A Phase 2A open label study to assess the pharmacodynamic and pharmacokinetic properties of a single subcutaneous injection of RUC-4 in patients with a ST-elevation myocardial infarction presenting to the cardiac catheterization lab with planned primary coronary angioplasty
RUC-4 (zalunfiban), an investigational drug, is a novel, promising and fast acting (5-15 minutes) GPIIbIIIa inhibitor with a high-grade inhibition of platelet aggregation (≥80%) shortly after subcutaneous administration. For patients with ST-elevation myocardial infarction (STEMI) early treatment with RUC-4 could be beneficial by improving initial patency of the infarct‑related vessel and by minimizing thrombotic occlusions, thus improving both coronary artery and myocardial microvascular blood flow, possibly resulting in a decrease in infarct size and a reduction in complications of STEMI.
The purpose of this phase 2A study was to assess the PD and PK properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the cardiac catheterization laboratory with planned coronary angioplasty. Additionally, the safety and tolerability were assessed at baseline and hospital discharge.
Clinical sites and inclusion
This study was conducted at the St. Antonius hospital (Nieuwegein, The Netherlands). Twenty-seven patients were entered to complete 8 evaluable patients in each of three cohorts at an initial starting dose of 0.075 mg/kg.
CeleCor Therapeutics Inc. is the study sponsor.
The Principal Investigator was prof. J.M. ten Berg, MD PhD (interventional cardiologist St. Antonius hospital, Nieuwegein and professor antithrombotic therapy in cardiac interventions, MUMC+, Maastricht, The Netherlands).
Co-principal investigator was prof. A.W.J. Van ‘t Hof, MD PhD (Head interventional cardiology, MUMC+, Maastricht).
Clinical trial information
For further details, see Clinicaltrials.gov.
- Bor WL, Zheng KL, Tavenier AH et al. Pharmacokinetics, pharmacodynamics, and tolerability of subcutaneous administration of a novel glycoprotein IIb/IIIa inhibitor, RUC-4, in patients with ST-segment elevation myocardial infarction. Eurointervention, May 18 2021. DOI: 10.4244/EIJ-D-21-00287
- Rikken SAOF, Bor WL, Selvarajah A et al. Prepercutaneous coronary intervention Zalunfiban dose-response relationship to target vessel blood flow at initial angiogram in st-elevation myocardial infarction – A post hoc analysis of the cel-02 phase IIa study. Am Heart J, 2023 Apr 22;262:75-82. doi: 10.1016/j.ahj.2023.04.009
- Results CEL-02 trial: interview prof. Michael Gibson, prof. Jur ten Berg and prof. Arnoud van ‘t Hof:
- Press release study sponsor (CeleCor Therapeutics)
- News item Diagram Research