Status:
COMPLETED
China-Administration of Nicorandil Group（CHANGE）
Lead Sponsor:
Chinese PLA General Hospital
Collaborating Sponsors:
First People's Hospital of Yulin
Beijing Chao Yang Hospital
Conditions:
Myocardial Infarction
Percutaneous Coronary Intervention
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief 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 reper...
Detailed Description
The aim of this study was to evaluate the efficacy and safety of nicorandil in improving myocardial infarct size in patients with acute myocardial infarction through a multi-center, prospective, rando...
Eligibility Criteria
Inclusion
- Acute ST-T elevation MI patients (\<12h)
- undergoing emergency PCI；
- Subject has read and signed a written, informed consent form.
Exclusion
- SBP\<80mmHg；
- LM stenosis
- Aortic dissection；
- AMI (\<6 month)
- PCI或CABG (\<6 month)
- Already under the treatment of Nicorandil；
- Contraindicated or intolerable to Nicorandil
- severe adverse effects to CMR or MRI；
- Currently (or within one month) participating in another new drug trial.；
- Pregnant or lactation period；
- Severe somatic disease preventing the participant from completing the trial, or based on the discretion of the investigators, the patient is incapable of participating; Individuals with abnormal laboratory test results and/or clinical manifestations rendering them unsuitable to participate as judged by the investigators;
Key Trial Info
Start Date :
February 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2021
Estimated Enrollment :
238 Patients enrolled
Trial Details
Trial ID
NCT03445728
Start Date
February 24 2018
End Date
October 1 2021
Last Update
November 24 2021
Active Locations (1)
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1
CHINA
Beijing, China