Intravenous Nicorandil in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI: The CLEAN...

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.