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Completed

NCT Number: NCT04284995

A Phase 2 Open Label Study to Assess the PK/PD Properties of RUC-4 in Patients With a ST-elevation Myocardial Infarction

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.

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Key information

Conditions

Coronary Disease Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction STEMI - ST Elevation Myocardial Infarction Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

St. Antonius hospital

Nieuwegein, CM, 3435, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 symptoms 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) by history and review of medical record
  • Weight (by history) of between 52 and 120 kg
  • Written informed consent (following short-form of the informed consent form at Cardiac Catheterization Lab)

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 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)
  • Current active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines)
  • 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})
  • Current treatment with αIIbβ3 receptor antagonist (other than RUC-4)
  • Coagulation abnormality, known bleeding disorder, or history of documented prior hemorrhagic or thrombotic stroke within the past 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

Treatment and study plan

RUC-4 Compound

Drug

All patients will receive a single subcutaneous dose of RUC-4 in the Cardiac Catheterization Lab (CCL) before coronary angiography/percutaneous coronary intervention.

Primary outcomes

  1. Platelet Inhibition

    Time frame: Baseline

    Inhibition of Platelet Aggregation

  2. Platelet Inhibition

    Time frame: 15 minutes

    Inhibition of Platelet aggregation

  3. Platelet inhibition

    Time frame: 45 minutes

    Inhibition of Platelet aggregation

  4. Platelet inhibition

    Time frame: 60 minutes

    Inhibition of Platelet aggregation

  5. Platelet inhibition

    Time frame: 90 minutes

    Inhibition of Platelet aggregation

  6. Platelet inhibition

    Time frame: 120 minutes

    Inhibition of Platelet aggregation

  7. Platelet inhibition

    Time frame: 180 minutes

    Inhibition of Platelet aggregation

  8. RUC-4 Concentration

    Time frame: Baseline

    concentration in blood (ng/mL)

  9. RUC-4 Concentration

    Time frame: 15 minutes

    concentration in blood (ng/mL)

  10. RUC-4 Concentration

    Time frame: 45 minutes

    concentration in blood (ng/mL)

  11. RUC-4 Concentration

    Time frame: 90 minutes

    concentration in blood (ng/mL)

  12. RUC-4 Concentration

    Time frame: 120 minutes

    concentration in blood (ng/mL)

  13. RUC-4 Concentration

    Time frame: 180 minutes

    concentration in blood (ng/mL)

  14. Safety and Tolerability

    Time frame: Baseline

    Bleeding events, Injection site reactions,vital signs, ECG, laboratory results

  15. Safety and Tolerability

    Time frame: Hospital discharge

    Bleeding events, Injection site reactions,vital signs, ECG, laboratory results

  16. RUC-4 Concentration

    Time frame: 240 minutes

    concentration in blood (ng/mL)

  17. Platelet aggregation

    Time frame: 240 minutes

    Inhibition of platelet aggregation

Sponsors and collaborators

Lead sponsor

CeleCor Therapeutics

Industry

Collaborators

  • Diagram B.V.
  • St. Antonius Hospital

Registry information

Official study title

A Phase 2 Open Label Study to Assess the PK and PD 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

Acronym: CEL-02

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2020
Registry last updated
Feb 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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