Intravenous Nicorandil in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI: The CLEAN Randomized Clinical Trial
Primary resultResult — go to the resultRate ratio 0.869 95% CI 0.650–1.162Authors' conclusion
In patients with STEMI undergoing primary percutaneous coronary intervention, adjunctive intravenous nicorandil did not significantly reduce the 12-month primary composite outcome.
Study context
- Population
- Patients aged 18 to 80 years with STEMI within 12 hours of symptom onset undergoing primary PCI
- Participants
- 1,503 patients
- Comparison
- Adjunctive IV nicorandil vs placebo
- Nicorandiln = 748
- Placebon = 755reference
- Primary endpoint
- CV death, nonfatal MI, target vessel revascularization or unplanned HF hospitalization
- Follow-up
- 12 months
Methodological detailsmulticentre, double-blind, placebo-controlled, 49 hospitals in China
- Multicentre
- Double-blind
- Placebo-controlled
- 49 hospitals in China
Primary result
As reported in the abstract
Rate ratio
0.869
95% CI 0.650–1.162
P = 0.3429
Events by treatment group
Nicorandil vs Placebo
rate ratio 0.869 (95% CI 0.650–1.162); P = 0.3429
Secondary outcomes
CV death · 12 months
- CV death 1.9% vs 3.6%; HR
- 0.515 (95% CI 0.269-0.983)
- Nominal reduction
Target-vessel revascularization · 12 months
- Target-vessel revascularization 1.1% vs 3.0%; HR
- 0.322 (95% CI 0.143-0.727)
- Nominal reduction
Nonfatal MI, unplanned hospitalization for HF · 12 months
- Rates similar between groups
Safety
Adverse events
- Did not differ between groups
Original publication
Intravenous Nicorandil in Patients With ST-Segment Elevation Myocardial Infarction Undergoing Primary PCI: The CLEAN Randomized Clinical Trial. J Am Coll Cardiol. Published 12 August 2026. doi:10.
Summarised from the published abstract; every number is checked against it