The CELEBRATE (CeleCor Blinded Randomized Trial in ST-Elevation Myocardial Infarction) trial was a phase 3, multicenter, double-blind, placebo-controlled study that evaluated the efficacy and safety of a single subcutaneous injection of zalunfiban (CeleCor Therapeutics), a novel glycoprotein IIb/IIIa inhibitor, compared with placebo administered at the first point of medical contact in patients with ST-segment elevation myocardial infarction (STEMI) intended for percutaneous coronary intervention (PCI).¹ The trial results demonstrated a significant improvement in infarct-vessel patency and a reduction in adverse 30-day clinical outcomes among patients receiving zalunfiban compared with placebo.

A total of 2,467 patients were randomly assigned to one of three groups: 853 patients received zalunfiban 0.11 mg/kg, 818 received zalunfiban 0.13 mg/kg, and 796 received a placebo. The mean age was 63 years and 79% of the participants were male. The primary efficacy endpoint was a composite of all-cause death, stroke, recurrent myocardial infarction, acute stent thrombosis, hospitalization for heart failure, larger infarction size, or absence of adverse effects at 30 days. The primary safety endpoint was the occurrence of severe or life-threatening bleeding events, as defined by the GUSTO (Global Use of Strategies to Open Occluded Coronary Arteries) criteria. At 30 days, the treatment group had significantly lower odds of the composite major adverse event (adjusted odds ratio, 0.79; 95% confidence interval, 0.65-0.98; p = 0.028) than the placebo group. The secondary outcome (blood flow in the infarct-related artery at initial angiography) improved in the treatment group. The incidence of severe or life-threatening bleeding was similar between the zalunfiban and placebo groups (1.2% vs. 0.8%; p = 0.4), although mild-to-moderate bleeding was more frequent in the zalunfiban group (6.4% vs. 2.5%; p > 0.001).¹

This trial builds on a previous phase 2 trial that used lower doses of zalunfiban and is consistent with findings from the ADMIRAL (Platelet Glycoprotein IIb/IIIa Inhibition With Coronary Stenting For Acute Myocardial Infarction) and On-TIME 2 (Ongoing Tirofiban in Myocardial Infarction Evaluation 2 Trial) trials, whose findings demonstrated improved reperfusion with early abciximab and tirofiban pretreatment plus continuous infusion.^2,3 In contrast, the CELEBRATE trial findings showed the safety and efficacy of a single prehospital zalunfiban injection in a contemporary STEMI population undergoing PCI with current standard-of-care practices. Notable limitations of this trial included a short follow-up period and a low proportion of female participants.

References

1. Van't Hof AWJ, Gibson CM, Rikken SAOF, et al. Zalunfiban at first medical contact for ST-elevation myocardial infarction. NEJM Evid. 2026;5(1):EVIDoa2500268. doi:10.1056/EVIDoa2500268
2. Dominguez J, Kanna B. Three-year duration of benefit from abciximab in patient receiving stents for acute myocardial infarction in the randomized double-blind ADMIRAL study. Eur Heart J. 2006;27(12):1508-1509. doi:10.1093/eurheartj/ehl008
3. Rikken SAOF, Fabris E, Rosenqvist T, et al. Prehospital tirofiban increases the rate of disrupted myocardial infarction in patients with ST-segment elevation myocardial infarction: insights from the On-TIME 2 trial. Eur Heart J Acute Cardiovasc Care. 2024;13(8):595-601. doi:10.1093/ehjacc/zuae074