← Back to Search

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

Must not have

Current known active coronavirus disease 2019 (COVID-19) infection (criteria according to local guidelines)

Major surgery, or trauma or bleeding leading to hospitalization, within the past month

Timeline

Screening 3 weeks

Treatment Varies

Follow Up before pci (or coronary angiography if no pci is performed)

Awards & highlights

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am a man over 18, a woman over 50, or over 55 if participating in the Czech Republic.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have an active COVID-19 infection.

Select...

I have not had major surgery, significant injury, or bleeding that required hospitalization in the last month.

Select...

I have had a stroke before.

Select...

I am currently receiving CPR for a cardiac arrest that happened outside of a hospital.

Select...

I am currently undergoing kidney dialysis.

Select...

I need regular blood transfusions due to severe anemia.

Select...

I am currently taking blood thinners or clot-dissolving drugs.

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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

primary efficacy -clinical outcome

primary safety- bleeding events [BARC criteria]

Secondary study objectives

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 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

0 / 8Eligibility criteria met