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Published on: May 28, 2019
Intravenous Nicorandil in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI: The CLEAN
Dong Huang1, Hongxian Wu1, Yuan Lu2
1Department of Cardiology, Zhongshan Hospital, Fudan University, Shanghai Institute of Cardiovascular Diseases, Shanghai, China.
Insights
Adjunctive intravenous nicorandil did not significantly improve 12-month outcomes for ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention. The study found no significant difference in the primary composite outcome between nicorandil and placebo groups.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- Nicorandil, a potassium-channel opener with nitrate properties, is investigated for reducing reperfusion injury in ST-segment elevation myocardial infarction (STEMI).
- Previous evidence on long-term outcomes of nicorandil in STEMI is limited and inconclusive.
- The CLEAN trial addresses the need for large-scale randomized data on nicorandil's efficacy.
Purpose of the Study:
- To evaluate the effectiveness of adjunctive intravenous nicorandil in improving 12-month clinical outcomes.
- To assess the impact of nicorandil on major adverse cardiovascular events in STEMI patients.
- To provide robust evidence for the use of nicorandil in primary percutaneous coronary intervention settings.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial involving 1,503 STEMI patients.
- Patients received either intravenous nicorandil or placebo for 48 hours post-primary percutaneous coronary intervention.
- The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, target vessel revascularization, or heart failure hospitalization within 12 months.
Main Results:
- The primary composite outcome occurred in 13.1% of the nicorandil group and 13.1% of the placebo group (rate ratio: 0.869; P = 0.3429).
- No significant difference was observed in the primary outcome between the nicorandil and placebo arms.
- Nominal reductions in cardiovascular death and target-vessel revascularization were noted in the nicorandil group, but other secondary outcomes and adverse events were similar.
Conclusions:
- Adjunctive intravenous nicorandil did not significantly reduce the 12-month primary composite outcome in STEMI patients undergoing primary percutaneous coronary intervention.
- The findings do not support the routine use of intravenous nicorandil in unselected STEMI patients.
- Further research may be needed to identify specific patient subgroups who might benefit from nicorandil therapy.
Background:
Nicorandil, an adenosine triphosphate-sensitive potassium-channel opener with nitrate-like properties, may reduce reperfusion injury and microvascular obstruction in ST-segment elevation myocardial infarction (STEMI), but large-scale randomized evidence on long-term clinical outcomes is inconclusive.
Objectives:
The CLEAN trial aimed to assess whether adjunctive intravenous nicorandil improves 12-month clinical outcomes in patients with STEMI undergoing primary percutaneous coronary intervention.
Methods:
In this multicenter, randomized, double-blind, placebo-controlled trial conducted at 49 hospitals in China, patients aged 18 to 80 years with STEMI within 12 hours of symptom onset were randomly assigned (1:1) to receive intravenous nicorandil (6 mg bolus before reperfusion followed by 6 mg/h infusion for 48 h) or matching placebo. Oral nicorandil was prohibited during follow-up. The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, target vessel revascularization, or unplanned hospitalization for heart failure within 12 months.
Results:
Between January 2021 and December 2023, 1,503 patients were enrolled and randomly assigned to nicorandil (n = 748) or placebo (n = 755). The primary composite outcome occurred in 98 patients (13.1%) in the nicorandil group (113 events over 717.2 person-years) and 99 (13.1%) in the placebo group (136 events over 710.3 person-years), with no significant difference between groups (rate ratio: 0.869; 95% CI: 0.650-1.162; P = 0.3429). Among secondary outcomes, nominal reductions were observed in cardiovascular death (1.9% vs 3.6%; HR: 0.515; 95% CI: 0.269-0.983) and target-vessel revascularization (1.1% vs 3.0%; HR: 0.322; 95% CI: 0.143-0.727), whereas rates of nonfatal myocardial infarction and unplanned hospitalization for heart failure were similar between groups. Adverse events did not differ between groups.
Conclusions:
In patients with STEMI undergoing primary percutaneous coronary intervention, adjunctive intravenous nicorandil did not significantly reduce the 12-month primary composite outcome. These findings do not support routine use of intravenous nicorandil in unselected patients with STEMI. (Clinical Efficacy and sAfety of Intravenous Nicorandil; NCT04665648).
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