronary bolus infusion using selective catheter during PCI

Normal saline

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ST-segment elevation AMI within 12 hours of symptom onset

You may not qualify if:

  • Contraindications to thrombolysis or PCI
  • Patients administered a fibrinolytic agent before PCI
  • Patients enrolled in clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Cardiology, Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Myocardial InfarctionNo-Reflow Phenomenon

Interventions

saruplaseInjectionsTirofibanSaline Solution

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Drug Administration RoutesDrug TherapyTherapeuticsTyrosineAmino Acids, AromaticAmino Acids, CyclicAmino AcidsAmino Acids, Peptides, and ProteinsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Junbo Ge, M.D.

    Department of Cardiology, Zhongshan Hospital, Fudan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Dept. of Cardiology, Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital

Study Record Dates

First Submitted

May 3, 2014

First Posted

May 6, 2014

Study Start

November 1, 2015

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

August 7, 2018

Record last verified: 2018-08

Locations

CN(1)