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A Phase 2 Open Label Study to Assess the PK/PD Properties of RUC-4 in Patients With a ST-elevation Myocardial Infarction (CEL-02)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04284995
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : September 29, 2020
Sponsor:
Collaborators:
ST. Antonius hospital Nieuwegein
Diagram B.V.
Information provided by (Responsible Party):
CeleCor Therapeutics

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Coronary Disease Myocardial Infarction Heart Diseases Vascular Diseases STEMI - ST Elevation Myocardial Infarction Drug: RUC-4 Compound Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : September 30, 2020
Estimated Study Completion Date : October 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack

Arm Intervention/treatment
Experimental: Cohort 1
Cohort 1: 0.075 mg/kg RUC-4. 8 STEMI Patients will be enrolled.
Drug: RUC-4 Compound
All patients will receive a single subcutaneous dose of RUC-4 in the Cardiac Catheterization Lab (CCL) before coronary angiography/percutaneous coronary intervention.

Experimental: Cohort 2
Cohort 2: Dose of RUC-4 selected by Safety Review Committee (SRC) after completion of Cohort 2 and review of data. 8 STEMI Patients will be enrolled.
Drug: RUC-4 Compound
All patients will receive a single subcutaneous dose of RUC-4 in the Cardiac Catheterization Lab (CCL) before coronary angiography/percutaneous coronary intervention.

Experimental: Cohort 3
Cohort 3: Dose of RUC-4 selected by Safety Review Committee (SRC) after completion of Cohort 2 and review of data. 8 STEMI Patients will be enrolled.
Drug: RUC-4 Compound
All patients will receive a single subcutaneous dose of RUC-4 in the Cardiac Catheterization Lab (CCL) before coronary angiography/percutaneous coronary intervention.




Primary Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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
  2. Adult males and females 18 years of age or older
  3. Females must be non-pregnant, non-lactating, and of non-childbearing potential (postmenopausal or surgically sterilized) by history and review of medical record
  4. Weight (by history) of between 52 and 120 kg
  5. Written informed consent (following short-form of the informed consent form at Cardiac Catheterization Lab)

Exclusion Criteria:

  1. 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
  2. High suspicion of type II MI
  3. Out of hospital cardiac arrest (OHCA)
  4. Therapy resistant cardiogenic shock (systolic blood pressure ≤80 mm Hg for >30 minutes)
  5. Persistent severe hypertension (systolic blood pressure >180 mm Hg or diastolic blood pressure >110 mm Hg)
  6. Current active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines)
  7. Known severe liver disease
  8. Known history of severe renal dysfunction (glomerular filtration rate <30 mL/min or serum creatinine >200 mmol/L [>2.5 mg/dL])
  9. Known left bundle branch block
  10. Requirement of oral anticoagulation (Vitamin K antagonists {VKA} or direct oral antagonists {DOACs})
  11. Current treatment with αIIbβ3 receptor antagonist (other than RUC-4)
  12. Coagulation abnormality, known bleeding disorder, or history of documented prior hemorrhagic or thrombotic stroke within the past 6 months
  13. History of upper or lower GI bleeding within the past 6 months
  14. Known clinically important anemia
  15. Known clinically important thrombocytopenia (platelet count of less than 150,000/μL)
  16. Known history of allergy to any of the ingredients in the RUC-4 formulation (i.e., acetate buffer, sucrose)
  17. Major surgery within the past 6 months
  18. Life expectancy of less than 6 months
  19. Any clinically significant abnormality identified prior to enrollment that in the judgment of the Investigator would preclude safe completion of the study
  20. 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04284995


Contacts
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Contact: Robert Hillman, PhD 858-777-9750 contact@celecor.com

Locations
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Netherlands
St. Antonius hospital Recruiting
Nieuwegein, CM, Netherlands, 3435
Contact: J.M Ten Berg, MD PhD         
Principal Investigator: J.M. Ten Berg, MD PhD         
Sub-Investigator: A.W.J Van't Hof, MD PhD         
Sponsors and Collaborators
CeleCor Therapeutics
ST. Antonius hospital Nieuwegein
Diagram B.V.
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Responsible Party: CeleCor Therapeutics
ClinicalTrials.gov Identifier: NCT04284995    
Other Study ID Numbers: CEL-02
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: September 29, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Heart Diseases
Myocardial Infarction
Vascular Diseases
Coronary Disease
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Cardiovascular Diseases
Myocardial Ischemia