- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04825743
A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI (CELEBRATE)
A Phase 3 Prospective, Blinded, Randomized, Placebo Controlled, International Multicenter Study to Assess the Safety and Efficacy of a Single SQ Injection of Zalunfiban in Subjects With ST-elevation MI in the Pre-hospital Setting
Study Overview
Status
Conditions
Intervention / Treatment
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/Exception from Informed Consent Requirements (EFIC) process informed consent will be randomized and enrolled in the study. Following a single weight-based dose of subcutaneous study drug administered 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 30 days to report AEs, bleeding events, and injection site reactions, and 12-months to record mortality, and hospitalizations for heart failure or atrial fibrillation, and [in the event of stroke], 90 days (±2 weeks) to record the stroke disability.
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 30 days (+ 7 days) and 12 months (± 1 month).
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Robert S Hillman, PhD
- Phone Number: 8587779750
- Email: rhillman@celecor.com
Study Locations
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Edmonton, Canada
- Recruiting
- University of Alberta
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Principal Investigator:
- Rob Welsh, MD
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Brno, Czechia
- Recruiting
- University Hospital Brno
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Principal Investigator:
- Prof. P. Kala, MD PhD
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Brno, Czechia
- Recruiting
- St. Anne's University Hospital
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Principal Investigator:
- M Rezek, MD PhD
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Aubervilliers, France
- Recruiting
- European Hosital de Paris - GVM Care & Research (La Roseraie)
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Créteil, France
- Recruiting
- Henri Mondor University Hospital
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Montreuil, France
- Recruiting
- André Grégoire Hospital - GHT GPNE
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Paris, France
- Recruiting
- Bichat-Claude Bernard Hospital
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Paris, France
- Not yet recruiting
- European Hospital Georges-Pompidou (HEGP)
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Paris, France
- Recruiting
- Lariboisière Hospital AP-HP
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Paris, France
- Recruiting
- University Hospital De La Pitié-Salpêtrière
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Budapest, Hungary
- Recruiting
- Semmelweis University Heart and Vascular Center
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Principal Investigator:
- B Merkely, MD, PhD
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Kecskemét, Hungary
- Recruiting
- Bacs-Kiskun County Teaching Hospital
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Principal Investigator:
- B Berta, MD, PhD
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's-Hertogenbosch, Netherlands
- Recruiting
- Jeroen Bosch Ziekenhuis
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Principal Investigator:
- J Polad, MD PhD
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Amsterdam, Netherlands
- Not yet recruiting
- Amsterdam UMC
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Amsterdam, Netherlands
- Not yet recruiting
- Amsterdam UMC, Locatie AMC
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Arnhem, Netherlands
- Recruiting
- Rijnstate Arnhem
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Principal Investigator:
- R Pisters, MD PhD
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Blaricum, Netherlands
- Recruiting
- Tergooi Blaricum
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Principal Investigator:
- E K Arkenbout, MD PhD
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Breda, Netherlands
- Recruiting
- Amphia Ziekenhuis
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Principal Investigator:
- B.J.L. van den Branden, MD PhD
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Doetinchem, Netherlands
- Active, not recruiting
- Slingeland Ziekenhuis
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Ede, Netherlands
- Active, not recruiting
- Ziekenhuis Gelderse Vallei
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Enschede, Netherlands
- Recruiting
- Medisch Spectrum Twente
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Principal Investigator:
- K G Van Houwelingen, MD PhD
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Leiden, Netherlands
- Recruiting
- Leiden University Medical Center
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Principal Investigator:
- F Arslan, MD
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Maastricht, Netherlands
- Recruiting
- Maastricht UMC
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Principal Investigator:
- J Vainer, MD
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Nieuwegein, Netherlands, 3435 CM
- Recruiting
- St. Antonius Ziekenhuis
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Principal Investigator:
- J. M. Ten Berg, MD PhD
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Tilburg, Netherlands
- Recruiting
- ETZ TweeSteden
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Principal Investigator:
- B Zwart, MD PhD
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Utrecht, Netherlands
- Recruiting
- UMC Utrecht
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Principal Investigator:
- T P van de Hoef, MD PhD
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Venlo, Netherlands
- Recruiting
- VieCuri Medisch Centrum
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Principal Investigator:
- W S Remkes, MD
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Zwolle, Netherlands
- Active, not recruiting
- Isala
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Limberg
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Heerlen, Limberg, Netherlands
- Recruiting
- Zuyderland MC
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Principal Investigator:
- S Rasoul, MD PhD
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Bucharest, Romania
- Recruiting
- Emergency Clinical Hospital "Bagdasar-Arseni", Bucharest
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Bucharest, Romania
- Recruiting
- Emergency University Hospital Bucharest
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Iaşi, Romania
- Not yet recruiting
- Institute of Cardiovascular Diseases "Prof. George I.M. Georgescu" Iasi
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Târgu-Mureş, Romania
- Recruiting
- Emergency Clinical County Hospital Targu-Mures
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only).
- Weight (by history) between 52 and 130 kg.
- 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 4 hours maximum. If time of symptom onset is uncertain, the cardiologist may be contacted to confirm inclusion criteria.
- Exception from Informed Consent Requirements (EFIC) process, verbal witnessed/ short written informed consent, or written informed consent signed by subject or legally authorized representative/independent witness will be obtained in the acute phase by (para)medics, according to local applicable legal regulations. Subject is willing and able to give informed consent. Written informed consent will be obtained as soon as the subject's clinical condition allows it.
Exclusion Criteria:
- Cardio Pulmonary Resuscitation (CPR) for current Out of Hospital Cardiac Arrest (OHCA).
- Presenting with systolic blood pressure <90 mmHg (confirmed on repeat assessment) and heart rate >100 beats per minute (bpm).
- Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines).
- Currently treated with renal dialysis.
- Current treatment with oral anticoagulation (Vitamin K antagonists [VKA], direct oral anticoagulants [DOACs]), or thrombolytic agents.
- Major surgery, or trauma or bleeding leading to hospitalization, within the past month.
- Known history of ischemic or hemorrhagic stroke.
- Known severe anemia (regular blood transfusion needed).
- Previously enrolled in this study.
- Participation in another clinical study with an investigational product or device within the past month.
Life expectancy less than one year.
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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: zalunfiban Dose 1 (0.110 mg/kg)
Subjects will receive a single subcutaneous injection containing zalunfiban Dose 1 (0.110 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival
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zalunfiban 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 Names:
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Experimental: zalunfiban Dose 2 (0.130 mg/kg)
Subjects will receive a single subcutaneous injection containing zalunfiban Dose 2 (0.130 mg/kg) in the ambulance after diagnosis of STEMI and before hospital arrival
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zalunfiban 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 Names:
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Placebo Comparator: Placebo
Subjects will receive a single subcutaneous injection containing Placebo in the ambulance after diagnosis of STEMI and before hospital arrival
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A placebo will be prepared to those subjects assigned to placebo.
Less than 1 mL (depending on subject's weight) will be administered by subcutaneous injection.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
primary efficacy -clinical outcome
Time Frame: at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo
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As assessed by a 7-point scale. The 7 outcomes, ranking from worst to best are:
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at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo
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primary safety- bleeding events [BARC criteria]
Time Frame: after a single subcutaneous injection of zalunfiban versus placebo at 30 days post-PCI/angiography
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• 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)
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after a single subcutaneous injection of zalunfiban versus placebo at 30 days post-PCI/angiography
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
secondary efficacy-restoration of the coronary artery blood flow
Time Frame: before PCI (or coronary angiography if no PCI is performed)
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To assess restoration of the culprit 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 zalunfiban versus placebo
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before PCI (or coronary angiography if no PCI is performed)
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efficacy-resolution of ST segment deviation
Time Frame: 1 hour post-PCI/angiography
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To assess resolution of ST segment deviation post-PCI/angiography after a single subcutaneous injection of zalunfiban versus placebo
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1 hour post-PCI/angiography
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Efficacy-composite of all cause death, recurrent MI, acute stent thrombosis or blinded bail-out use of IV αIIbβ3 antagonists or IV P2Y12 antagonist
Time Frame: at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo
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To assess a composite of all cause death, recurrent MI, acute stent thrombosis or blinded bail-out use of IV αIIbβ3 antagonists or IV P2Y12 antagonist
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at 30 days follow-up after a single subcutaneous injection of zalunfiban versus placebo
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Efficacy-acute stent thrombosis
Time Frame: up to 24 hours post-PCI
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To assess incidence of definite, probable or possible acute stent thrombosis after a single subcutaneous injection of zalunfiban versus placebo
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up to 24 hours post-PCI
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Safety throughout the study by AE reporting
Time Frame: AEs up to 30 days follow-up; SAEs up to resolution/stabilization, the SAEs mortality, hospitalization for heart failure and atrial fibrillation up to 12-months follow-up
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Recording of AEs and SAEs fibrillation up to 12-months follow-up
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AEs up to 30 days follow-up; SAEs up to resolution/stabilization, the SAEs mortality, hospitalization for heart failure and atrial fibrillation up to 12-months follow-up
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Safety-platelet count
Time Frame: before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first)
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To assess platelet count after a single subcutaneous injection of zalunfiban versus placebo
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before PCI/angiography, at the end of the PCI/angiography, 6 and 24 hours post-PCI/angiography and at hospital discharge/72-hours post-PCI/angiography (whichever occurs first)
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Safety-bleeding events (ISTH and TIMI)
Time Frame: at 30 days follow-up
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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 zalunfiban versus placebo
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at 30 days follow-up
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Safety-bleeding events (GUSTO mild and moderate, BARC type 2, 3 and 5, ISTH minor and/or major and TIMI minor and major)
Time Frame: 30 days follow-up
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To assess incidence of bleeding events according to GUSTO mild and moderate criteria, BARC type 2, 3 and 5 criteria, ISTH minor and or major bleeding, TIMI minor and major criteria
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30 days follow-up
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Safety-injection site reactions
Time Frame: baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post-PCI/angiography, and at 30 days follow-up
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To assess the injection site reactions of a single subcutaneous injection of zalunfiban versus placebo
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baseline, 1-hour post-PCI/angiography, hospital discharge/72-hours post-PCI/angiography, and at 30 days follow-up
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Prof. Arnoud WJ Van 't Hof, MD PhD, Maastricht University Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEL-03
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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