RUC-4 is a novel, promising and fast acting (5-15 minutes) αIIbβ3 receptor antagonist with a high-grade inhibition of platelet aggregation (≥80%) shortly after subcutaneous administration. This study is designed to extend the findings in CEL-01 to patients with ST-elevation myocardial Infarction (STEMI) presenting to the cardiac catheterization laboratory with planned coronary angioplasty.
RUC-4 is a novel, promising and fast acting (5-15 minutes) αIIbβ3 receptor antagonist 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 study is 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. In addition the safety and tolerability will be assessed at baseline and hospital discharge.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
27
All patients will receive a single subcutaneous dose of RUC-4 in the Cardiac Catheterization Lab (CCL) before coronary angiography/percutaneous coronary intervention.
St. Antonius hospital
Nieuwegein, CM, Netherlands
Platelet Inhibition
Inhibition of Platelet Aggregation
Time frame: Baseline
Platelet Inhibition
Inhibition of Platelet aggregation
Time frame: 15 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Time frame: 45 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Time frame: 60 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Time frame: 90 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Time frame: 120 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Time frame: 180 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Time frame: Baseline
RUC-4 Concentration
concentration in blood (ng/mL)
Time frame: 15 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Time frame: 45 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Time frame: 90 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Time frame: 120 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Time frame: 180 minutes
Safety and Tolerability
Bleeding events, Injection site reactions,vital signs, ECG, laboratory results
Time frame: Baseline
Safety and Tolerability
Bleeding events, Injection site reactions,vital signs, ECG, laboratory results
Time frame: Hospital discharge
RUC-4 Concentration
concentration in blood (ng/mL)
Time frame: 240 minutes
Platelet aggregation
Inhibition of platelet aggregation
Time frame: 240 minutes
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.