China-Administration of Nicorandil Group（CHANGE）

Chinese PLA General Hospital (301 Hospital)

Status and phase: Completed; Phase 4

Conditions: Percutaneous Coronary Intervention; Nicorandil; Myocardial Infarction

Treatments: Other: Placebo; Drug: Nicorandil

Study type: Interventional

Funder types: Other

Identifiers

NCT03445728

CHANGE 001

Details and patient eligibility

About

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

Full 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, randomized, double-blind and parallel-controlled clinical study, providing evidence-based support for the optimization of PCI treatment strategies. The primary objective of the study was to compare whether the effect of nicorandil in combination with PCI was significantly better at reducing the myocardial infarct size than that of PCI alone in AMI patients.

Enrollment: 238 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Acute ST-T elevation MI patients (<12h)
2. undergoing emergency PCI；
3. Subject has read and signed a written, informed consent form.

Exclusion criteria

1. SBP<80mmHg；
2. LM stenosis
3. Aortic dissection；
4. AMI (<6 month)
5. PCI或CABG (<6 month)
6. Already under the treatment of Nicorandil；
7. Contraindicated or intolerable to Nicorandil
8. severe adverse effects to CMR or MRI；
9. Currently (or within one month) participating in another new drug trial.；
10. Pregnant or lactation period；
11. 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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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238 participants in 2 patient groups, including a placebo group

Treatment arm

Experimental group

Description:

Patients were randomly assigned to two groups before emergent coronary angiography: those who received intravenous (iv.) nicorandil before and after (ivgtt.) reperfusion with PCI (nicorandil group);

Treatment:

Drug: Nicorandil

Placebo arm

Placebo Comparator group

Description:

Patients were randomly assigned to two groups before emergent coronary angiography, those who received placebo before and after reperfusion with PCI.

Treatment:

Other: Placebo