Patients with STEMI, presenting with persistent chest pain (>30 min) and = 1 mm ST-segment elevation in two adjacent electrocardiograph leads, with > 6 mm cumulative ST-segment deviation, in whom the total duration of symptom to first intracoronary device deployment (excluding a wire) is anticipated to be within 6 hours. Patients are adult males and females 18 years of age or older. MedDRA version: 20.0 Level: HLGT Classification code 10028593 Term: Myocardial disorders System Organ Class: 100
Conditions
Interventions
Product Name: RUC-4
Product Code: 140962
Pharmaceutical Form: Concentrate and solvent for solution for injection
INN or Proposed INN: RUC-4
Current Sponsor code: RUC-4
Other descriptive name: GLYCOPRO
Sponsors
CeleCor Therapeutics, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients with STEMI, presenting with persistent chest pain (>30 min) and = 1 mm ST-segment elevation in two adjacent ECG-leads, with > 6 mm cumulative ST-segment deviation, in whom the total duration of symptom to first intracoronary device deployment (excluding a wire) is anticipated to be within 6 hours - Adult males and females 18 years of age or older - Females must be non-pregnant, non-lactating, and of non-childbearing potential (postmenopausal or surgically sterilized) - Weight (by history) of between 52 and 120 kg - Written informed consent (following short-form of the informed consent form at CCL) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: - High probability in the opinion of the cardiologist that current STEMI is caused by stent thrombosis and the previous PCI related to this stent thrombosis is 30 minutes) - Persistent severe hypertension (systolic blood pressure > 180 mm Hg or diastolic blood pressure > 110 mm Hg) - Known severe liver disease - Known history of severe renal dysfunction (glomerular filtration rate 200 mmol/L [> 2.5 mg/dL]) - Known left bundle branch block - Requirement of oral anticoagulation (Vitamin K antagonists {VKA} or direct oral antagonists {DOACs}) - Chronic use of P2Y12 antagonists - Current treatment with aIIbß3 receptor antagonist (other than RUC-4) - Coagulation abnormality, known bleeding disorder, or history of documented prior hemorrhagic or thrombotic stroke < 6 months - History of upper or lower GI bleeding within the past 6 months - Known clinically important anemia - Known clinically important thrombocytopenia (platelet count of less than 150,000/µL) - Known history of allergy to any of the ingredients in the RUC-4 formulation (i.e., acetate buffer, sucrose) - Major surgery within the past 6 months - Life expectancy of less than 6 months - Any clinically significant abnormality identified prior to enrollment that in the judgment of the Investigator would preclude safe completion of the study - Unwillingness or inability to comply with the requirements of this protocol including the presence of any condition (physical, mental, or social) that is likely to affect the patient’s ability to comply with the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To assess the PD properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the CCL with the aim to perform primary coronary angioplasty. - To assess the PK properties of a single subcutaneous injection of RUC-4 in STEMI patients presenting to the CCL with the aim to perform primary coronary angioplasty. - To assess safety and tolerability of RUC-4;Secondary Objective: - To assess platelet count at select time points before and after RUC-4 administration - To assess bleeding events* of a single SC injection of RUC-4 at select timepoints after RUC-4 administration, at discharge and at 15-day and at 30-day follow-up - To assess intraprocedural thrombosis - To assess the injection site reactions of a single subcutaneous injection of RUC-4 at select timepoints after RUC-4 administration and at 15-day and at 30-day follow-up - To evaluate any differences in PD or PK within each treatment group (gender, weight, BMI, age) * According to the BARC (II, III and V), ISTH Major and TIMI Major criteria;Primary end point(s): - Inhibition of thrombin receptor activating peptide (TRAP)-induced platelet aggregation (%) assessed by VerifyNow at baseline, and at 15, 45, 60, 90, 120, 180 and 240 minutes after administration of RUC-4 (the 240 minute time point is only applicable if the RUC-4 dose is increased in cohort 2 and/or 3) - RUC-4 concentration (ng/mL) versus time profiles (at baseline and at 15, 45, 90, 120 and 180 minutes after administration of RUC 4) and associated PK parameters - Safety and tolerability parameters at baseline and at hospital discharge;Timepoint(s) of evaluation of this end point: see primary end points (E.5.1) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Platelet count (µL) at baseline, and at 15, 45, 90, 120 and 180 minutes after administration of RUC-4 and at hospital discharge - Bleeding events (according to BARC II, III and V criteria for safety assessment and according to ISTH Major and TIMI Major for information only) at baseline, discharge and at 15-day and 30-day follow-up - Intraprocedural thrombosis (assessed by PI) - Injection site reactions at baseline, 1-hour post-PCI, hospital discharge, and at 15-day and 30-day follow-up - Inhibition of ADP-induced platelet aggregation (%) assessed by VerifyNow at baseline, and at 15, 45, 60, 90, 120, 180 and 240 minutes after administration of RUC-4 (the 240 minute time point is only applicable if the RUC-4 dose is increased in cohort 2 and/or 3) - Differences in PD or PK among the patients (gender, weight, BMI, age);Timepoint(s) of evaluation of this end point: see secondary end points (E.5.2) | — |
Countries
Netherlands
Contacts
Public ContactS. Postma
Diagram BV
Outcome results
None listed