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

The CLEAN trial aimed to assess whether adjunctive intravenous nicorandil improves 12-month clinical outcomes in patients with STEMI undergoing primary percutaneous coronary intervention.

CLEAN试验旨在评估辅助静脉注射尼可地尔是否能改善接受初级经皮冠状动脉介入治疗的STEMI患者12个月的临床结果。

Methods

In this multicenter, randomized, double-blind, placebo-controlledtrial 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.

在这项在中国49家医院进行的多中心、随机、双盲、安慰剂对照试验中，18至80岁、在症状出现后12小时内发生STEMI的患者被随机分配（1:1）接受静脉注射尼可地尔（再灌注前6毫克负荷剂量，随后48小时内6毫克/小时输注）或匹配的安慰剂。

Oral nicorandil was prohibited during follow-up.

随访期间禁止口服尼可地尔。

The primary outcome was a composite of cardiovascular death, nonfatal myocardial infarction, target vessel revascularization, or unplanned hospitalization for heart failure within 12 months.

主要结果是在12个月内心血管死亡、非致命性心肌梗死、靶血管血运重建或因心力衰竭计划外住院的复合结果。

Results

Between January 2021 and December 2023, 1,503 patients were enrolled and randomly assigned to nicorandil (n = 748) or placebo (n = 755).

在2021年1月至2023年12月期间，共有1503名患者被纳入并随机分配到尼可地尔组（n = 748）或安慰剂组（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).

主要复合结果在尼可地尔组的98名患者（13.1%）中发生（717.2人年中113起事件），在安慰剂组的99名患者（13.1%）中发生（710.3人年中136起事件），两组之间没有显著差异（率比：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.

在次要结果中，观察到心血管死亡（1.9% vs 3.6%；HR：0.515；95% CI：0.269-0.983）和靶血管血运重建（1.1% vs 3.0%；HR：0.322；95% CI：0.143-0.727）的名义减少，而非致命性心肌梗死和因心力衰竭计划外住院的比率在两组之间相似。

Adverse events did not differ between groups.

不良事件在各组之间没有差异。

Conclusions

In patients with STEMI undergoing primary percutaneous coronary intervention, adjunctive intravenous nicorandil did not significantly reduce the 12-month primary composite outcome.

在进行原发性经皮冠状动脉介入治疗的ST段抬高型心肌梗死（STEMI）患者中，辅助性静脉注射尼可地尔并未显著降低12个月的主要复合结局事件。

These findings do not support routine use of intravenous nicorandil in unselected patients with STEMI.

这些发现不支持在未筛选的STEMI患者中常规使用静脉注射尼可地尔。

(Clinical Efficacy and sAfety of Intravenous Nicorandil; NCT04665648).

(静脉注射尼可地尔的临床疗效与安全性；NCT04665648)