Coronary DiseasePhase 2CEL-02NCT04284995
A Phase 2 Open Label Study to Assess the PK/PD Properties of RUC-4 in Patients With a ST-elevation Myocardial Infarction
A Phase 2 study testing RUC-4 Compound in people with Coronary Disease and Myocardial Infarction, run by CeleCor Therapeutics at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease, Myocardial Infarction, Heart Diseases
- What is being tested?
- RUC-4 Compound
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteNetherlands
- Study dates
- 2 Jun 2020to 14 Dec 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Coronary Disease, Myocardial Infarction, Heart Diseases, Vascular Diseases, STEMI - ST Elevation Myocardial Infarction
- Being tested
- RUC-4 Compound
- Medical subject headings
- Coronary Disease, Myocardial Infarction, Heart Diseases, Vascular Diseases, ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Cohort 1: 0.075 mg/kg RUC-4. 8 STEMI Patients will be enrolled. Receives: 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. Receives: 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. Receives: Drug: RUC-4 Compound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet Inhibition
Inhibition of Platelet Aggregation
Measured: Baseline
Platelet Inhibition
Inhibition of Platelet aggregation
Measured: 15 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Measured: 45 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Measured: 60 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Measured: 90 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Measured: 120 minutes
Platelet inhibition
Inhibition of Platelet aggregation
Measured: 180 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Measured: Baseline
RUC-4 Concentration
concentration in blood (ng/mL)
Measured: 15 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Measured: 45 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Measured: 90 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Measured: 120 minutes
RUC-4 Concentration
concentration in blood (ng/mL)
Measured: 180 minutes
Safety and Tolerability
Bleeding events, Injection site reactions,vital signs, ECG, laboratory results
Measured: Baseline
Safety and Tolerability
Bleeding events, Injection site reactions,vital signs, ECG, laboratory results
Measured: Hospital discharge
RUC-4 Concentration
concentration in blood (ng/mL)
Measured: 240 minutes
Platelet aggregation
Inhibition of platelet aggregation
Measured: 240 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2020
- Study start2 Jun 2020
- Primary completion8 Nov 2020
- Study completion14 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- CeleCor Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- St. Antonius Hospital, Diagram B.V.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04284995
- Sponsor's protocol ID
- CEL-02
- Acronym
- CEL-02
- Status last verified
- Feb 2021
- First submitted
- 22 Feb 2020
- Last updated
- 3 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04284995
- Acronym / sponsor ID
- CEL-02 / CEL-02
- Conditions
- Coronary Disease, Myocardial Infarction, Heart Diseases, Vascular Diseases, STEMI - ST Elevation Myocardial Infarction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- CeleCor TherapeuticsIndustry (pharma, biotech, devices)
- Collaborators
- St. Antonius Hospital, Diagram B.V.
- Study start
- 2 Jun 2020 (actual)
- Primary completion
- 8 Nov 2020 (actual)
- Study completion
- 14 Dec 2020 (actual)
- First posted
- 26 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Drug: RUC-4 CompoundCohort 1: 0.075 mg/kg RUC-4. 8 STEMI Patients will be enrolled. |
| Cohort 2 | Experimental | Drug: RUC-4 CompoundCohort 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. |
| Cohort 3 | Experimental | Drug: RUC-4 CompoundCohort 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (20 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RUC-4 CompoundAll patients will receive a single subcutaneous dose of RUC-4 in the Cardiac Catheterization Lab (CCL) before coronary angiography/percutaneous coronary intervention. | Drug | Cohort 1, Cohort 2, Cohort 3 |
Primary outcome
Platelet Inhibition
Time frame: Baseline
Inhibition of Platelet Aggregation
Platelet Inhibition
Time frame: 15 minutes
Inhibition of Platelet aggregation
Platelet inhibition
Time frame: 45 minutes
Inhibition of Platelet aggregation
Platelet inhibition
Time frame: 60 minutes
Inhibition of Platelet aggregation
Platelet inhibition
Time frame: 90 minutes
Inhibition of Platelet aggregation
Platelet inhibition
Time frame: 120 minutes
Inhibition of Platelet aggregation
Platelet inhibition
Time frame: 180 minutes
Inhibition of Platelet aggregation
RUC-4 Concentration
Time frame: Baseline
concentration in blood (ng/mL)
RUC-4 Concentration
Time frame: 15 minutes
concentration in blood (ng/mL)
RUC-4 Concentration
Time frame: 45 minutes
concentration in blood (ng/mL)
RUC-4 Concentration
Time frame: 90 minutes
concentration in blood (ng/mL)
RUC-4 Concentration
Time frame: 120 minutes
concentration in blood (ng/mL)
RUC-4 Concentration
Time frame: 180 minutes
concentration in blood (ng/mL)
Safety and Tolerability
Time frame: Baseline
Bleeding events, Injection site reactions,vital signs, ECG, laboratory results
Safety and Tolerability
Time frame: Hospital discharge
Bleeding events, Injection site reactions,vital signs, ECG, laboratory results
RUC-4 Concentration
Time frame: 240 minutes
concentration in blood (ng/mL)
Platelet aggregation
Time frame: 240 minutes
Inhibition of platelet aggregation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RUC-4 Compound in people with Coronary Disease and Myocardial Infarction, run by CeleCor Therapeutics at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet Inhibition (time frame: Baseline). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2021.