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

Myocardial Infarction Clinical Trial

— CEL-02  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04284995
• Other study ID #: CEL-02
• Status: Completed
• Phase: Phase 2
• Start date: June 2, 2020
• Est. completion date: December 14, 2020

Study information

• Verified date: February 2021
• Source: CeleCor Therapeutics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 14, 2020
• Est. primary completion date: November 8, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 aIIbß3 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

Related Conditions & MeSH terms

• Coronary Disease
• Heart Diseases
• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction
• Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
Netherlands	St. Antonius hospital	Nieuwegein	CM

Sponsors (3)

Lead Sponsor	Collaborator
CeleCor Therapeutics	Diagram B.V., ST. Antonius hospital Nieuwegein

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Platelet Inhibition	Inhibition of Platelet Aggregation	Baseline
Primary	Platelet Inhibition	Inhibition of Platelet aggregation	15 minutes
Primary	Platelet inhibition	Inhibition of Platelet aggregation	45 minutes
Primary	Platelet inhibition	Inhibition of Platelet aggregation	60 minutes
Primary	Platelet inhibition	Inhibition of Platelet aggregation	90 minutes
Primary	Platelet inhibition	Inhibition of Platelet aggregation	120 minutes
Primary	Platelet inhibition	Inhibition of Platelet aggregation	180 minutes
Primary	RUC-4 Concentration	concentration in blood (ng/mL)	Baseline
Primary	RUC-4 Concentration	concentration in blood (ng/mL)	15 minutes
Primary	RUC-4 Concentration	concentration in blood (ng/mL)	45 minutes
Primary	RUC-4 Concentration	concentration in blood (ng/mL)	90 minutes
Primary	RUC-4 Concentration	concentration in blood (ng/mL)	120 minutes
Primary	RUC-4 Concentration	concentration in blood (ng/mL)	180 minutes
Primary	Safety and Tolerability	Bleeding events, Injection site reactions,vital signs, ECG, laboratory results	Baseline
Primary	Safety and Tolerability	Bleeding events, Injection site reactions,vital signs, ECG, laboratory results	Hospital discharge
Primary	RUC-4 Concentration	concentration in blood (ng/mL)	240 minutes
Primary	Platelet aggregation	Inhibition of platelet aggregation	240 minutes