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A Phase 2B Study of RUC-4 in Subjects With ST-elevation MI (CELEBRATE)

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ClinicalTrials.gov Identifier: NCT04825743
Recruitment Status : Recruiting
First Posted : April 1, 2021
Last Update Posted : May 13, 2021
Sponsor:
Information provided by (Responsible Party):
CeleCor Therapeutics

Brief Summary:
This is a Phase 2B prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by highly trained paramedics who transport the subjects to the participating hospitals in the Netherlands and the Czech Republic. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either RUC-4 Dose 1 (0.110 mg/kg) or RUC-4 Dose 2 (0.130 mg/kg) or placebo

Condition or disease Intervention/treatment Phase
ST-elevation Myocardial Infarction (STEMI) Drug: RUC-4 Drug: Placebo Phase 2

Detailed Description:

Subjects will be screened in the ambulance based on the information available; those fulfilling the eligibility criteria who have provided verbal witnessed/short written informed consent will be randomized and enrolled in the study. Following a single weight-based dose of subcutaneous study drug by the ambulance staff, the patient will be transferred to the clinical site PCI center for angiography and intervention.

Regular standard of care is performed from the provision of informed consent through the last study mandated subject visit. Concomitant medications will be recorded. Treatment with IV P2Y12 antagonists or other αIIbβ3 receptor before PCI/angiography is prohibited. Demographics, concomitant medications, vital signs, and medical history will be collected in the CRF. Adverse events, bleeding events and injection site reactions will be collected. Angiography and PCI details will be recorded. Full written informed consent will be obtained. Additional blood samples for safety will be collected at 1, 6, 24 and 72 hours (or hospital discharge) post-PCI/angiography. Blood samples for high-sensitive cardiac troponin T (upon arrival and 24 hours post PCI/angiography) and NT-ProBNP (24 hours post PCI/angiography) will be assessed by central laboratory. Follow up phone contacts will occur at 1 month to report AEs, bleeding events, and injection site reactions, and 12-months to record mortality, and hospitalizations for heart failure or atrial fibrillation.

Angiography/PCI data and ECGs will be evaluated at independent Core Laboratories. An independent, blinded Clinical Events Committee will provide central adjudication of all clinical endpoint events. A DSMB will examine the safety data in an ongoing manner and to alert the Steering Committee in case of clinically concerning safety issues that should lead to consideration of altering the trial, and can recommend modification of the study protocol based on pre-specified rules.

The duration of participation for each subject will be 12 months (± 1 month), including enrollment, study drug administration, hospitalization, and phone contact follow-up at 1 and 12 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1668 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2B Prospective, Blinded, Randomized, Placebo Controlled, Multicenter Study to Assess Restoration of Coronary Artery Blood Flow and Resolution of ST Segment Deviation After a Single SQ Injection of RUC-4 in Subjects With ST-elevation MI Presenting in the Ambulance (Pre-hospital Setting)
Actual Study Start Date : April 24, 2021
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : June 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: RUC-4 Dose 1 (0.110 mg/kg)
Subjects will receive a single subcutaneous injection containing RUC-4 Dose 1 (0.110 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival
Drug: RUC-4
RUC-4 is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).
Other Name: zalunfiban

Experimental: RUC-4 Dose 2 (0.130 mg/kg)
Subjects will receive a single subcutaneous injection containing RUC-4 Dose 2 (0.130 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival
Drug: RUC-4
RUC-4 is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).
Other Name: zalunfiban

Placebo Comparator: Placebo
Subjects will receive a single subcutaneous injection containing Placebo in the ambulance after diagnosis of STEMI and before hospital arrival
Drug: Placebo
Single-use vials and syringes in randomization kits containing RUC-4 Dose 1 (0.110 mg/kg), RUC-4 Dose 2 (0.130 mg/kg), or placebo will be dispensed in the ambulance




Primary Outcome Measures :
  1. primary efficacy-restoration of the coronary artery blood flow [ Time Frame: before PCI (or coronary angiography if no PCI is performed) ]
    To assess restoration of the coronary artery blood flow (corrected Thrombolysis in Myocardial Infarction [TIMI] Frame Count) before intended PCI (or post coronary angiography in case no PCI is performed) after a single subcutaneous injection of RUC-4 versus placebo in STEMI subjects in the ambulance (pre-hospital setting)

  2. primary efficacy-resolution of ST segment deviation [ Time Frame: 1 hour post-PCI/angiography ]
    To assess resolution of ST segment deviation post-PCI/angiography after a single subcutaneous injection of RUC-4 versus placebo in STEMI subjects in the ambulance (pre-hospital setting)

  3. primary safety- bleeding events [BARC criteria] [ Time Frame: after a single subcutaneous injection of RUC-4 versus placebo up to 1 month post-PCI/angiography ]
    • To assess bleeding events (according to Global Use of Strategies to Open Occluded Coronary Arteries [GUSTO] severe or life threatening criterion for safety assessment and according to the Bleeding Academic Research Consortium [BARC] 3C and 5 criteria for information only)


Secondary Outcome Measures :
  1. Efficacy-composite of all cause death, recurrent MI, urgent TVR or blinded bail-out use of IV αIIbβ3 antagonists or intravenous P2Y12 antagonist [ Time Frame: up to 1 month post-PCI/angiography ]
    To assess a composite of all cause death, recurrent MI, urgent TVR or blinded bail-out use of IV αIIbβ3 antagonists or intravenous P2Y12 antagonist after a single subcutaneous injection of RUC-4 versus placebo

  2. Efficacy-acute stent thrombosis [ Time Frame: up to 24 hours post-PCI ]
    To assess acute stent thrombosis after a single subcutaneous injection of RUC-4 versus placebo

  3. Safety-bleeding events (ISTH and TIMI) [ Time Frame: up to 1 month post-PCI/angiography ]
    To assess bleeding events (according to International Society on Thrombosis and Haemostasis [ISTH] Major and TIMI Major for information only) after a single subcutaneous injection of RUC-4 versus placebo

  4. Safety-platelet count [ Time Frame: before PCI/angiography, at the end of the PCI/CAG, 6 and 24 hours post-PCI/angiography and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first) ]
    To assess platelet count after a single subcutaneous injection of RUC-4 versus placebo

  5. Safety-injection site reactions [ Time Frame: baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post-PCI/angiography, and at 1-month follow-up ]
    To assess the injection site reactions of a single subcutaneous injection of RUC-4 versus placebo



Information from the National Library of Medicine

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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. Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years.
  2. Weight (by history) between 52 and 130 kg.
  3. Subjects with STEMI, presenting with persistent ischemic chest pain (>10 minutes) and new ≥2 mm ST-segment elevation in two adjacent ECG leads, in whom the total duration of symptoms is anticipated to be within 4 hours.
  4. Verbal witnessed/short written informed consent will be obtained in the acute phase by highly trained paramedics. After the PCI/angiography procedure, written informed consent will be obtained.

Exclusion Criteria:

  1. Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA), except successful intervention for Ventricular Fibrillation (VF).
  2. Presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute (bpm).
  3. Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).
  4. Currently treated with renal dialysis.
  5. Current treatment with oral anticoagulation (Vitamin K antagonists [VKA] or direct oral anticoagulants [DOACs]).
  6. Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
  7. Known history of ischemic or hemorrhagic stroke.
  8. Known severe anemia (regular blood transfusion needed).
  9. Participation in another clinical study with an investigational product or device within the past month.

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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): NCT04825743


Contacts
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Contact: Robert S Hillman, PhD 8587779750 rhillman@celecor.com

Locations
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Czechia
University hospital Brno Not yet recruiting
Brno, Jihomoravský Kraj, Czechia, 625 00
Contact: Prof. P. Kala, MD PhD       Kala.Petr@fnbrno.cz   
St. Anne's University hospital Not yet recruiting
Brno, Jihomoravský Kraj, Czechia, 656 91
Contact: Michal Rezek, MD PhD       michal.rezek@fnusa.cz   
Netherlands
Isala Recruiting
Zwolle, Overijssel, Netherlands, 8025 AB
Contact: Rik S. Hermanides, MD, PhD       r.s.hermanides@isala.nl   
Sponsors and Collaborators
CeleCor Therapeutics
Investigators
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Principal Investigator: Prof. Arnoud WJ Van 't Hof, MD PhD Maastricht University Medical Center
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Responsible Party: CeleCor Therapeutics
ClinicalTrials.gov Identifier: NCT04825743    
Other Study ID Numbers: CEL-03
First Posted: April 1, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: March 2021
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
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases