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China-Administration of Nicorandil Group（CHANGE）

NCT03445728 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 238

Last updated 2021-11-24

No results posted yet for this study

Summary

We compared the infarct size in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI) treated by nicorandil before and after the reperfusion with those standard therapy treated by PCI

Conditions

Interventions

DRUG

Nicorandil

After randomization, receive primary PCI and standard therapy, 12mg Nicorandil iv. just before ballooning or stenting, then keep Nicorandil 6mg/h ivgtt. up to 24h

OTHER

Placebo

After randomization, receive primary PCI and standard therapy, just like the intervension group also iv. just before ballooning or stenting, then keep ivgtt. up to 24h

Sponsors & Collaborators

  • First People's Hospital of Yulin

    collaborator OTHER

  • Beijing Chao Yang Hospital

    collaborator OTHER

  • Wuhan Asia Heart Hospital

    collaborator OTHER

  • Hainan Hospital of PLA General Hospital

    collaborator UNKNOWN

  • Zunyi Medical College

    collaborator OTHER

  • Guizhou Provincial People's Hospital

    collaborator OTHER

  • Second Affiliated Hospital of Nanchang University

    collaborator OTHER

  • The Second Hospital of Hebei Medical University

    collaborator OTHER

  • Chinese PLA General Hospital

    lead OTHER

Principal Investigators

  • Yundai Chen · Chinese PLA General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-02-24
Primary Completion
2020-07-31
Completion
2021-10-01

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03445728 on ClinicalTrials.gov