NCT04284995

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 26, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

June 2, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 8, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2020

Completed
Last Updated

February 3, 2021

Status Verified

February 1, 2021

Enrollment Period

5 months

First QC Date

February 22, 2020

Last Update Submit

February 1, 2021

Conditions

Coronary DiseaseMyocardial InfarctionHeart DiseasesVascular DiseasesSTEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (17)

  • Platelet Inhibition

    Inhibition of Platelet Aggregation

    Baseline

  • Platelet Inhibition

    Inhibition of Platelet aggregation

    15 minutes

  • Platelet inhibition

    Inhibition of Platelet aggregation

    45 minutes

  • Platelet inhibition

    Inhibition of Platelet aggregation

    60 minutes

  • Platelet inhibition

    Inhibition of Platelet aggregation

    90 minutes

  • Platelet inhibition

    Inhibition of Platelet aggregation

    120 minutes

  • Platelet inhibition

    Inhibition of Platelet aggregation

    180 minutes

  • RUC-4 Concentration

    concentration in blood (ng/mL)

    Baseline

  • RUC-4 Concentration

    concentration in blood (ng/mL)

    15 minutes

  • RUC-4 Concentration

    concentration in blood (ng/mL)

    45 minutes

  • RUC-4 Concentration

    concentration in blood (ng/mL)

    90 minutes

  • RUC-4 Concentration

    concentration in blood (ng/mL)

    120 minutes

  • RUC-4 Concentration

    concentration in blood (ng/mL)

    180 minutes

  • Safety and Tolerability

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

    Baseline

  • Safety and Tolerability

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

    Hospital discharge

  • RUC-4 Concentration

    concentration in blood (ng/mL)

    240 minutes

  • Platelet aggregation

    Inhibition of platelet aggregation

    240 minutes

Study Arms (3)

Cohort 1

EXPERIMENTAL

Cohort 1: 0.075 mg/kg RUC-4. 8 STEMI Patients will be enrolled.

Drug: RUC-4 Compound

Cohort 2

EXPERIMENTAL

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

Cohort 3

EXPERIMENTAL

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

Interventions

RUC-4 CompoundDRUG

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

Cohort 1Cohort 2Cohort 3

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Antonius hospital

Nieuwegein, CM, 3435, Netherlands

Location

MeSH Terms

Conditions

Coronary DiseaseMyocardial InfarctionHeart DiseasesVascular DiseasesST Elevation Myocardial Infarction

Interventions

RUC-4 compound

Condition Hierarchy (Ancestors)

Myocardial IschemiaCardiovascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2020

First Posted

February 26, 2020

Study Start

June 2, 2020

Primary Completion

November 8, 2020

Study Completion

December 14, 2020

Last Updated

February 3, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)