A Phase-2 open label study to assess the pharmacodynamic and pharmacokinetic properties of a single subcutaneous injection of RUC-4 in patients with ST-elevation myocardial infarction presenting to cardiac catheterization lab with planned primary coronary angioplasty

Phase 2

Completed

Conditions: heart attack
ST-elevation myocardial infarction
10028593

Registration Number: NL-OMON49794

Lead Sponsor: CeleCor Therapeutics, Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 30

Inclusion Criteria

- Patients with STEMI, presenting with persistent chest pain (>30 min) and
ongoing >= 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)

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 < 1 month
- High suspicion of COVID-19 infection (known exposure, hypoxia, fever, cough)
- High suspicion of type II MI
- Out of hospital cardiac arrest (OHCA)
- Therapy resistant cardiogenic shock (systolic blood pressure <= 80 mm Hg for >
30 minutes)
- Persistent severe hypertension (systolic blood pressure > 180 mm Hg or
diastolic blood pressure > 110 mm Hg)
- Presentation with atrial fibrillation de novo
- Known severe liver disease
- Known history of severe renal dysfunction (glomerular filtration rate < 30
mL/min or serum creatinine > 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 aIIbβ3 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.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- Inhibition of TRAP-induced platelet aggregation (%) assessed by VerifyNow at<br /><br>baseline, and at 15, 45, 60, 90, 120, 180 and 240 minutes after administration<br /><br>of RUC-4 (the 240 minute time point is only applicable if the RUC-4 dose is<br /><br>increased in cohort 2 and/or 3)<br /><br>- RUC-4 concentration (ng/mL) versus time profiles (at baseline and at 15, 45,<br /><br>90, 120 and 180 minutes after administration of RUC 4) and associated PK<br /><br>parameters<br /><br>- Safety and tolerability parameters at baseline and at hospital discharge</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Platelet count (µL) at baseline, and at 15, 45, 90, 120 and 180 minutes after<br /><br>administration of RUC-4 and at hospital discharge<br /><br>- Bleeding events (according to BARC II, III and V criteria for safety<br /><br>assessment and according to ISTH Major and TIMI Major for information only) at<br /><br>baseline, discharge and at 15-day and at 30-day follow-up<br /><br>- Intraprocedural thrombosis (assessed by PI)<br /><br>- Injection site reactions at baseline, 1-hour post-PCI, hospital discharge,<br /><br>and at 15-day and at 30-day follow-up<br /><br>- Inhibition of ADP-induced platelet aggregation (%) assessed by VerifyNow at<br /><br>baseline, and at 15, 45, 60, 90, 120, 180 and 240 minutes after administration<br /><br>of RUC-4 (the 240 minute time point is only applicable if the RUC-4 dose is<br /><br>increased in cohort 2 and/or 3)<br /><br>- Differences in PD or PK among the patients (gender, weight, BMI, age)</p><br>