Evaluation of the effect of trans sodium crocetinate and crocetin on reperfusion injury in acute myocardial infarction with ST-segment elevation: A double-blind, randomized, placebo-controlled clinical trial

Objective: This randomized, double-blind trial evaluated trans sodium crocetinate (TSC)—a crocetin-derived antioxidant and crocetin with potential cardioprotective effects—on reperfusion injury in 90 ST-elevation myocardial infarction (STEMI) patients after primary percutaneous coronary intervention (PPCI). Materials and Methods: Patients received either TSC (0.5 mg/kg injection pre-PPCI + 7.5 mg crocetin tablets for 3 days) or placebo. The primary outcome was ≥ 70% ST-segment resolution 1-hr post-PPCI. Secondary outcomes included corrected thrombolysis in myocardial infarction frame count (CTIMIFC), arrhythmia rates, and echocardiographic parameters (left ventricular ejection fraction (LVEF) and LV size). Results: ST-segment resolution occurrence was significantly higher in the TSC group versus placebo (p=0.018). There was no difference in CTIMIFC between the two groups. Echocardiographic parameters were similar between the TSC and placebo groups. Although not statistically significant, the frequency of supraventricular and ventricular arrhythmias was lower in the TSC group. Adverse drug effects were comparable between the two groups. Conclusion: TSC (0.5 mg/kg injection pre-PPCI + 7.5 mg crocetin tablets for 3 days) administration improved myocardial reperfusion, as evidenced by enhanced ST-segment resolution, suggesting reduced reperfusion injury in STEMI patients post-PPCI. While no benefits were observed in CTIMIFC or cardiac remodeling, the safety profile and primary outcome results support further investigation. Larger trials are needed to confirm efficacy and assess long-term clinical impacts.