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Antiplatelet Agent
Zalunfiban for Heart Attack (CELEBRATE Trial)
Phase 3
Recruiting
Led By Prof. Arnoud WJ Van 't Hof, MD PhD
Research Sponsored by CeleCor Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Males aged ≥18 years or post-menopausal or surgically sterile females ≥50 years or ≥55 years (for Czech Republic study sites only)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up before pci (or coronary angiography if no pci is performed)
Awards & highlights
CELEBRATE Trial Summary
This trialstudies whether an injection given in the ambulance can help treat people with severe heart attack symptoms. Medics will take patients to hospitals in Europe & North America. Subjects will receive a single injection of a drug or placebo.
Who is the study for?
This trial is for men over 18 and post-menopausal or surgically sterile women over 50, with a weight between 52-130 kg. Participants must have had a heart attack (STEMI) with chest pain and specific ECG changes, but symptoms should not exceed four hours. They need to be able to consent to the study unless emergency conditions apply.Check my eligibility
What is being tested?
The study tests zalunfiban in patients who've just had a severe type of heart attack (STEMI). It's blinded and randomized: participants get either zalunfiban at one of two doses or a placebo by injection in an ambulance on the way to the hospital.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks may include bleeding complications due to zalunfiban's potential blood-thinning properties, allergic reactions, or other drug-related adverse events.
CELEBRATE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man over 18, a woman over 50, or over 55 if participating in the Czech Republic.
CELEBRATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
primary efficacy -clinical outcome
primary safety- bleeding events [BARC criteria]
Secondary outcome measures
Efficacy-acute stent thrombosis
Efficacy-composite of all cause death, recurrent MI, acute stent thrombosis or blinded bail-out use of IV αIIbβ3 antagonists or IV P2Y12 antagonist
Safety throughout the study by AE reporting
+6 moreCELEBRATE Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: zalunfiban Dose 2 (0.130 mg/kg)Experimental Treatment1 Intervention
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
Group II: zalunfiban Dose 1 (0.110 mg/kg)Experimental Treatment1 Intervention
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
Group III: PlaceboPlacebo Group1 Intervention
Subjects will receive a single subcutaneous injection containing Placebo in the ambulance after diagnosis of STEMI and before hospital arrival
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Who is running the clinical trial?
CeleCor TherapeuticsLead Sponsor
2 Previous Clinical Trials
71 Total Patients Enrolled
Prof. Arnoud WJ Van 't Hof, MD PhDPrincipal InvestigatorMaastricht University Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had major surgery, significant injury, or bleeding that required hospitalization in the last month.I do not have an active COVID-19 infection.I am willing and able to give my consent for the trial, verbally or in writing, as soon as possible.I have had a stroke before.I had a severe heart attack with specific ECG changes and chest pain lasting more than 10 minutes but not over 4 hours.I am a man over 18, a woman over 50, or over 55 if participating in the Czech Republic.I am currently receiving CPR for a cardiac arrest that happened outside of a hospital.I am currently undergoing kidney dialysis.I need regular blood transfusions due to severe anemia.I am currently taking blood thinners or clot-dissolving drugs.
Research Study Groups:
This trial has the following groups:- Group 1: zalunfiban Dose 1 (0.110 mg/kg)
- Group 2: zalunfiban Dose 2 (0.130 mg/kg)
- Group 3: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research project actively recruiting participants?
"Data from clinicaltrials.gov reveals that recruitment for this trial is ongoing; the experiment was initially posted on April 24th 2021 and most recently updated in February 8th 2023."
Answered by AI
Is the administration of RUC-4 Dose 1 (0.110 mg/kg) to patients safe?
"There is existing evidence to suggest the safety of RUC-4 Dose 1 (0.110 mg/kg), thus it received a rating of 3 on our scale. This can be attributed to its Phase 3 trial status, implying there are both data proving efficacy and multiple rounds confirming safety."
Answered by AI
What is the current enrolment size of this clinical experiment?
"Affirmative. According to clinicaltrials.gov, this medical experiment has been live since April 24th 2021 and is currently recruiting participants. There are plans to include a total of 2499 people at one site."
Answered by AI
What is the goal of this experiment?
"CeleCor Therapeutics, the company sponsoring this trial, has outlined its primary and secondary objectives for evaluating zalunfiban. The main goal is to assess resolution of ST segment deviation over a certain timeframe before PCI or coronary angiography. Additionally, CeleCor will be gauging injection site reactions as well restoration of culprit artery blood flow (corrected TIMI Frame Count) in patients pre-PCI/angiography post zalunfiban administration compared to placebo."
Answered by AI
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